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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

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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:
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : January 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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

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 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

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


  Show 47 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01392677     History of Changes
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs