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

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: RO4998452; Drug: placebo

• Registration Number: NCT00682097
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-22
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	placebo	-
4	RO4998452	-
1	placebo	-
1	RO4998452	-
2	RO4998452	-
2	placebo	-
6	RO4998452	-
3	RO4998452	-
6	placebo	-
4	placebo	-
5	RO4998452	-
7	RO4998452	-
5	placebo	-
7	placebo	-

Primary Outcome Measures

Name	Time	Method
AUC0-24h, Cmax	Days 1 and 14
AEs, laboratory parameters, vital signs.	Throughout study

Secondary Outcome Measures

Name	Time	Method
Parameters of glucose metabolism	Throughout study