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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2010

Intervention(s) in this Clinical Trial

• 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
• Drug: metformin hydrochloride
  • rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
• Drug: pioglitazone hydrochloride
  • rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice
• Drug: Rosiglitazone
  • rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • dapagliflozin 2.5mg + Glimepiride
• Experimental: 2
  • dapagliflozin 5mg + Glimepiride
• Experimental: 3
  • dapagliflozin 10mg + Glimepiride
• Placebo Comparator: 4
  • Placebo + Glimepiride

Primary Measures

• To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycaemic control in subjects with type 2 diabetes, as determined by the change in A1C levels from baseline to Week 24
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.
  • Time Frame: 24 weeks
    Safety Issue?: Yes
• To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose level as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.
  • Time Frame: 24 weeks
    Safety Issue?: No
• To show that dapagliflozin plus glimepiride results in a larger proportion of subjects achieving a therapeutic glycaemic response, defined as A1C < 7% after 24 weeks of treatment, compared to placebo plus glimepiride.
  • Time Frame: 24 weeks
    Safety Issue?: No

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

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 Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Krzysztof Strojek, Prof. Dr. Principal Investigator Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland  

Overall Contact: AstraZeneca Clinical Study Information +1-800-236-9933 information.center@astrazeneca.com

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00680745

Study ID Number: D1690C00005

ClinicalTrials.gov Identifier: NCT00680745

Health Authority: Czech Republic: State Institute for Drug Control