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Completed

NCT Number: NCT00680745

Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

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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, Blansko, Czechia

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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
  • Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
  • Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%

Exclusion criteria

  • Type 1 Diabetes
  • Hepatic (liver) impairment
  • Renal (kidney) failure or dysfunction

Treatment and study plan

Dapagliflozin

Drug

tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks

Glimepiride

Drug

tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks

Other names: Amaryl

Metformin Hydrochloride

Drug

rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Other names: Glucophage

pioglitazone hydrochloride

Drug

rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Other names: Actos

rosiglitazone

Drug

rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Other names: Avandia

Primary outcomes

  1. Adjusted Mean Change in HbA1c Levels

    Time frame: Baseline to Week 24

    To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.

Secondary outcomes

  1. Adjusted Mean Change in Body Weight

    Time frame: Baseline to Week 24

    To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.

  2. Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise

    Time frame: Baseline to Week 24

    To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.

  3. Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

    Time frame: At Week 24

    To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c < 7% after 24 weeks of treatment, compared to placebo plus glimepiride.

  4. Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2

    Time frame: Baseline to Week 24

    To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.

  5. Adjusted Mean Change in Fasting Plasma Glucose (FPG)

    Time frame: Baseline to Week 24

    To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
May 20, 2008
Registry last updated
Oct 14, 2013

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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