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 HbA1Cglycemic 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
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