Trial Information

Summary: A Study of DPP-IV (3) in Patients With Type 2 Diabetes.

Status: Completed

Protocol Number: BC20779

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind dose-ranging study of the effect of DPP-IV (3) on HbA1c, other efficacy parameters, pharmacokinetics and safety in patients with type 2 diabetes (BC20779)

Brief Summary: This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. Patients receiving metformin before the study will continue on the same 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 250.

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 (3)

Primary Outcome: 1. Absolute change in HbAlc Time frame: Week 12

Key Secondary Outcomes: 1. Absolute change in FPG, HbAlc response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile. Time frame: Week 12 2. AEs, vital signs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2007

Trial Registration Date: 07/19/2007

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:33:21 PM