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

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Placebo; Drug: RO4876904

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502710

BC20779

Details and patient eligibility

About

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.

Enrollment: 289 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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289 participants in 5 patient groups, including a placebo group

RO4876904 1

Experimental group

Description:

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.

Treatment:

Drug: RO4876904

RO4876904 2

Experimental group

Description:

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.

Treatment:

Drug: RO4876904

RO4876904 3

Experimental group

Description:

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.

Treatment:

Drug: RO4876904

RO4876904 4

Experimental group

Description:

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.

Treatment:

Drug: RO4876904

Placebo

Placebo Comparator group

Description:

Placebo po daily. Patients receiving metformin before the study will continue on the same dose of metformin.

Treatment:

Drug: Placebo