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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 is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01392677
First received: July 11, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c from baseline to week 24 [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose from baseline to week 24 [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in total body weight from baseline to week 24 [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving a therapeutic glycaemic response, defined as HbA1c <7.0% at week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change in seated systolic blood pressure (SBP) from baseline to week 8 [ Time Frame: from baseline to week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 219
Study Start Date: October 2011
Estimated Study Completion Date: September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392677

  Show 38 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Eva Johnsson, MD, PhD AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden
Principal Investigator: Stephan Matthaei, Prof.Dr.med Diabetes-Zentrum Quakenbruck
  More 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
Last Updated: May 13, 2013
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013