Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

March 10, 2015 updated by: AstraZeneca

A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1217

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

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Caba, Argentina
        • Research Site
      • Capital Federal, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Corrientes, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
      • La Plata, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
  • France
      • L'aigle, France
        • Research Site
      • Murs Erigne, France
        • Research Site
      • Nantes, France
        • Research Site
      • Nantes Cedex 1, France
        • Research Site
      • Paris, France
        • Research Site
      • Tours, France
        • Research Site
      • Vannes, France
        • Research Site
  • Germany
      • Bad Lauterberg, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Heilbronn, Germany
        • Research Site
      • Ludwigshafen, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Pirna, Germany
        • Research Site
      • Schmiedeberg, Germany
        • Research Site
      • Wangen, Germany
        • Research Site
  • Italy
      • Perugia, Italy
        • Research Site
      • Pisa, Italy
        • Research Site
      • Roma, Italy
        • Research Site
  • Mexico
      • Acapulco, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • México, Mexico
        • Research Site
      • Veracruz, Mexico
        • Research Site
  • Netherlands
      • Den Haag, Netherlands
        • Research Site
      • Deurne, Netherlands
        • Research Site
      • Gorinchem, Netherlands
        • Research Site
      • Groningen, Netherlands
        • Research Site
      • Lichtenvoorde (gld), Netherlands
        • Research Site
      • Losser, Netherlands
        • Research Site
      • Poortvliet, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Wildervank, Netherlands
        • Research Site
      • Zutphen, Netherlands
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Parow, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
      • Umkomaas, South Africa
        • Research Site
      • Witbank, South Africa
        • Research Site
  • Spain
      • Alicante, Spain
        • Research Site
      • Alzira (Valencia), Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Cornellá de Llobregat (BCN), Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
  • Sweden
      • Göteborg, Sweden
        • Research Site
      • Järfälla, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Malmö, Sweden
        • Research Site
      • Skene, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Södertälje, Sweden
        • Research Site
      • Umeå, Sweden
        • Research Site
  • United Kingdom
      • Addlestone, United Kingdom
        • Research Site
      • Aylesbury, United Kingdom
        • Research Site
      • Bath, United Kingdom
        • Research Site
      • Bolton, United Kingdom
        • Research Site
      • Bury St Edmonds, United Kingdom
        • Research Site
      • Cookstown, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Ecclesfield, United Kingdom
        • Research Site
      • Edinburgh, United Kingdom
        • Research Site
      • Mortimer Reading, United Kingdom
        • Research Site
      • Trowbridge, United Kingdom
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes
  • Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
  • HbA1c >6.5% and </=10%

Exclusion Criteria:

  • Type 1 Diabetes
  • Insulin therapy within one year of enrolment
  • Renal (kidney) failure or dysfunction

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
dapagliflozin plus metformin
Drug: dapagliflozin
Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
Drug: metformin hydrochloride
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Other Names:
  • Glucophage
Active Comparator: 2
glipizide plus metformin
Drug: metformin hydrochloride
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Other Names:
  • Glucophage
Drug: glipizide
Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
Other Names:
  • Glucotrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change in HbA1c Levels
Time Frame: Baseline to Week 52
To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.
Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change in Body Weight
Time Frame: Baseline to Week 52
To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.
Baseline to Week 52
Proportion of Participants With at Least One Episode of Hypoglycemia
Time Frame: Baseline to Week 52
To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.
Baseline to Week 52
Proportion of Participants With Body Weight Reduction of at Least 5%
Time Frame: Baseline to Week 52
To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.
Baseline to Week 52

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: Michael A. Nauck, Prof. Dr. med., Diabeteszentrum Bad Lauterberg, Germany

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

Helpful Links

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

March 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1690C00004

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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