Efficacy and Safety of Dapagliflozin in Combination with Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients
Study identifier:D1690C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Type 2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
dapagliflozin, Glimepiride, metformin hydrochloride, pioglitazone hydrochloride, Rosiglitazone
Sex
All
Actual Enrollment
597
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Apr 2008
Primary Completion Date: 01 Nov 2009
Study Completion Date: 01 May 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Krzysztof Strojek
Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland
