A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.

Phase 2

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: RO4876904; Drug: Placebo

• Registration Number: NCT00502710
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Disposition First Submitted: 2016-07-28
• Status Verified: 2016-08
• Disposition First Submitted QC: 2016-08-03
• Last Update Submitted: 2016-08-03
• Disposition First Posted: 2016-08-05
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

Inclusion Criteria

• adult patients, 18-75 years of age;
• type 2 diabetes diagnosed >= 1 month before screening;
• drug-naive, or pretreated with maximum tolerated dose (MTD) of metformin;
• BMI 25-45kg/m2.

Exclusion Criteria

• type 1 diabetes;
• any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RO4876904 2	RO4876904	Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
RO4876904 3	RO4876904	Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
Placebo	Placebo	Placebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
RO4876904 4	RO4876904	Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.
RO4876904 1	RO4876904	Escalating doses, at a starting dose of 12.5mg po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Primary Outcome Measures

Name	Time	Method
Absolute change in hemoglobin A1c (HbA1c)	Week 12

Secondary Outcome Measures

Name	Time	Method
Absolute change in fasting plasma glucose (FPG), HbA1c response rate, absolute/relative change in insulin sensitivity, beta cell function, lipid profile.	Week 12
Adverse events (AEs), vital signs, laboratory parameters.	Throughout study