Effect of Dapagliflozin on Glycemic Variability

NCT ID: NCT02459353

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-05-31

Brief 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.

Detailed Description

This study is a multicenter, randomized, double-blind, placebo-controlled phase 4 study to evaluate whether treatment with dapagliflozin add-on to insulin reduces glucose variability in type 2 Diabetes Mellitus. The study will recruit type 2 Diabetes Mellitus patients with inadequate glucose control on insulin treatment with or without metformin or sulphonylurea. It is estimated that 90 type 2 diabetic patients will be enrolled. After randomization, a total 12 week treatment of dapagliflozin or matching placebo will be administered. Before and after treatment, tests for efficacy and safety outcomes will be performed.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

dapagliflozin 10mg

a group which treated with dapagliflozin 10mg plus basal insulin therapy

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

placebo 10mg

a group which treated with dapagliflozin placebo plus basal insulin therapy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Dapagliflozin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Severance Hospital

OTHER

Sponsor Role: collaborator

Eulji General Hospital

OTHER

Sponsor Role: collaborator

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role: collaborator

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Kun-Ho Yoon

Professor of endocrinology division, Department of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kun-Ho Yoon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

Seoul St.Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

ISSDAPA0006

Identifier Type: -

Identifier Source: org_study_id