A Study of GWP42004 as Add on to Metformin in the Treatment of Participants With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title: A Randomised, Double Blind, Placebo Controlled, Parallel Group, Dose Ranging Study of GWP42004 as Add on to Metformin in the Treatment of Participants With Type 2 Diabetes

Status Completed

Clinical Trial Summary

A study to compare the change in glycaemic control in participants with Type 2 diabetes when treated with GWP42004 or placebo as add-on therapy to metformin over a period of 12 weeks. The safety and tolerability of GWP42004 compared with placebo will also be assessed.

Clinical Trial Description

This 14 week (one week baseline, 12 week treatment period and one week follow-up), multicentre, randomised, double blind, placebo controlled, parallel group study will evaluate the efficacy, safety and tolerability of 2, 5 and 15 mg of GWP42004 as add on to metformin compared with placebo in participants with Type 2 diabetes.

Eligible participants will enter the study at a screening visit (Visit 1, Day -7) where the following information will be obtained for each participant:

1. Informed consent

2. Demographics

3. Medical history

4. Concomitant medications

5. Electrocardiogram (ECG)

6. Physical examination

7. Vital signs

8. Body weight

9. Height

10. Body Mass Index (BMI)

11. Beck Depression Inventory-II (BDI-II)

12. Safety blood test (biochemistry and haematology)

13. Efficacy blood test (HbA1c)

14. Urinalysis (including drugs of abuse screen)

15. Pregnancy test (if appropriate)

Once all inclusion and exclusion criteria have been reviewed, participants will be commence a seven day baseline period. The day before Visit 2, participants will perform blood glucose tests and record the results, along with the associated time of assessment, in the study diary. Participants will then fast overnight.

Participants will return to the clinic at Visit 2 (Day 1) and following review of all inclusion and exclusion criteria, the following information will be obtained for each participant:

1. Body weight

2. BMI

3. Physical examination

4. Vital signs

5. Safety blood test (biochemistry and haematology)

6. GWP42004 exposure blood test (plasma levels)

7. Efficacy blood test (HbA1c, fasting plasma glucose, serum fructosamine, fasting plasma insulin, HOMA2-IR, pro-insulin, C-peptide, HOMA2-%B, total cholesterol, HDL-cholesterol, serum triglycerides, C-reactive protein)

8. Urinalysis

9. Concomitant medications

10. Adverse events (AEs)

11. BDI-II

12. Columbia-Suicide Severity Rating Scale (C-SSRS)

13. Diabetes Treatment Satisfaction Questionnaire (DTSQs)

14. Overall health Visual Analogue Scale (VAS)

15. Cannabis withdrawal scale assessment (UK only).

Participants will then be randomised to receive either GWP42004 (2, 5 or 15 mg bid) or placebo to be taken adjunctive to their currently prescribed medication. The first dose will be administered and a Oral Glucose Tolerance Test (OGTT) performed.

A third (Visit 3, Day 29) and fourth (Visit 4, Day 57) visit will take place mid-treatment. The day before these visits, participants will perform blood glucose tests and record the results, along with the associated time of assessment, in the study diary. Participants will then fast overnight. The following information will be obtained for each participant at Visits 3 and 4:

1. Body weight

2. BMI

3. Physical examination

4. Vital signs

5. Safety blood test (biochemistry and haematology)

6. Efficacy blood test (HbA1c, fasting plasma glucose, fasting plasma insulin, HOMA2-IR, HOMA2-%B)

7. Urinalysis

8. Concomitant medications

9. AEs

10. BDI-II

11. C-SSRS

12. DTSQs

13. Overall health VAS

A cannabis withdrawal scale assessment will be made by telephone (UK only) between Visits 4 and 5.

A further visit will take place at the end of treatment (Visit 5, Day 85). Two days before this visit, a cannabis withdrawal scale assessment will be made by telephone (UK only). The day before Visit 5, participants will perform blood glucose tests and record the results, along with the associated time of assessment, in the study diary. Participants will then fast overnight. The following information will be obtained for each participant at Visit 5:

the following information will be obtained for each participant:

1. Body weight

2. BMI

3. Physical examination

4. ECG

5. Vital signs

6. Safety blood test (biochemistry and haematology)

7. GWP42004 exposure blood test (plasma levels)

8. Efficacy blood test (HbA1c, fasting plasma glucose, serum fructosamine, fasting plasma insulin, HOMA2-IR, pro-insulin, C-peptide, HOMA2-%B, total cholesterol, HDL-cholesterol, serum triglycerides, C-reactive protein)

9. Urinalysis (including drugs of abuse screen)

10. Pregnancy test (if appropriate)

11. Concomitant medications

12. Adverse events (AEs)

13. BDI-II

14. OGTT

15. C-SSRS

16. DTSQs

17. Overall health VAS

One, three and seven days following Visit 5 (Days 86, 89 and 92, respectively), further cannabis withdrawal scale assessments will be made by telephone (UK only). A final review of AEs and concomitant medications will be made by telephone to all participants on Day 92. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

• NCT number: NCT02053272
• Study type: Interventional
• Source: Jazz Pharmaceuticals
• Status: Completed
• Phase: Phase 2
• Start date: February 2014
• Completion date: February 2016