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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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01392677
First received: July 11, 2011
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
High HbA1c Level
Inadequate Glycaemic Control
Drug: dapagliflozin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adjusted Mean Change From Baseline in HbA1c Levels [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    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:
  • Adjusted Mean Change From Baseline in FPG [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo

  • Adjusted Mean Change From Baseline in Total Body Weight [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo

  • Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF) [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo

  • Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure [ Time Frame: Baseline to week 8 ] [ Designated as safety issue: No ]
    To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo


Enrollment: 311
Study Start Date: October 2011
Study Completion Date: August 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392677

  Hide Study Locations
Locations
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, Czech Republic
Research Site
Praha 5, Czech Republic
Research Site
Praha 6, 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
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:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01392677     History of Changes
Other Study ID Numbers: D1693C00005
Study First Received: July 11, 2011
Results First Received: November 5, 2013
Last Updated: February 11, 2014
Health Authority: Canada: Health Canada
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
dapagliflozin
diabetes
hyperglycaemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 19, 2014