NCT02459353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

May 26, 2015

Last Update Submit

July 12, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

dapagliflozinglucose variability

Outcome Measures

Primary Outcomes (3)

  • Glycemic Variability (mean amplitude of glycemic excursion)

    MAGE(mean amplitude of glycemic excursion)

    baseline and 12 weeks

  • Glycemic Variability (Coefficient of Variation)

    CV (Coefficient of Variation)

    baseline and 12 weeks

  • Glycemic Variability (Standard Deviation)

    SD (Standard Deviation)

    baseline and 12 weeks

Secondary Outcomes (12)

  • glycemic control variables HbA1C

    baseline and each visit(6weeks, 12weeks)

  • glycemic control variables Fasting Plasma Glucose

    baseline and each visit(6weeks, 12weeks)

  • lipid profile Total cholesterol

    baseline and each visit(6weeks, 12weeks)

  • lipid profile Triglyceride

    baseline and each visit(6weeks, 12weeks)

  • lipid profile HDL-cholesterol

    baseline and each visit(6weeks, 12weeks)

  • +7 more secondary outcomes

Study Arms (2)

dapagliflozin 10mg

EXPERIMENTAL

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

Drug: Dapagliflozin

placebo 10mg

PLACEBO COMPARATOR

a group which treated with dapagliflozin placebo plus basal insulin therapy

Drug: Placebo

Interventions

DapagliflozinDRUG
dapagliflozin 10mg
PlaceboDRUG
placebo 10mg

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kun-Ho Yoon, Ph.D.

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of endocrinology division, Department of Internal Medicine

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 2, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

KR(1)