Trial Information

Summary: A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

Status: Completed

Protocol Number: BM18106

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of the DPP-IV inhibitor on HbA1c and safety in patients with type 2 diabetes treated with a stable dose of metformin

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. Target sample size is 200.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Diabetes Mellitus, Type 2

Intervention Type: Drug

Intervention Name: DPP-IV Inhibitor

Primary Outcome: 1. Absolute change from baseline in HbAlc Time frame: Week 16

Key Secondary Outcomes: 1. Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate Time frame: Week 16 2. AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 07/26/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:31:22 PM