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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014