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Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

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: NCT01392677
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : December 27, 2013
Last Update Posted : March 12, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus High HbA1c Level Inadequate Glycaemic Control Drug: dapagliflozin Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea
Study Start Date : October 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dapagliflozin 10 mg tablet Drug: dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
Placebo Comparator: matching placebo tablet Drug: placebo
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period


Outcome Measures
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Primary Outcome Measures :
  1. Adjusted Mean Change From Baseline in HbA1c Levels [ Time Frame: Baseline to week 24 ]
    To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.


Secondary Outcome Measures :
  1. Adjusted Mean Change From Baseline in FPG [ Time Frame: Baseline to week 24 ]
    To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo

  2. Adjusted Mean Change From Baseline in Total Body Weight [ Time Frame: Baseline to week 24 ]
    To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo

  3. Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF) [ Time Frame: Baseline to week 24 ]
    To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo

  4. Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure [ Time Frame: Baseline to week 8 ]
    To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo


Eligibility Criteria
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Information from the National Library of Medicine

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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 mellitus
  • Men or women age ≥ 18 years old
  • Stable dose combination of metformin and sulfonylurea
  • HbA1c ≥7.7% and ≤11.0%

Exclusion Criteria:

  • Type 1 diabetes mellitus or diabetes insipidus
  • Recent cardiovascular events
  • Kidney or urological disorders
  • Hepatic disorders
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): NCT01392677


Locations
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Canada, Alberta
Research Site
Edmonton, Alberta, Canada
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Research Site
Sydney Mines, Nova Scotia, Canada
Canada, Ontario
Research Site
Brampton, Ontario, Canada
Research Site
Etobicoke, Ontario, Canada
Research Site
Markham, Ontario, Canada
Research Site
Smiths Falls, Ontario, Canada
Canada, Prince Edward Island
Research Site
Kensington, Prince Edward Island, Canada
Canada, Quebec
Research Site
Laval, Quebec, Canada
Canada
Research Site
Quebec, Canada
Czech Republic
Research Site
Beroun, Czech Republic
Research Site
Ceske Budejovice, Czech Republic
Research Site
Jilove U Prahy, Czech Republic
Research Site
Praha 5, Czech Republic
Research Site
Praha 6, Czech Republic
Research Site
Praha, Czech Republic
Research Site
Semily, Czech Republic
Research Site
Vyskov, Czech Republic
Germany
Research Site
Asslar, Germany
Research Site
Aßlar, Germany
Research Site
Berlin, Germany
Research Site
Dresden, Germany
Research Site
Falkensee, Germany
Research Site
Neuwied, Germany
Research Site
Pirna, Germany
Poland
Research Site
Kielce, Poland
Research Site
Lodz, Poland
Research Site
Lublin, Poland
Research Site
Poznan, Poland
Research Site
Poznań, Poland
Research Site
Warszawa, Poland
Research Site
Zgierz, Poland
Research Site
Łódź, Poland
Slovakia
Research Site
Banska Bystrica, Slovakia
Research Site
Kosice, Slovakia
Research Site
Povazska Bystrica, Slovakia
Research Site
Rimavska Sobota, Slovakia
Spain
Research Site
Oviedo, Asturias, Spain
Research Site
Sta Coloma de Gramanet (bcn), Catalu?a, Spain
Research Site
Barcelona, Cataluna, Spain
Research Site
A Coruna, Galicia, Spain
Research Site
A Coruña, Spain
Research Site
Barcelona, Spain
Research Site
Oviedo, Spain
Research Site
Sta Coloma de Gramenet (BCN), Spain
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
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Study Director: Eva Johnsson, PhD, Medical Science Director AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden
Principal Investigator: Stephan Matthaei, Prof.Dr.med Diabetes-Zentrum Quakenbruck
More Information
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Additional Information:

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

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01392677    
Other Study ID Numbers: D1693C00005
First Posted: July 12, 2011    Key Record Dates
Results First Posted: December 27, 2013
Last Update Posted: March 12, 2014
Last Verified: February 2014
Keywords provided by AstraZeneca:
dapagliflozin
diabetes
hyperglycaemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs