A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
- Registration Number
- NCT00111670
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is \< 3 months and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 291
Inclusion Criteria
- adult patients 18-75 years of age;
- type 2 diabetes diagnosed >=1 month before screening;
- no previous treatment, or previous treatment with no more than 2 oral medications.
Exclusion Criteria
- type 1 diabetes;
- type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening;
- patients who are pregnant, breastfeeding or not using a reliable contraceptive method.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 DPP-IV Inhibitor - 4 DPP-IV Inhibitor - 5 Placebo - 1 DPP-IV Inhibitor - 2 DPP-IV Inhibitor -
- Primary Outcome Measures
Name Time Method Absolute change from baseline in HbAlc\n\n Week 12
- Secondary Outcome Measures
Name Time Method Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate Week 12 AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n Throughout study