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

Phase 1CompletedNCT00682097

Hoffmann-La Roche55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus Type 2

Interventions

RO4998452DRUG

Escalating oral doses

placeboDRUG

Oral doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (3)

Unnamed facility

Chula Vista, California, United States

Unnamed facility

San Antonio, Texas, United States

Unnamed facility

Neuss, Germany

Outcomes

Primary Outcomes

AEs, laboratory parameters, vital signs.

Time frame: Throughout study

AUC0-24h, Cmax

Time frame: Days 1 and 14

Secondary Outcomes

Parameters of glucose metabolism

Time frame: Throughout study

Data from ClinicalTrials.gov

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