Saxagliptin in Combination With Dapagliflozin - Effects on Islet Cell Function

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate alpha- and beta-cell function during combination treatment with saxagliptin in addition to dapagliflozin and metformin compared to placebo in addition to dapagliflozin and metformin in subjects with T2DM on stable metformin background therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dr. Thomas Forst
• Treatments: Metformin; Saxagliptin

Criteria

Inclusion Criteria:

1. Diabetes mellitus type 2 for at least three months prior to Screening

2. HbA1c 7.0%-9.9%, both inclusive

3. Treatment with metformin (daily dose 1500 - 3000 mg)

4. Age 30-75 years, both inclusive

5. BMI 25-35 kg/m^2, both inclusive

Exclusion Criteria:

1. Use of any oral antidiabetic treatment except for metformin (i.e., sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors) within the last three months prior to Screening

2. Use of insulin or GLP-1 analogues within three months prior to Screening

3. Treatment with any other investigational drug within three months before screening

4. History of diabetes mellitus type 1

5. Acute infections within the last two weeks prior to Screening

6. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures

7. History of severe or multiple allergies

8. GFR (as calculated by the Cockroft-Gault equation) < 60 ml/min at Screening

9. State after kidney transplantation

10. Laboratory safety value(s) outside the reference range and deemed clinically relevant by the Investigator

11. Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner

12. Pregnancy or breast feeding

13. Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 90 mmHg at Screening

14. Acute myocardial infarction or cerebral event (stroke/TIA) within six months prior to Screening

15. Uncontrolled unstable angina pectoris or history of pericarditis, myocarditis, endocarditis

16. Increased risk of thromboembolism, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator

17. Hemodynamic relevant aortic stenosis, Aortic aneurysm

18. Repeated episodes of severe hypoglycaemia within six months prior to Screening

19. History of diabetic ketoacidosis, praecoma diabeticum, or diabetic coma

20. Recurrent urogenital infections

21. Haematuria

22. History of pancreatitis

23. Progressive fatal disease

24. Elective surgery planned during study participation

25. Acute or scheduled investigation with iodine containing radiopaque material

26. History of drug or alcohol abuse in the past two years

27. Donation of blood, major blood loss (>=500 ml), or major surgery within the last three months prior to Screening

28. Active hepatitis B, measured by positive tests of surface antigen HBsAg and/or active hepatitis C, measured by positive hepatitis C virus antibody tests (HCV) at Screening

29. Positive human immunodeficiency virus (HIV) antibodies or HIV 1 Ag at Screening