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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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