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Type 2 Diabetes MellitusPhase 4DIVENCT02459353

Effect of Dapagliflozin on Glycemic Variability

A Phase 4 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by The Catholic University of Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Dapagliflozin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteSouth Korea
Study dates
Aug 2015to May 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul St.Mary's Hospital

    Seoul

Other trials in South Korea

About this study

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

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.

Being tested
Dapagliflozin, Placebo
Keywords
dapagliflozin, glucose variability
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02459353
Study groupRoleWhat they receive
dapagliflozin 10mgExperimentala group which treated with dapagliflozin 10mg plus basal insulin therapy
Receives: Drug: Dapagliflozin
placebo 10mgPlacebo comparatora group which treated with dapagliflozin placebo plus basal insulin therapy
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic Variability (mean amplitude of glycemic excursion)

    MAGE(mean amplitude of glycemic excursion)

    Measured: baseline and 12 weeks

  2. Glycemic Variability (Coefficient of Variation)

    CV (Coefficient of Variation)

    Measured: baseline and 12 weeks

  3. Glycemic Variability (Standard Deviation)

    SD (Standard Deviation)

    Measured: baseline and 12 weeks

Secondary outcomes (12)

  1. glycemic control variables HbA1C

    HbA1C

    Measured: baseline and each visit(6weeks, 12weeks)

  2. glycemic control variables Fasting Plasma Glucose

    Fasting Plasma Glucose

    Measured: baseline and each visit(6weeks, 12weeks)

  3. lipid profile Total cholesterol

    Total cholesterol

    Measured: baseline and each visit(6weeks, 12weeks)

  4. lipid profile Triglyceride

    Triglyceride

    Measured: baseline and each visit(6weeks, 12weeks)

  5. lipid profile HDL-cholesterol

    HDL-cholesterol

    Measured: baseline and each visit(6weeks, 12weeks)

  6. lipid profile LDL-cholesterol

    LDL-cholesterol

    Measured: baseline and each visit(6weeks, 12weeks)

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

    Percentage of patients achieving HbA1c < 7%

    Measured: 12weeks

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

    Percentage of patients achieving HbA1c < 6.5%

    Measured: 12weeks

  9. glycemic control variables 24hr urinary glucose excretion

    24hr urinary glucose excretion

    Measured: baseline and 12weeks

  10. glycemic control variables Changes in insulin dose

    Changes in insulin dose

    Measured: baseline and each visit(6weeks, 12weeks)

  11. blood pressure SBP

    SBP

    Measured: baseline and each visit(6weeks, 12weeks)

  12. blood pressure DBP

    DBP

    Measured: baseline and each visit(6weeks, 12weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2016
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02459353
Sponsor's protocol ID
ISSDAPA0006
Acronym
DIVE
Status last verified
Jul 2017
First submitted
26 May 2015
Last updated
13 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin in people with Type 2 Diabetes Mellitus, run by The Catholic University of Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic Variability (mean amplitude of glycemic excursion) (time frame: baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02459353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.

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