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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd
ClinicalTrials.gov Identifier:
NCT01217112
First received: October 7, 2010
Last updated: September 9, 2014
Last verified: September 2014
History of Changes
Results First Received: October 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Dyslipidemias
Diabetes Mellitus, Type 2
Interventions: Drug: GWP42003
Drug: GWP42004
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
1:1 GWP42003 : GWP42004 Contains 5 mg each of GWP42003 and GWP42004
20:1 GWP42003 : GWP42004 Contains 100 mg GWP42003 and 5 mg GWP42004
GWP42003 and Placebo Contains 100 mg GWP42003 and placebo (excipients only)
GWP42004 and Placebo Contains GWP42004 5 mg and placebo (excipients only)
Placebo Contains excipients only

Participant Flow:   Overall Study
    1:1 GWP42003 : GWP42004     20:1 GWP42003 : GWP42004     GWP42003 and Placebo     GWP42004 and Placebo     Placebo  
STARTED     11     12     13     12     14  
COMPLETED     11     10     12     10     13  
NOT COMPLETED     0     2     1     2     1  
Adverse Event                 0                 2                 0                 2                 0  
Withdrawal by Subject                 0                 0                 1                 0                 0  
Physician Decision                 0                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
1:1 GWP42003 : GWP42004 Contains 5 mg each of GWP42003 and GWP42004
20:1 GWP42003 : GWP42004 Contains 100 mg GWP42003 and 5 mg GWP42004
GWP42003 and Placebo Contains 100 mg GWP42003 and placebo (excipients only)
GWP42004 and Placebo Contains GWP42004 5 mg and placebo (excipients only)
Placebo Contains excipients only
Total Total of all reporting groups

Baseline Measures
    1:1 GWP42003 : GWP42004     20:1 GWP42003 : GWP42004     GWP42003 and Placebo     GWP42004 and Placebo     Placebo     Total  
Number of Participants  
[units: participants]
 		  11     12     13     12     14     62  
Age  
[units: participants]
 		           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     8     11     11     8     10     48  
>=65 years     3     1     2     4     4     14  
Age  
[units: years]
Mean (Standard Deviation) 		  59.33  (8.75)     57.96  (8.11)     56.80  (9.92)     62.45  (12.58)     58.63  (7.72)     58.98  (9.41)  
Gender  
[units: participants]
 		           
Female     5     3     3     2     7     20  
Male     6     9     10     10     7     42  
Region of Enrollment  
[units: participants]
 		           
United Kingdom     11     12     13     12     14     62  



  Outcome Measures
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1.  Primary:   The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 1

2.  Secondary:   The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 2

3.  Secondary:   The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 3

4.  Secondary:   The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 4

5.  Secondary:   The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 5

6.  Secondary:   The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 6

7.  Secondary:   The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 7

8.  Secondary:   The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 8

9.  Secondary:   The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 9

10.  Secondary:   The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 10

11.  Secondary:   The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 11

12.  Secondary:   The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 12

13.  Secondary:   The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 13

14.  Secondary:   The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 14

15.  Secondary:   The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 15

16.  Secondary:   The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 16

17.  Secondary:   The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 17

18.  Secondary:   The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 18

19.  Secondary:   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])   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 19

20.  Secondary:   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)   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 20

21.  Secondary:   The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 21

22.  Secondary:   The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 22

23.  Secondary:   The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 23

24.  Secondary:   The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 24

25.  Secondary:   The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 25

26.  Secondary:   The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 26

27.  Secondary:   The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 27

28.  Secondary:   The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 28

29.  Secondary:   The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 29

30.  Secondary:   The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 30

31.  Secondary:   The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 31

32.  Secondary:   The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 32

33.  Secondary:   The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 33

34.  Secondary:   The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 34

35.  Secondary:   The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 35

36.  Secondary:   The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 36

37.  Secondary:   The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 37

38.  Secondary:   The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 38

39.  Secondary:   The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 39

40.  Secondary:   The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 40

41.  Secondary:   The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 41

42.  Secondary:   The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and End of treatment (Day 92) ]
  Show Outcome Measure 42

43.  Secondary:   Adverse Events as a Measure of Patient Safety   [ Time Frame: Day 1 - Day 92 ]
  Show Outcome Measure 43

44.  Secondary:   The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment   [ Time Frame: Baseline (Day 1) and the End of Treatment (Day 92) ]
  Show Outcome Measure 44


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Mr Richard Potts, Clinical Operations Director
Organization: GW Research Ltd.
phone: 0044 1223266800
e-mail: rp@gwpharm.com



Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT01217112     History of Changes
Other Study ID Numbers: GWMD1092
2010-020458-33 ( EudraCT Number )
Study First Received: October 7, 2010
Results First Received: October 22, 2013
Last Updated: September 9, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee