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

Official 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.”

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.

Intervention(s) in this Clinical Trial

• Drug: dapagliflozin
  • Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
• Drug: glipizide
  • Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
• Drug: metformin hydrochloride
  • Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • dapagliflozin plus metformin
• Active Comparator: 2
  • glipizide plus metformin

Primary Measures

• To examine whether the absolute change from baseline in HbA1c level with dapagliflozin plus metformin is non-inferior to glipizide plus metformin in patients with type 2 diabetes who have inadequate glycaemic control on metformin therapy alone
  • Time Frame: 52 weeks
    Safety Issue?: No

Secondary Measures

• To show that dapagliflozin plus metformin reduces body weight compared to glipizide plus metformin
  • Time Frame: after 52 weeks treatment
    Safety Issue?: No
• To show that dapagliflozin plus metformin treatment leads to fewer patients with hypoglycaemic events compared to glipizide plus metformin
  • Time Frame: after 52 weeks of treatment
    Safety Issue?: Yes
• To show that a higher percentage of patients treated with dapagliflozin plus metformin reduce their baseline body weight with at least 5% compared to patients treated with glipizide plus metformin after 52 weeks of treatment.
  • Time Frame: after 52 weeks of treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Michael A. Nauck, Prof. Dr. med. Principal Investigator Diabeteszentrum Bad Lauterberg, Germany  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00660907

Study ID Number: D1690C00004

ClinicalTrials.gov Identifier: NCT00660907

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica