A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.

Roche

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: RO4998452; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00682097

2007-007120-18

BP21549

Details and patient eligibility

About

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-65 years of age;
• type 2 diabetes;
• either treated by diet and exercise alone or with metformin.

Exclusion criteria

• type 1 diabetes mellitus;
• uncontrolled hypertension;
• clinically severe diabetic complications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 7 patient groups

1

Experimental group

Treatment:

Drug: RO4998452

Drug: placebo

2

Experimental group

Treatment:

Drug: RO4998452

Drug: placebo

3

Experimental group

Treatment:

Drug: RO4998452

Drug: placebo

4

Experimental group

Treatment:

Drug: RO4998452

Drug: placebo

5

Experimental group

Treatment:

Drug: RO4998452

Drug: placebo

6

Experimental group

Treatment:

Drug: RO4998452

Drug: placebo

7

Experimental group

Treatment:

Drug: RO4998452

Drug: placebo