Effect of Dapagliflozin on Glycemic Variability

Type 2 Diabetes Mellitus Clinical Trial

— DIVE  

Official title:

Effect of Dapagliflozin on Glycemic Variability as an add-on Therapy in Subjects With Type 2 Diabetes Mellitus With in Inadequate Glycemic Control in Insulin: a Multicenter, Placebo-controlled, Double-blind, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459353
• Other study ID #: ISSDAPA0006
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2015
• Last updated: July 12, 2017
• Start date: August 2015
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul St.Mary's Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
The Catholic University of Korea	AstraZeneca, Eulji General Hospital, Kyung Hee University Hospital at Gangdong, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Variability (mean amplitude of glycemic excursion)	MAGE(mean amplitude of glycemic excursion)	baseline and 12 weeks
Primary	Glycemic Variability (Coefficient of Variation)	CV (Coefficient of Variation)	baseline and 12 weeks
Primary	Glycemic Variability (Standard Deviation)	SD (Standard Deviation)	baseline and 12 weeks
Secondary	glycemic control variables HbA1C	HbA1C	baseline and each visit(6weeks, 12weeks)
Secondary	glycemic control variables Fasting Plasma Glucose	Fasting Plasma Glucose	baseline and each visit(6weeks, 12weeks)
Secondary	lipid profile Total cholesterol	Total cholesterol	baseline and each visit(6weeks, 12weeks)
Secondary	lipid profile Triglyceride	Triglyceride	baseline and each visit(6weeks, 12weeks)
Secondary	lipid profile HDL-cholesterol	HDL-cholesterol	baseline and each visit(6weeks, 12weeks)
Secondary	lipid profile LDL-cholesterol	LDL-cholesterol	baseline and each visit(6weeks, 12weeks)
Secondary	glycemic control variables Percentage of patients achieving HbA1c < 7%	Percentage of patients achieving HbA1c < 7%	12weeks
Secondary	glycemic control variables Percentage of patients achieving HbA1c < 6.5%	Percentage of patients achieving HbA1c < 6.5%	12weeks
Secondary	glycemic control variables 24hr urinary glucose excretion	24hr urinary glucose excretion	baseline and 12weeks
Secondary	glycemic control variables Changes in insulin dose	Changes in insulin dose	baseline and each visit(6weeks, 12weeks)
Secondary	blood pressure SBP	SBP	baseline and each visit(6weeks, 12weeks)
Secondary	blood pressure DBP	DBP	baseline and each visit(6weeks, 12weeks)