Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

February 11, 2014 updated by: AstraZeneca

A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

311

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

  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
      • Sydney Mines, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada
        • Research Site
      • Etobicoke, Ontario, Canada
        • Research Site
      • Markham, Ontario, Canada
        • Research Site
      • Smiths Falls, Ontario, Canada
        • Research Site
    • Prince Edward Island
      • Kensington, Prince Edward Island, Canada
        • Research Site
    • Quebec
      • Laval, Quebec, Canada
        • Research Site
  • Czech Republic
      • Beroun, Czech Republic
        • Research Site
      • Ceske Budejovice, Czech Republic
        • Research Site
      • Jilove U Prahy, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
      • Praha 5, Czech Republic
        • Research Site
      • Praha 6, Czech Republic
        • Research Site
      • Semily, Czech Republic
        • Research Site
      • Vyskov, Czech Republic
        • Research Site
  • Germany
      • Asslar, Germany
        • Research Site
      • Aßlar, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Falkensee, Germany
        • Research Site
      • Neuwied, Germany
        • Research Site
      • Pirna, Germany
        • Research Site
  • Poland
      • Kielce, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Poznań, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Zgierz, Poland
        • Research Site
      • Łódź, Poland
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Povazska Bystrica, Slovakia
        • Research Site
      • Rimavska Sobota, Slovakia
        • Research Site
  • Spain
      • A Coruña, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Oviedo, Spain
        • Research Site
      • Sta Coloma de Gramenet (BCN), Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
    • Catalu?a
      • Sta Coloma de Gramanet (bcn), Catalu?a, Spain
        • Research Site
    • Cataluna
      • Barcelona, Cataluna, Spain
        • Research Site
    • Galicia
      • A Coruna, Galicia, Spain
        • 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 mellitus
  • Men or women age ≥ 18 years old
  • Stable dose combination of metformin and sulfonylurea
  • HbA1c ≥7.7% and ≤11.0%

Exclusion Criteria:

  • Type 1 diabetes mellitus or diabetes insipidus
  • Recent cardiovascular events
  • Kidney or urological disorders
  • Hepatic disorders

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: Dapagliflozin 10 mg tablet
Drug: dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
Placebo Comparator: matching placebo tablet
Drug: placebo
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change From Baseline in HbA1c Levels
Time Frame: Baseline to week 24
To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.
Baseline to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change From Baseline in FPG
Time Frame: Baseline to week 24
To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo
Baseline to week 24
Adjusted Mean Change From Baseline in Total Body Weight
Time Frame: Baseline to week 24
To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo
Baseline to week 24
Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)
Time Frame: Baseline to week 24
To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo
Baseline to week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure
Time Frame: Baseline to week 8
To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo
Baseline to week 8

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Eva Johnsson, PhD, Medical Science Director, AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden
  • Principal Investigator: Stephan Matthaei, Prof.Dr.med, Diabetes-Zentrum Quakenbruck

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

October 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

March 12, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1693C00005

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.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on dapagliflozin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe