Dapagliflozin DPPIV Inhibitor add-on Study

June 9, 2014 updated by: AstraZeneca

A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin

This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

833

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
      • Caba, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Salta, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina
        • Research Site
      • La Plata, Buenos Aires, Argentina
        • Research Site
      • Lanus, Buenos Aires, Argentina
        • Research Site
      • Mar Del Plata, Buenos Aires, Argentina
        • Research Site
      • Moron, Buenos Aires, Argentina
        • Research Site
    • Caba
      • Buenos Aires, Caba, Argentina
        • Research Site
  • Germany
      • Bad Nauheim, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Meissen, Germany
        • Research Site
      • Munster, Germany
        • Research Site
      • Pirna, Germany
        • Research Site
      • Wangen, Germany
        • Research Site
  • Mexico
    • DF
      • Mexico, DF, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
  • Poland
      • Ciechocinek, Poland
        • Research Site
      • Czechowice-dziedzice, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Gniewkowo, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Krotoszyn, Poland
        • Research Site
      • Leczyca, Poland
        • Research Site
      • Mragowo, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Sopot, Poland
        • Research Site
      • Torun, Poland
        • Research Site
      • Zabrze, Poland
        • Research Site
  • United Kingdom
      • Bath, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Blackpool, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Harrow, United Kingdom
        • Research Site
    • Lancs
      • Bolton, Lancs, United Kingdom
        • Research Site
    • Leicester
      • Burbage, Leicester, United Kingdom
        • Research Site
    • Middlesex
      • Sunbury on Thames, Middlesex, United Kingdom
        • Research Site
    • Peterborough
      • Wansford, Peterborough, United Kingdom
        • Research Site
    • Sheffield
      • Ecclesfield, Sheffield, United Kingdom
        • Research Site
    • Surrey
      • Addlestone, Surrey, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States
        • Research Site
      • Ozark, Alabama, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Chula Vista, California, United States
        • Research Site
      • Greenbrae, California, United States
        • Research Site
      • Laguna Hills, California, United States
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Riverside, California, United States
        • Research Site
      • West Hills, California, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
      • Deland, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Longwood, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Port Orange, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Georgia
      • Stone Mountain, Georgia, United States
        • Research Site
    • Kansas
      • Wichita, Kansas, United States
        • Research Site
    • Louisiana
      • Lake Charles, Louisiana, United States
        • Research Site
    • Minnesota
      • Edina, Minnesota, United States
        • Research Site
    • Missouri
      • St Louis, Missouri, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
      • Pahrump, Nevada, United States
        • Research Site
    • New York
      • Staten Island, New York, United States
        • Research Site
    • North Carolina
      • Wilmington, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Columbus, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Medord, Oregon, United States
        • Research Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States
        • Research Site
      • Myrtle Beach, South Carolina, United States
        • Research Site
      • Simpsonville, South Carolina, United States
        • Research Site
    • Tennessee
      • Bristol, Tennessee, United States
        • Research Site
    • Texas
      • Corpus Christi, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • North Richland Hills, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Virginia
      • Burke, Virginia, United States
        • Research Site
      • Manassas, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
    • Washington
      • Lakewood, Washington, United States
        • 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:

  • Patients with type 2 diabetes
  • Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
  • Patients will be screened by a blood test and only those who need additional therapy can be enrolled

Exclusion Criteria:

  • Patients with type 1 diabetes
  • Patients with very poorly controlled diabetes
  • Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Dapagliflozin 10 mg tablet
Drug: Dapagliflozin
10 mg tablet, oral, once daily, 48 weeks
Placebo Comparator: 2
Matching placebo tablet
Drug: Placebo
Matching placebo tablet

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 24
To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change in Body Weight
Time Frame: Baseline to Week 24
To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.
Baseline to Week 24
Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%
Time Frame: Baseline to Week 24
To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.
Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
Time Frame: Baseline to Week 24
To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.
Baseline to Week 24
Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg
Time Frame: Baseline to Week 8
To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8.
Baseline to Week 8
Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise
Time Frame: Baseline to Week 24
To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.
Baseline to Week 24
Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline
Time Frame: Baseline to Week 24
To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.
Baseline to Week 24

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: Serge Jabbour, MD, Thomas Jefferson University, Philadelphia

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, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

September 23, 2009

First Submitted That Met QC Criteria

September 24, 2009

First Posted (Estimate)

September 25, 2009

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

June 9, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1690C00010

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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