A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Phase 2
Completed
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Registration Number
- NCT00111631
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 218
Inclusion Criteria
- adult patients 18-75 years of age;
- type 2 diabetes;
- stable metformin therapy for >=3 months before screening.
Exclusion Criteria
- women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
- type 1 diabetes;
- any anti-hyperglycemic medication other than metformin in the last 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Metformin - 2 DPP-IV Inhibitor - 3 DPP-IV Inhibitor - 4 Placebo - 1 DPP-IV Inhibitor - 2 Metformin - 4 Metformin - 3 Metformin -
- Primary Outcome Measures
Name Time Method Absolute change from baseline in HbAlc\n Week 16
- Secondary Outcome Measures
Name Time Method Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n Week 16 AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n Throughout study