A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: RO4998452; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00800176

BC21587

2008-001249-24

Details and patient eligibility

About

This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is <=3 months

Enrollment: 394 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 for >=3 months;
• either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion criteria

• type 1 diabetes mellitus;
• currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
• currently or within 6 months prior to screening treated with any PPARgamma agonist;
• uncontrolled hypertension;
• significant pre-diagnosed diabetic complications requiring treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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394 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.

Treatment:

Drug: Placebo

RO4998452 10mg

Experimental group

Description:

During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.

Treatment:

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

RO4998452 2.5mg

Experimental group

Description:

During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.

Treatment:

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

RO4998452 20mg

Experimental group

Description:

During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.

Treatment:

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

RO4998452 40mg

Experimental group

Description:

During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.

Treatment:

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

RO4998452 5mg

Experimental group

Description:

During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.

Treatment:

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452

Drug: RO4998452