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

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

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
Overall Participants Analyzed  [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

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

43.  Secondary:

Adverse Events as a Measure of Patient Safety   [ Time Frame: Day 1 - Day 92 ]

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) ]

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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