Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

August 9, 2013 updated by: AstraZeneca

A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone

This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

597

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

  • Czech Republic
      • Blansko, Czech Republic
        • Research Site
      • Breclav, Czech Republic
        • Research Site
      • Bruntal, Czech Republic
        • Research Site
      • Hodonin, Czech Republic
        • Research Site
      • Ostrava - Belsky Les, Czech Republic
        • Research Site
      • Plzen, Czech Republic
        • Research Site
      • Praha 1, Czech Republic
        • Research Site
      • Pribram Viii, Czech Republic
        • Research Site
      • Rakovnik, Czech Republic
        • Research Site
      • Semily, Czech Republic
        • Research Site
  • Hungary
      • Balatonfured, Hungary
        • Research Site
      • Bekescsaba, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Csongrad, Hungary
        • Research Site
      • Eger, Hungary
        • Research Site
      • Gyongyos, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Mako, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Mosonmagyarovar, Hungary
        • Research Site
      • Siofok, Hungary
        • Research Site
      • Szentes, Hungary
        • Research Site
      • TAT, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Research Site
      • Incheon, Korea, Republic of
        • Research Site
      • Seongnam, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
      • Uljeongbu, Korea, Republic of
        • Research Site
    • Chonbuk
      • Jeonju, Chonbuk, Korea, Republic of
        • Research Site
    • Kangwon-do
      • Wonju, Kangwon-do, Korea, Republic of
        • Research Site
    • Kyunggi-do
      • Suwon, Kyunggi-do, Korea, Republic of
        • Research Site
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
      • Marikina City, Philippines
        • Research Site
      • Pasig City, Philippines
        • Research Site
  • Poland
      • Bielsko - Biala, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Chojnice, Poland
        • Research Site
      • Chrzanow, Poland
        • Research Site
      • Ciechocinek, Poland
        • Research Site
      • Czechowice-Dziedzice, Poland
        • Research Site
      • Elblag, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Gniewkowo, Poland
        • Research Site
      • Grudziadz, Poland
        • Research Site
      • Ilawa, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Mragowo, Poland
        • Research Site
      • Plock, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Ruda Slaska, Poland
        • Research Site
      • Sopot, Poland
        • Research Site
      • Torun, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
      • Zabrze, Poland
        • Research Site
      • Zielona Gora, Poland
        • Research Site
      • Zory, Poland
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
  • Ukraine
      • Dnipropetrov'sk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kiev, Ukraine
        • Research Site
      • Vinnytsia, 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes
  • Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
  • Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%

Exclusion Criteria:

  • Type 1 Diabetes
  • Hepatic (liver) impairment
  • 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 2.5mg + Glimepiride
Drug: dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Drug: Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Other Names:
  • Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Avandia
Experimental: 2
dapagliflozin 5mg + Glimepiride
Drug: dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Drug: Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Other Names:
  • Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Avandia
Experimental: 3
dapagliflozin 10mg + Glimepiride
Drug: dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Drug: Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Other Names:
  • Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Avandia
Placebo Comparator: 4
Placebo + Glimepiride
Drug: Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Other Names:
  • Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Names:
  • Avandia

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 assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.
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 show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.
Baseline to Week 24
Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise
Time Frame: Baseline to Week 24
To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.
Baseline to Week 24
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Time Frame: At Week 24
To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride.
At Week 24
Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2
Time Frame: Baseline to Week 24
To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.
Baseline to Week 24
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
Time Frame: Baseline to Week 24
To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.
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: Krzysztof Strojek, Prof. Dr., Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland

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

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

April 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (Estimate)

May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

October 14, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1690C00005

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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