Effect of Dapagliflozin on Glycemic Variability (DIVE)

July 12, 2017 updated by: Kun-Ho Yoon, The Catholic University of Korea

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic Variability (mean amplitude of glycemic excursion)
Time Frame: baseline and 12 weeks
MAGE(mean amplitude of glycemic excursion)
baseline and 12 weeks
Glycemic Variability (Coefficient of Variation)
Time Frame: baseline and 12 weeks
CV (Coefficient of Variation)
baseline and 12 weeks
Glycemic Variability (Standard Deviation)
Time Frame: baseline and 12 weeks
SD (Standard Deviation)
baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
glycemic control variables HbA1C
Time Frame: baseline and each visit(6weeks, 12weeks)
HbA1C
baseline and each visit(6weeks, 12weeks)
glycemic control variables Fasting Plasma Glucose
Time Frame: baseline and each visit(6weeks, 12weeks)
Fasting Plasma Glucose
baseline and each visit(6weeks, 12weeks)
lipid profile Total cholesterol
Time Frame: baseline and each visit(6weeks, 12weeks)
Total cholesterol
baseline and each visit(6weeks, 12weeks)
lipid profile Triglyceride
Time Frame: baseline and each visit(6weeks, 12weeks)
Triglyceride
baseline and each visit(6weeks, 12weeks)
lipid profile HDL-cholesterol
Time Frame: baseline and each visit(6weeks, 12weeks)
HDL-cholesterol
baseline and each visit(6weeks, 12weeks)
lipid profile LDL-cholesterol
Time Frame: baseline and each visit(6weeks, 12weeks)
LDL-cholesterol
baseline and each visit(6weeks, 12weeks)
glycemic control variables Percentage of patients achieving HbA1c < 7%
Time Frame: 12weeks
Percentage of patients achieving HbA1c < 7%
12weeks
glycemic control variables Percentage of patients achieving HbA1c < 6.5%
Time Frame: 12weeks
Percentage of patients achieving HbA1c < 6.5%
12weeks
glycemic control variables 24hr urinary glucose excretion
Time Frame: baseline and 12weeks
24hr urinary glucose excretion
baseline and 12weeks
glycemic control variables Changes in insulin dose
Time Frame: baseline and each visit(6weeks, 12weeks)
Changes in insulin dose
baseline and each visit(6weeks, 12weeks)
blood pressure SBP
Time Frame: baseline and each visit(6weeks, 12weeks)
SBP
baseline and each visit(6weeks, 12weeks)
blood pressure DBP
Time Frame: baseline and each visit(6weeks, 12weeks)
DBP
baseline and each visit(6weeks, 12weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Catholic University of Korea

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstraZeneca
Severance Hospital
Eulji General Hospital
Kyung Hee University Hospital at Gangdong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kun-Ho Yoon, Ph.D., Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISSDAPA0006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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