Effect of Dapagliflozin on Glycemic Variability

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Dapagliflozin improves glycemic variability in subjects with type 2 diabetes mellitus when added to insulin therapy. The primary objective of this study is to assess the effect of dapagliflozin on glucose variability compared to placebo after 12 weeks of treatment in type 2 diabetic patients with inadequate glycemic control on insulin.

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

Details

• Lead Sponsor: The Catholic University of Korea
• Collaborators: AstraZeneca; Eulji General Hospital; Kyung Hee University Hospital at Gangdong; Severance Hospital
• Treatments: Dapagliflozin; Insulin

Criteria

Inclusion Criteria:

1. Female and male aged 20~70 years

2. Type 2 diabetes patients

3. Treatment on basal insulin therapy ≥0.2U/kg/day(±metformin and/or ±sulfonylurea) for at least 12 weeks

4. Inadequate glycemic control ; HbA1c 7.0%~10.0% at screening

5. Female of childbearing potential agrees to routinely use of adequate contraception from signing of the informed consent throughout the duration of the study

6. Understands the study procedure, alternatives, and risks and voluntarily agrees to participated by giving written informed consent

Exclusion Criteria:

1. Type 1 diabetes(Fasting C-peptide ≤ 0.78ng/dL(or 0.26 nM/L)), secondary diabetes, gestational diabetes

2. Insulin therapy modalities containing short or rapid acting insulin (continuous subcutaneous insulin injection, pre-mixed insulin, basal-bolus insulin)

3. History of diabetic ketoacidosis, hyperglycemic hyperosmolar state

4. Estimated glomerular filtration rate <60 mL/min/1.73 m2

5. History of chronic cystitis or recurrent urinary tract infection

6. Currently on loop diuretics

7. Adrenal insufficiency, pituitary insufficiency

8. Currently on medication known to affect glucose metabolism (e.g. corticosteroids, immunosuppressants)

9. Hemoglobin <10g/dL in female, <12g/dL in male

10. Abnormal liver function (AST/ALT > x3 upper normal limit)

11. On weight loss program or taking weight loss medication

12. NYHA class III, IV congestive heart failure

13. History of acute myocardial infarction, unstable angina, coronary artery bypass graft or stroke within 6 months

14. History of bladder cancer

15. History of malignancy within 5 years

16. Pregnant or lactating women

17. History of excessive alcohol abuse (≥30g/day)

18. Hypersensitivity to SGLT2 inhibitors

19. Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

20. Subject who the investigator deems inappropriate to participate in this study