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Efficacy and Safety of Dapagliflozin in Combination With Metformin 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: NCT00660907
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : August 23, 2013
Last Update Posted : March 30, 2015
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
dapagliflozin plus metformin
 Drug: dapagliflozin
Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks

Drug: metformin hydrochloride
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Other Name: Glucophage
Active Comparator: 2
glipizide plus metformin
 Drug: glipizide
Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
Other Name: Glucotrol

Drug: metformin hydrochloride
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks
Other Name: Glucophage


Outcome Measures
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Primary Outcome Measures :
  1. Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 52 ]
    To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.


Secondary Outcome Measures :
  1. Adjusted Mean Change in Body Weight [ Time Frame: Baseline to Week 52 ]
    To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.

  2. Proportion of Participants With at Least One Episode of Hypoglycemia [ Time Frame: Baseline to Week 52 ]
    To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.

  3. Proportion of Participants With Body Weight Reduction of at Least 5% [ Time Frame: Baseline to Week 52 ]
    To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.


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

Inclusion Criteria:

  • Type 2 Diabetes
  • Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
  • HbA1c >6.5% and </=10%

Exclusion Criteria:

  • Type 1 Diabetes
  • Insulin therapy within one year of enrolment
  • Renal (kidney) failure or dysfunction
Contacts and Locations
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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): NCT00660907


Locations
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Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
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Principal Investigator: Michael A. Nauck, Prof. Dr. med. Diabeteszentrum Bad Lauterberg, Germany
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00660907    
Other Study ID Numbers: D1690C00004
First Posted: April 17, 2008    Key Record Dates
Results First Posted: August 23, 2013
Last Update Posted: March 30, 2015
Last Verified: March 2015
Keywords provided by AstraZeneca:
Dapagliflozin
efficacy
safety
metformin
Type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
 Dapagliflozin
Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action