Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

August 9, 2013 updated by: AstraZeneca

A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 3

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

  • Bulgaria
      • Blagoevgrad, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Czech Republic
      • Beroun, Czech Republic
        • Research Site
      • Brno, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
      • Semily, Czech Republic
        • Research Site
      • Slany, Czech Republic
        • Research Site
  • Hungary
      • Balatonfured, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Csongrad, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • TAT, Hungary
        • Research Site
  • Poland
      • Elblag, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Torun, Poland
        • Research Site
  • Sweden
      • Goteborg, Sweden
        • Research Site
      • Jarfalla, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Malmo, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site

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

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment
  • Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%
  • ≥30 years for males
  • ≥55 years for females

Exclusion Criteria:

  • Type 1 Diabetes
  • Body weight change >5% within 3 months prior to enrolment
  • Renal and liver impairment

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Dapagliflozin 10 mg plus Metformin
Drug: Dapagliflozin
Tablet oral 10 mg total daily dose once daily 102 weeks
Drug: Metformin
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
Drug: Sitagliptin
Tablet oral 100 mg total daily dose once daily rescue medication
Placebo Comparator: B
Placebo plus Metformin
Drug: Metformin
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
Drug: Sitagliptin
Tablet oral 100 mg total daily dose once daily rescue medication
Drug: Placebo
Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change in Total Body Weight
Time Frame: Baseline to Week 24
To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change in Waist Circumference
Time Frame: Baseline to Week 24
To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference.
Baseline to Week 24
Adjusted Mean Change in Body Fat Mass
Time Frame: Baseline to Week 24
To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry.
Baseline to Week 24
Proportion of Participants With Body Weight Decrease ≥5%
Time Frame: Baseline to Week 24
To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value.
Baseline to Week 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)
Time Frame: Baseline to Week 102
To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry.
Baseline to Week 102
Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Time Frame: Baseline to Week 102
To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry.
Baseline to Week 102
Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip
Time Frame: Baseline to Week 102
To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry.
Baseline to Week 102

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Jan Bolinder, MD, PhD, Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1690C00012

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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