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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00680745
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: dapagliflozin Drug: Glimepiride Drug: metformin hydrochloride Drug: pioglitazone hydrochloride Drug: Rosiglitazone Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 597 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2008
Primary Completion Date : November 2009
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: 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 Name: Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: 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 Name: Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Avandia
Placebo Comparator: 4
Placebo + Glimepiride
Drug: Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Other Name: Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Avandia


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680745


  Show 66 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Principal Investigator: Krzysztof Strojek, Prof. Dr. Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00680745     History of Changes
Other Study ID Numbers: D1690C00005
First Posted: May 20, 2008    Key Record Dates
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013
Last Verified: August 2013

Keywords provided by AstraZeneca:
Dapagliflozin
efficacy
safety
sulphonylurea
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Glimepiride
Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors