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Completed

NCT Number: NCT01392677

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 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders High HbA1c Level Hyperglycemia Inadequate Glycaemic Control Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period

Placebo

Drug

matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2011
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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