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GWMD1092 - GWP42003 : GWP42004 Together Plus Alone in Type II Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01217112
Recruitment Status : Completed
First Posted : October 8, 2010
Results First Posted : January 20, 2014
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Dyslipidemias
Diabetes Mellitus, Type 2
Interventions Drug: GWP42003
Drug: GWP42004
Drug: Placebo
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description Contains 5 mg each of GWP42003 and GWP42004 Contains 100 mg GWP42003 and 5 mg GWP42004 Contains 100 mg GWP42003 and placebo (excipients only) Contains GWP42004 5 mg and placebo (excipients only) Contains excipients only
Period Title: Overall Study
Started 11 12 13 12 14
Completed 11 10 12 10 13
Not Completed 0 2 1 2 1
Reason Not Completed
Adverse Event             0             2             0             2             0
Withdrawal by Subject             0             0             1             0             0
Physician Decision             0             0             0             0             1
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo Total
Hide Arm/Group Description Contains 5 mg each of GWP42003 and GWP42004 Contains 100 mg GWP42003 and 5 mg GWP42004 Contains 100 mg GWP42003 and placebo (excipients only) Contains GWP42004 5 mg and placebo (excipients only) Contains excipients only Total of all reporting groups
Overall Number of Baseline Participants 11 12 13 12 14 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 13 participants 12 participants 14 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  72.7%
11
  91.7%
11
  84.6%
8
  66.7%
10
  71.4%
48
  77.4%
>=65 years
3
  27.3%
1
   8.3%
2
  15.4%
4
  33.3%
4
  28.6%
14
  22.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 13 participants 12 participants 14 participants 62 participants
59.33  (8.75) 57.96  (8.11) 56.80  (9.92) 62.45  (12.58) 58.63  (7.72) 58.98  (9.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 13 participants 12 participants 14 participants 62 participants
Female
5
  45.5%
3
  25.0%
3
  23.1%
2
  16.7%
7
  50.0%
20
  32.3%
Male
6
  54.5%
9
  75.0%
10
  76.9%
10
  83.3%
7
  50.0%
42
  67.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 11 participants 12 participants 13 participants 12 participants 14 participants 62 participants
11 12 13 12 14 62
1.Primary Outcome
Title The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 12 13
Mean (Standard Deviation)
Unit of Measure: mmol/l
0.00  (0.09) 0.04  (0.07) -0.04  (0.14) 0.00  (0.14) 0.02  (0.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by analysis of covariance (ANCOVA). The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.766
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 90%
-0.09 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.044
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.424
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 90%
-0.04 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.043
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.412
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval (2-Sided) 90%
-0.10 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.041
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.668
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 90%
-0.05 to 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.043
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 9 12 14
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.04  (0.12) -0.06  (0.08) -0.11  (0.08) -0.01  (0.16) -0.02  (0.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.978
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.08 to 0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.046
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.864
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 90%
-0.08 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.045
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.537
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval (2-Sided) 90%
-0.12 to 0.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.050
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.260
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 90%
-0.02 to 0.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.045
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 12 13
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.53  (0.78) -0.27  (0.32) -0.22  (0.50) -0.13  (0.44) -0.09  (0.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.31
Confidence Interval (2-Sided) 90%
-0.61 to -0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.180
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.583
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 90%
-0.20 to 0.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.177
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.388
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 90%
-0.14 to 0.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.169
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.580
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-0.19 to 0.38
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.170
Estimation Comments [Not Specified]
4.Secondary Outcome
Title The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 9 12 14
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.12  (0.83) -0.23  (0.28) -0.11  (0.52) -0.11  (0.45) -0.16  (0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.829
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 90%
-0.29 to 0.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.198
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.575
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 90%
-0.22 to 0.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.196
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.356
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 90%
-0.15 to 0.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.203
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.472
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval (2-Sided) 90%
-0.18 to 0.45
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.188
Estimation Comments [Not Specified]
5.Secondary Outcome
Title The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 8 11 11 12 13
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.29  (0.62) -0.13  (0.36) -0.11  (0.40) -0.02  (0.50) 0.07  (0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.115
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.29
Confidence Interval (2-Sided) 90%
-0.59 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.181
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.782
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 90%
-0.25 to 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.177
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.902
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 90%
-0.27 to 0.31
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.173
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.28 to 0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.166
Estimation Comments [Not Specified]
6.Secondary Outcome
Title The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 9 12 14
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.03  (0.49) -0.16  (0.26) -0.08  (0.43) -0.08  (0.41) -0.06  (0.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.956
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.23 to 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.143
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.705
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 90%
-0.19 to 0.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.144
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.466
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.11
Confidence Interval (2-Sided) 90%
-0.14 to 0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.148
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.876
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 90%
-0.21 to 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.136
Estimation Comments [Not Specified]
7.Secondary Outcome
Title The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment
Hide Description An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 8 11 11 12 13
Mean (Standard Deviation)
Unit of Measure: ratio
0.03  (0.11) 0.04  (0.05) -0.02  (0.08) 0.02  (0.09) 0.01  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.408
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 90%
-0.03 to 0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.034
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.714
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.04 to 0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.032
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.267
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 90%
-0.09 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.032
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.484
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 90%
-0.03 to 0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.032
Estimation Comments [Not Specified]
8.Secondary Outcome
Title The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Hide Description An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 9 12 14
Mean (Standard Deviation)
Unit of Measure: ratio
-0.01  (0.11) 0.00  (0.05) -0.02  (0.08) 0.03  (0.12) 0.01  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.560
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 90%
-0.09 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.039
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.956
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.06 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.037
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.403
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval (2-Sided) 90%
-0.10 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.039
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 90%
-0.04 to 0.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.037
Estimation Comments [Not Specified]
9.Secondary Outcome
Title The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 9 12 14
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.06  (0.37) -0.01  (0.16) 0.08  (0.19) -0.02  (0.24) -0.08  (0.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.815
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 90%
-0.16 to 0.21
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.108
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.418
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-0.09 to 0.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.105
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.236
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 90%
-0.05 to 0.32
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.111
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 90%
-0.11 to 0.23
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.103
Estimation Comments [Not Specified]
10.Secondary Outcome
Title The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 12 13
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.47  (0.54) 0.14  (0.28) 0.09  (0.55) 0.09  (0.66) -0.12  (0.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.329
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 90%
-0.64 to 0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.241
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.232
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 90%
-0.11 to 0.68
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.236
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.31
Confidence Interval (2-Sided) 90%
-0.06 to 0.68
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.222
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.302
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval (2-Sided) 90%
-0.15 to 0.63
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.232
Estimation Comments [Not Specified]
11.Secondary Outcome
Title The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 9 12 14
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.16  (0.56) 0.12  (0.26) 0.16  (0.34) 0.05  (0.59) -0.03  (0.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.614
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.12
Confidence Interval (2-Sided) 90%
-0.50 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.231
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.669
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 90%
-0.28 to 0.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.227
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.621
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 90%
-0.28 to 0.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.240
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.867
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 90%
-0.33 to 0.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.222
Estimation Comments [Not Specified]
12.Secondary Outcome
Title The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 12 14
Mean (Standard Deviation)
Unit of Measure: umol/l
-2.86  (8.84) -3.51  (10.88) -4.92  (6.04) 0.64  (11.32) -3.41  (6.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.335
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.55
Confidence Interval (2-Sided) 90%
-1.84 to 6.95
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.624
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.36
Confidence Interval (2-Sided) 90%
-1.90 to 6.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.545
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.900
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) 90%
-3.72 to 4.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.406
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.02
Confidence Interval (2-Sided) 90%
1.86 to 10.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.486
Estimation Comments [Not Specified]
13.Secondary Outcome
Title The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 12 13
Mean (Standard Deviation)
Unit of Measure: umol/l
-0.19  (0.84) 0.18  (0.51) 0.11  (0.53) 0.08  (0.66) 0.16  (0.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.325
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 90%
-0.65 to 0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.245
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.438
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 90%
-0.21 to 0.59
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.238
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-0.29 to 0.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.226
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.11
Confidence Interval (2-Sided) 90%
-0.50 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.232
Estimation Comments [Not Specified]
14.Secondary Outcome
Title The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment
Hide Description A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 12 13
Mean (Standard Deviation)
Unit of Measure: ratio
-0.01  (0.23) 0.07  (0.15) 0.08  (0.13) 0.01  (0.14) 0.07  (0.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.07
Confidence Interval (2-Sided) 90%
-0.17 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.058
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.727
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 90%
-0.07 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.056
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.593
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 90%
-0.06 to 0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.053
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval (2-Sided) 90%
-0.20 to -0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.056
Estimation Comments [Not Specified]
15.Secondary Outcome
Title The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 12 13
Mean (Standard Deviation)
Unit of Measure: mmol/l
0.06  (0.17) -0.03  (0.23) -0.05  (0.30) -0.02  (0.18) 0.01  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.236
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 90%
-0.04 to 0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.084
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.579
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 90%
-0.09 to 0.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.082
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 90%
-0.15 to 0.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.077
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.467
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 90%
-0.08 to 0.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.081
Estimation Comments [Not Specified]
16.Secondary Outcome
Title The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 11 13
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.23  (2.02) 0.44  (2.00) 0.41  (0.82) -0.76  (1.00) 0.38  (1.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.533
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval (2-Sided) 90%
-1.41 to 0.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.613
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.804
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.15
Confidence Interval (2-Sided) 90%
-0.84 to 1.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.585
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.916
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 90%
-0.87 to 0.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.556
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.23
Confidence Interval (2-Sided) 90%
-2.20 to -0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.583
Estimation Comments [Not Specified]
17.Secondary Outcome
Title The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 10 13 12 13
Mean (Standard Deviation)
Unit of Measure: umol/l
2.8  (42.06) 14.5  (29.53) -2.6  (20.41) 1.1  (11.68) 9.5  (19.68)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.366
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.90
Confidence Interval (2-Sided) 90%
-28.06 to 8.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.838
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.844
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.11
Confidence Interval (2-Sided) 90%
-15.81 to 20.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.692
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.96
Confidence Interval (2-Sided) 90%
-32.76 to 0.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.026
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.518
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.67
Confidence Interval (2-Sided) 90%
-23.86 to 10.51
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.256
Estimation Comments [Not Specified]
18.Secondary Outcome
Title The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 12 14
Mean (Standard Deviation)
Unit of Measure: percent
0.14  (1.41) 0.16  (0.44) 0.08  (0.44) -0.03  (0.22) 0.31  (0.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.576
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.17
Confidence Interval (2-Sided) 90%
-0.66 to 0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.294
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.648
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval (2-Sided) 90%
-0.60 to 0.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.283
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.447
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval (2-Sided) 90%
-0.66 to 0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.269
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.273
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.31
Confidence Interval (2-Sided) 90%
-0.79 to 0.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.283
Estimation Comments [Not Specified]
19.Secondary Outcome
Title The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])
Hide Description A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 6 10 12 11 13
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.07  (1.89) 1.09  (3.81) -0.78  (1.51) 0.22  (1.85) 0.42  (1.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.615
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.56
Confidence Interval (2-Sided) 90%
-2.40 to 1.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.097
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.342
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.93
Confidence Interval (2-Sided) 90%
-0.70 to 2.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.973
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.314
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.95
Confidence Interval (2-Sided) 90%
-2.52 to 0.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.934
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.889
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval (2-Sided) 90%
-1.48 to 1.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.964
Estimation Comments [Not Specified]
20.Secondary Outcome
Title The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)
Hide Description At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 7 9 12 11 13
Mean (Standard Deviation)
Unit of Measure: pmol/l
80.9  (223.91) -156.6  (358.53) -193.5  (232.17) 83.5  (427.94) -40.8  (475.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.764
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 50.89
Confidence Interval (2-Sided) 90%
-232.02 to 333.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 168.459
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.654
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -70.76
Confidence Interval (2-Sided) 90%
-333.96 to 192.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 156.720
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.450
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -111.50
Confidence Interval (2-Sided) 90%
-357.17 to 134.16
Parameter Dispersion
Type: Standard Error of the mean
Value: 146.276
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.517
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 97.42
Confidence Interval (2-Sided) 90%
-153.02 to 347.86
Parameter Dispersion
Type: Standard Error of the mean
Value: 149.124
Estimation Comments [Not Specified]
21.Secondary Outcome
Title The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 11 13
Mean (Standard Deviation)
Unit of Measure: pmol/l
12.01  (56.22) -6.06  (104.78) 13.44  (49.03) 45.62  (183.92) 2.79  (61.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.840
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.33
Confidence Interval (2-Sided) 90%
-60.28 to 76.94
Parameter Dispersion
Type: Standard Error of the mean
Value: 40.940
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.834
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.31
Confidence Interval (2-Sided) 90%
-57.92 to 74.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 39.521
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.767
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.62
Confidence Interval (2-Sided) 90%
-77.06 to 53.81
Parameter Dispersion
Type: Standard Error of the mean
Value: 39.044
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.289
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 42.51
Confidence Interval (2-Sided) 90%
-23.99 to 109.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 39.680
Estimation Comments [Not Specified]
22.Secondary Outcome
Title The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment
Hide Description At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 12 12 14
Mean (Standard Deviation)
Unit of Measure: nmol/l
0.02  (0.15) 0.09  (0.28) -0.03  (0.18) 0.12  (0.31) 0.09  (0.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.569
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.06
Confidence Interval (2-Sided) 90%
-0.24 to 0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.106
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.984
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.17 to 0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.101
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments v Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval (2-Sided) 90%
-0.30 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.098
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.895
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.15 to 0.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.099
Estimation Comments [Not Specified]
23.Secondary Outcome
Title The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment
Hide Description Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 11 13
Mean (Standard Deviation)
Unit of Measure: IR score
0.19  (1.00) -0.19  (2.54) 0.35  (1.20) 0.64  (3.15) 0.09  (1.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 90%
-1.13 to 1.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.745
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.826
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Confidence Interval (2-Sided) 90%
-1.05 to 1.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.721
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.693
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.28
Confidence Interval (2-Sided) 90%
-1.46 to 0.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.703
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GWP42004 and Placebo, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.536
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.45
Confidence Interval (2-Sided) 90%
-0.76 to 1.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.722
Estimation Comments [Not Specified]
24.Secondary Outcome
Title The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment
Hide Description Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.
Time Frame Baseline (Day 1) and End of treatment (Day 92)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title 1:1 GWP42003 : GWP42004 20:1 GWP42003 : GWP42004 GWP42003 and Placebo GWP42004 and Placebo Placebo
Hide Arm/Group Description:
Contains 5 mg each of GWP42003 and GWP42004
Contains 100 mg GWP42003 and 5 mg GWP42004
Contains 100 mg GWP42003 and placebo (excipients only)
Contains GWP42004 5 mg and placebo (excipients only)
Contains excipients only
Overall Number of Participants Analyzed 9 11 13 11 13
Mean (Standard Deviation)
Unit of Measure: percent sensitivity
-5.26  (8.62) -1.71  (12.62) 1.71  (26.48) 6.47  (27.00) -4.07  (13.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.878
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.33
Confidence Interval (2-Sided) 90%
-15.80 to 13.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.633
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 20:1 GWP42003 : GWP42004, Placebo
Comments Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance l