A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Registration Number
- EUCTR2010-023759-27-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
Patient is =18 and =79 years of age with T2DM.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Patient has a history of type 1 diabetes mellitus or history of ketoacidosis.
2. Patient has been treated with any antihyperglycemic agent therapies other than metformin monotherapy within the prior 12 weeks of Visit 1/Screening Visit.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: After 26 weeks, in patients with T2DM with inadequate glycemic control on metformin monotherapy: To assess the effect of a sitagliptin-based treatment paradigm compared with a liraglutide-based treatment paradigm on A1C. ;Secondary Objective: After 26 weeks, to assess the effect of a sitagliptin-based treatment paradigm compared with a liraglutide-based treatment paradigm: 1). fasting plasma glucose (FPG). 2). The proportion of patient at the glycemic goals of A1C <7.0% and <6.5%. ;Primary end point(s): A1C change form baseline at Week 26
- Secondary Outcome Measures
Name Time Method