Study identifier:H8O-MC-GWCH (DURATION - 4)
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Safety and Efficacy of Exenatide Once Weekly Injection versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients with Type 2 Diabetes
Type 2 Diabetes Mellitus
Phase 3
No
exenatide once weekly, metformin, sitagliptin, pioglitazone
All
820
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Eli Lilly and Company
This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.
Location
Location
Sevilla, Spain
Location
Alicante, Spain
Location
Madrid, Spain
Location
Barcelona, Spain
Location
Swansea, United Kingdom
Location
Guildford, United Kingdom
Location
Hull, United Kingdom
Location
Sheffield, United Kingdom
Arms | Assigned Interventions |
---|---|
Experimental: Exenatide Once Weekly | Drug: exenatide once weekly subcutaneous injection, 2mg, once weekly plus placebo oral once daily |
Active Comparator: Metformin | Drug: metformin oral, 1000-2500mg, daily plus placebo once weekly subcutaneous injection |
Active Comparator: Sitagliptin | Drug: sitagliptin oral, 100 mg, daily plus placebo once weekly subcutaneous injection |
Active Comparator: Pioglitazone | Drug: pioglitazone oral, 30-45mg, daily plus placebo once weekly subcutaneous injection |
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