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CompletedNCT02459353DIVEUpdated Jul 13, 2017

Effect of Dapagliflozin on Glycemic Variability

A Phase 4 interventional study of Dapagliflozin and Placebo in Type 2 Diabetes Mellitus, sponsored by The Catholic University of Korea. Completed at 1 site in South Korea. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-07-13.

Sponsored by The Catholic University of Korea · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • dapagliflozin
  • glucose variability
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 86 is close to the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

The Catholic University of Korea is the lead sponsor of 155 studies on the registry; 4 are open to participants now.

Browse The Catholic University of Korea studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    dapagliflozin 10mg

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

    Drug: Dapagliflozin

  • Placebo comparator
    placebo 10mg

    a group which treated with dapagliflozin placebo plus basal insulin therapy

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Glycemic Variability (mean amplitude of glycemic excursion)

    MAGE(mean amplitude of glycemic excursion)

    Time frame: baseline and 12 weeks

  2. Glycemic Variability (Coefficient of Variation)

    CV (Coefficient of Variation)

    Time frame: baseline and 12 weeks

  3. Glycemic Variability (Standard Deviation)

    SD (Standard Deviation)

    Time frame: baseline and 12 weeks

Secondary outcomes

  1. glycemic control variables HbA1C

    HbA1C

    Time frame: baseline and each visit(6weeks, 12weeks)

  2. glycemic control variables Fasting Plasma Glucose

    Fasting Plasma Glucose

    Time frame: baseline and each visit(6weeks, 12weeks)

  3. lipid profile Total cholesterol

    Total cholesterol

    Time frame: baseline and each visit(6weeks, 12weeks)

  4. lipid profile Triglyceride

    Triglyceride

    Time frame: baseline and each visit(6weeks, 12weeks)

  5. lipid profile HDL-cholesterol

    HDL-cholesterol

    Time frame: baseline and each visit(6weeks, 12weeks)

  6. lipid profile LDL-cholesterol

    LDL-cholesterol

    Time frame: baseline and each visit(6weeks, 12weeks)

  7. glycemic control variables Percentage of patients achieving HbA1c < 7%

    Percentage of patients achieving HbA1c \< 7%

    Time frame: 12weeks

  8. glycemic control variables Percentage of patients achieving HbA1c < 6.5%

    Percentage of patients achieving HbA1c \< 6.5%

    Time frame: 12weeks

  9. glycemic control variables 24hr urinary glucose excretion

    24hr urinary glucose excretion

    Time frame: baseline and 12weeks

  10. glycemic control variables Changes in insulin dose

    Changes in insulin dose

    Time frame: baseline and each visit(6weeks, 12weeks)

  11. blood pressure SBP

    SBP

    Time frame: baseline and each visit(6weeks, 12weeks)

  12. blood pressure DBP

    DBP

    Time frame: baseline and each visit(6weeks, 12weeks)

07

Study locations

1 site
  • Seoul St.Mary's Hospital
    Seoul, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02459353
Lead sponsor
The Catholic University of Korea
Collaborators
AstraZeneca, Severance Hospital, Eulji General Hospital, Kyung Hee University Hospital at Gangdong
Responsible party
Kun-Ho Yoon (Professor of endocrinology division, Department of Internal Medicine, The Catholic University of Korea) — Principal investigator
First posted
Jun 2, 2015
Start date
Aug 2015
Primary completion
Dec 2016
Completion
May 2017
Last update
Jul 13, 2017

Study contacts

Kun-Ho Yoon, Ph.D.
principal investigator · Seoul St. Mary's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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