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

NCT ID: NCT00682097

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

Escalating oral doses

placebo

Intervention Type DRUG

Oral doses

2

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

Escalating oral doses

placebo

Intervention Type DRUG

Oral doses

3

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

Escalating oral doses

placebo

Intervention Type DRUG

Oral doses

4

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

Escalating oral doses

placebo

Intervention Type DRUG

Oral doses

5

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

Escalating oral doses

placebo

Intervention Type DRUG

Oral doses

6

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

Escalating oral doses

placebo

Intervention Type DRUG

Oral doses

7

Group Type EXPERIMENTAL

RO4998452

Intervention Type DRUG

Escalating oral doses

placebo

Intervention Type DRUG

Oral doses

Interventions

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RO4998452

Escalating oral doses

Intervention Type DRUG

placebo

Oral doses

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Chula Vista, California, United States

Site Status

San Antonio, Texas, United States

Site Status

Neuss, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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2007-007120-18

Identifier Type: -

Identifier Source: secondary_id

BP21549

Identifier Type: -

Identifier Source: org_study_id