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Completed

NCT Number: NCT00660907

Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders 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, Buenos Aires, Argentina

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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
  • Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
  • HbA1c >6.5% and </=10%

Exclusion criteria

  • Type 1 Diabetes
  • Insulin therapy within one year of enrolment
  • Renal (kidney) failure or dysfunction

Treatment and study plan

Dapagliflozin

Drug

Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks

Glipizide

Drug

Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks

Other names: Glucotrol

Metformin Hydrochloride

Drug

Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks

Other names: Glucophage

Primary outcomes

  1. Adjusted Mean Change in HbA1c Levels

    Time frame: Baseline to Week 52

    To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.

Secondary outcomes

  1. Adjusted Mean Change in Body Weight

    Time frame: Baseline to Week 52

    To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.

  2. Proportion of Participants With at Least One Episode of Hypoglycemia

    Time frame: Baseline to Week 52

    To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.

  3. Proportion of Participants With Body Weight Reduction of at Least 5%

    Time frame: Baseline to Week 52

    To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

Important dates

Study start
2008
Primary completion
2009
Study completion
2013
First posted
Apr 17, 2008
Registry last updated
Mar 30, 2015

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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