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Effect of Dapagliflozin on Glycemic Variability

Information source: The Catholic University of Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Dapagliflozin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: The Catholic University of Korea

Official(s) and/or principal investigator(s):
Kun-Ho Yoon, Ph.D., Principal Investigator, Affiliation: Seoul St. Mary's Hospital

Overall contact:
Kun-Ho Yoon, Ph.D., Email: yoonk@catholic.ac.kr

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Glycemic Variability (mean amplitude of glycemic excursion)

Glycemic Variability (Coefficient of Variation)

Glycemic Variability (Standard Deviation)

Secondary outcome:

glycemic control variables HbA1C

glycemic control variables Fasting Plasma Glucose

lipid profile Total cholesterol

lipid profile Triglyceride

lipid profile HDL-cholesterol

lipid profile LDL-cholesterol

glycemic control variables Percentage of patients achieving HbA1c < 7%

glycemic control variables Percentage of patients achieving HbA1c < 6.5%

glycemic control variables 24hr urinary glucose excretion

glycemic control variables Changes in insulin dose

blood pressure SBP

blood pressure DBP

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.

Eligibility

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Kun-Ho Yoon, Ph.D., Email: yoonk@catholic.ac.kr

Additional Information

Starting date: June 2015
Last updated: June 1, 2015

Page last updated: August 23, 2015

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