Back to resultsEffect of Dapagliflozin on Glycemic Variability (DIVE)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring dapagliflozin, glucose variability
Eligibility Criteria
Inclusion Criteria:
- Female and male aged 20~70 years
- Type 2 diabetes patients
- Treatment on basal insulin therapy ≥0.2U/kg/day(±metformin and/or ±sulfonylurea) for at least 12 weeks
- Inadequate glycemic control ; HbA1c 7.0%~10.0% at screening
- Female of childbearing potential agrees to routinely use of adequate contraception from signing of the informed consent throughout the duration of the study
- Understands the study procedure, alternatives, and risks and voluntarily agrees to participated by giving written informed consent
Exclusion Criteria:
- Type 1 diabetes(Fasting C-peptide ≤ 0.78ng/dL(or 0.26 nM/L)), secondary diabetes, gestational diabetes
- Insulin therapy modalities containing short or rapid acting insulin (continuous subcutaneous insulin injection, pre-mixed insulin, basal-bolus insulin)
- History of diabetic ketoacidosis, hyperglycemic hyperosmolar state
- Estimated glomerular filtration rate <60 mL/min/1.73 m2
- History of chronic cystitis or recurrent urinary tract infection
- Currently on loop diuretics
- Adrenal insufficiency, pituitary insufficiency
- Currently on medication known to affect glucose metabolism (e.g. corticosteroids, immunosuppressants)
- Hemoglobin <10g/dL in female, <12g/dL in male
- Abnormal liver function (AST/ALT > x3 upper normal limit)
- On weight loss program or taking weight loss medication
- NYHA class III, IV congestive heart failure
- History of acute myocardial infarction, unstable angina, coronary artery bypass graft or stroke within 6 months
- History of bladder cancer
- History of malignancy within 5 years
- Pregnant or lactating women
- History of excessive alcohol abuse (≥30g/day)
- Hypersensitivity to SGLT2 inhibitors
- Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- Subject who the investigator deems inappropriate to participate in this study
Sites / Locations
- Seoul St.Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dapagliflozin 10mg
placebo 10mg
Arm Description
a group which treated with dapagliflozin 10mg plus basal insulin therapy
a group which treated with dapagliflozin placebo plus basal insulin therapy
Outcomes
Primary Outcome Measures
Glycemic Variability (mean amplitude of glycemic excursion)
MAGE(mean amplitude of glycemic excursion)
Glycemic Variability (Coefficient of Variation)
CV (Coefficient of Variation)
Glycemic Variability (Standard Deviation)
SD (Standard Deviation)
Secondary Outcome Measures
glycemic control variables HbA1C
HbA1C
glycemic control variables Fasting Plasma Glucose
Fasting Plasma Glucose
lipid profile Total cholesterol
Total cholesterol
lipid profile Triglyceride
Triglyceride
lipid profile HDL-cholesterol
HDL-cholesterol
lipid profile LDL-cholesterol
LDL-cholesterol
glycemic control variables Percentage of patients achieving HbA1c < 7%
Percentage of patients achieving HbA1c < 7%
glycemic control variables Percentage of patients achieving HbA1c < 6.5%
Percentage of patients achieving HbA1c < 6.5%
glycemic control variables 24hr urinary glucose excretion
24hr urinary glucose excretion
glycemic control variables Changes in insulin dose
Changes in insulin dose
blood pressure SBP
SBP
blood pressure DBP
DBP
Full Information
NCT ID
NCT02459353
First Posted
May 26, 2015
Last Updated
July 12, 2017
Sponsor
The Catholic University of Korea
Collaborators
AstraZeneca, Severance Hospital, Eulji General Hospital, Kyung Hee University Hospital at Gangdong
1. Study Identification
Unique Protocol Identification Number
NCT02459353
Brief Title
Effect of Dapagliflozin on Glycemic Variability
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
AstraZeneca, Severance Hospital, Eulji General Hospital, Kyung Hee University Hospital at Gangdong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
dapagliflozin, glucose variability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dapagliflozin 10mg
Arm Type
Experimental
Arm Description
a group which treated with dapagliflozin 10mg plus basal insulin therapy
Arm Title
placebo 10mg
Arm Type
Placebo Comparator
Arm Description
a group which treated with dapagliflozin placebo plus basal insulin therapy
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Glycemic Variability (mean amplitude of glycemic excursion)
Description
MAGE(mean amplitude of glycemic excursion)
Time Frame
baseline and 12 weeks
Title
Glycemic Variability (Coefficient of Variation)
Description
CV (Coefficient of Variation)
Time Frame
baseline and 12 weeks
Title
Glycemic Variability (Standard Deviation)
Description
SD (Standard Deviation)
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
glycemic control variables HbA1C
Description
HbA1C
Time Frame
baseline and each visit(6weeks, 12weeks)
Title
glycemic control variables Fasting Plasma Glucose
Description
Fasting Plasma Glucose
Time Frame
baseline and each visit(6weeks, 12weeks)
Title
lipid profile Total cholesterol
Description
Total cholesterol
Time Frame
baseline and each visit(6weeks, 12weeks)
Title
lipid profile Triglyceride
Description
Triglyceride
Time Frame
baseline and each visit(6weeks, 12weeks)
Title
lipid profile HDL-cholesterol
Description
HDL-cholesterol
Time Frame
baseline and each visit(6weeks, 12weeks)
Title
lipid profile LDL-cholesterol
Description
LDL-cholesterol
Time Frame
baseline and each visit(6weeks, 12weeks)
Title
glycemic control variables Percentage of patients achieving HbA1c < 7%
Description
Percentage of patients achieving HbA1c < 7%
Time Frame
12weeks
Title
glycemic control variables Percentage of patients achieving HbA1c < 6.5%
Description
Percentage of patients achieving HbA1c < 6.5%
Time Frame
12weeks
Title
glycemic control variables 24hr urinary glucose excretion
Description
24hr urinary glucose excretion
Time Frame
baseline and 12weeks
Title
glycemic control variables Changes in insulin dose
Description
Changes in insulin dose
Time Frame
baseline and each visit(6weeks, 12weeks)
Title
blood pressure SBP
Description
SBP
Time Frame
baseline and each visit(6weeks, 12weeks)
Title
blood pressure DBP
Description
DBP
Time Frame
baseline and each visit(6weeks, 12weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female and male aged 20~70 years
Type 2 diabetes patients
Treatment on basal insulin therapy ≥0.2U/kg/day(±metformin and/or ±sulfonylurea) for at least 12 weeks
Inadequate glycemic control ; HbA1c 7.0%~10.0% at screening
Female of childbearing potential agrees to routinely use of adequate contraception from signing of the informed consent throughout the duration of the study
Understands the study procedure, alternatives, and risks and voluntarily agrees to participated by giving written informed consent
Exclusion Criteria:
Type 1 diabetes(Fasting C-peptide ≤ 0.78ng/dL(or 0.26 nM/L)), secondary diabetes, gestational diabetes
Insulin therapy modalities containing short or rapid acting insulin (continuous subcutaneous insulin injection, pre-mixed insulin, basal-bolus insulin)
History of diabetic ketoacidosis, hyperglycemic hyperosmolar state
Estimated glomerular filtration rate <60 mL/min/1.73 m2
History of chronic cystitis or recurrent urinary tract infection
Currently on loop diuretics
Adrenal insufficiency, pituitary insufficiency
Currently on medication known to affect glucose metabolism (e.g. corticosteroids, immunosuppressants)
Hemoglobin <10g/dL in female, <12g/dL in male
Abnormal liver function (AST/ALT > x3 upper normal limit)
On weight loss program or taking weight loss medication
NYHA class III, IV congestive heart failure
History of acute myocardial infarction, unstable angina, coronary artery bypass graft or stroke within 6 months
History of bladder cancer
History of malignancy within 5 years
Pregnant or lactating women
History of excessive alcohol abuse (≥30g/day)
Hypersensitivity to SGLT2 inhibitors
Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Subject who the investigator deems inappropriate to participate in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun-Ho Yoon, Ph.D.
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St.Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Dapagliflozin on Glycemic Variability
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