Evaluation of Dapagliflozin Taken Twice-daily

October 16, 2014 updated by: AstraZeneca

A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy

This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

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

  • Germany
      • Asslar, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Biberach A.d. Riss, Germany
        • Research Site
      • Bosenheim, Germany
        • Research Site
      • Dippoldiswalde, Germany
        • Research Site
      • Falkensee, Germany
        • Research Site
      • Meissen, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Neuwied, Germany
        • Research Site
      • Pirna, Germany
        • Research Site
      • Wahlstedt, Germany
        • Research Site
  • Hungary
      • Balatonfured, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Csongrad, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Gyongyos, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Mako, Hungary
        • Research Site
      • Nyiregyhaza, Hungary
        • Research Site
      • TAT, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
  • Romania
      • Brasov, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Sibiu, Romania
        • Research Site
      • Suceava, Romania
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Research Site
      • Bratislava, Slovakia
        • Research Site
      • Dolny Kubin, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Lucenec, Slovakia
        • Research Site
      • Namestovo, Slovakia
        • Research Site
      • Piestany, Slovakia
        • Research Site
      • Prievidza, Slovakia
        • Research Site
      • Rimavska Sobota, Slovakia
        • Research Site
      • Ruzomberok, Slovakia
        • Research Site
      • Zilina, Slovakia
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Umkomaas, South Africa
        • Research Site
    • Kwa Zulu Natal
      • Verulam, Kwa Zulu Natal, South Africa
        • Research Site
  • Switzerland
      • Basel, Switzerland
        • Research Site
      • Bern, Switzerland
        • Research Site
      • Geneva 14, Switzerland
        • Research Site
      • Kreuzlingen, Switzerland
        • Research Site
      • Lugano, Switzerland
        • Research Site
      • Rorschach, Switzerland
        • Research Site
    • Graubunden
      • Chur, Graubunden, Switzerland
        • Research Site
  • Ukraine
      • Dnipropetrov'sk, Ukraine
        • Research Site
      • Kiev, Ukraine
        • Research Site
      • Vinnytsia, Ukraine
        • Research Site
      • Vynnitsa, Ukraine
        • Research Site
      • Zaporozhye, Ukraine
        • 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 to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Diagnosis of T2DM
  • Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy >/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
  • HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.

Exclusion Criteria:

  • Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus
  • History of diabetic ketoacidosis
  • Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
  • FPG >270 mg/dL (>15.0 mmol/L)
  • BMI >45 kg/m2

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 2.5 mg twice-daily plus open-label metformin
Drug: dapagliflozin
2.5 mg tablet, taken orally, twice daily
Drug: dapagliflozin
5 mg tablet taken orally, twice daily
Drug: dapagliflozin
10 mg tablet taken orally, once daily
Drug: metformin
>/= 1500 mg total daily dose, tablets taken orally, twice daily
Experimental: 2
Dapagliflozin 5.0 mg twice-daily plus open-label metformin
Drug: dapagliflozin
2.5 mg tablet, taken orally, twice daily
Drug: dapagliflozin
5 mg tablet taken orally, twice daily
Drug: dapagliflozin
10 mg tablet taken orally, once daily
Drug: metformin
>/= 1500 mg total daily dose, tablets taken orally, twice daily
Experimental: 3
Dapagliflozin 10 mg once-daily plus open-label metformin
Drug: dapagliflozin
2.5 mg tablet, taken orally, twice daily
Drug: dapagliflozin
5 mg tablet taken orally, twice daily
Drug: dapagliflozin
10 mg tablet taken orally, once daily
Drug: metformin
>/= 1500 mg total daily dose, tablets taken orally, twice daily
Placebo Comparator: 4
Placebo plus open-label metformin
Drug: placebo
placebo
Drug: metformin
>/= 1500 mg total daily dose, tablets taken orally, twice daily

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 16
To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Percent Change in Body Weight
Time Frame: Baseline to Week 16
To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Baseline to Week 16
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1
Time Frame: Baseline to Week 1
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.
Baseline to Week 1
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
Time Frame: Baseline to Week 16
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Baseline to Week 16
Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.
Time Frame: Baseline to Week 16
To compare the adjusted proportions controlling for baseline HbA1c [acc. to Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu] of participants with HbA1c <7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.
Baseline to Week 16

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: Shamik Parikh, AstraZeneca

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

November 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 16, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1691C00003

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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