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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00680745
First received: May 16, 2008
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: dapagliflozin
Drug: Glimepiride
Drug: metformin hydrochloride
Drug: pioglitazone hydrochloride
Drug: Rosiglitazone
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,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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Adjusted Mean Change in Body Weight [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
    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.

  • Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Adjusted Mean Change in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.


Enrollment: 597
Study Start Date: April 2008
Study Completion Date: May 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
dapagliflozin 2.5mg + Glimepiride
Drug: dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Drug: Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Other Name: Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Avandia
Experimental: 2
dapagliflozin 5mg + Glimepiride
Drug: dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Drug: Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Other Name: Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Avandia
Experimental: 3
dapagliflozin 10mg + Glimepiride
Drug: dapagliflozin
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Drug: Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Other Name: Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Avandia
Placebo Comparator: 4
Placebo + Glimepiride
Drug: Glimepiride
tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks
Other Name: Amaryl
Drug: metformin hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Glucophage
Drug: pioglitazone hydrochloride
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Actos
Drug: Rosiglitazone
rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
Other Name: Avandia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680745

  Show 66 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Principal Investigator: Krzysztof Strojek, Prof. Dr. Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00680745     History of Changes
Other Study ID Numbers: D1690C00005
Study First Received: May 16, 2008
Results First Received: April 13, 2011
Last Updated: August 9, 2013
Health Authority: Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
India: Ministry of Health
Korea: Food and Drug Administration
Philippines: Bureau of Food and Drugs
Poland: Ministry of Health
Thailand: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:
Dapagliflozin
efficacy
safety
sulphonylurea
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Pioglitazone
Rosiglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014