A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

NCT ID: NCT00823680

Last Updated: 2016-07-28

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

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-08-31

Brief Summary

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This 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is \< 3 months, and the target sample size is 100-500 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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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po bid for 4 weeks

RO5027838 200mg

Group Type EXPERIMENTAL

RO5027838

Intervention Type DRUG

200mg po qd for 4 weeks

RO5027838 50mg

Group Type EXPERIMENTAL

RO5027838

Intervention Type DRUG

50mg po bid for 4 weeks

RO5093151 10mg

Group Type EXPERIMENTAL

RO5093151

Intervention Type DRUG

10mg po bid for 4 weeks

RO5093151 400mg

Group Type EXPERIMENTAL

RO5093151

Intervention Type DRUG

400mg po bid for 4 weeks

Interventions

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Placebo

po bid for 4 weeks

Intervention Type DRUG

RO5027838

200mg po qd for 4 weeks

Intervention Type DRUG

RO5027838

50mg po bid for 4 weeks

Intervention Type DRUG

RO5093151

400mg po bid for 4 weeks

Intervention Type DRUG

RO5093151

10mg po bid for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 35-65 years of age;
* type 2 diabetes for \>=3 months;
* treated for \>=3 months with stable dose of metformin \>=1.5g/day or maximum tolerated dose.

Exclusion Criteria

* history of diabetic ketoacidosis;
* currently or previously treated with insulin;
* currently or within previous 6 months treated with a thiazolidinedione or dual peroxisome proliferator activated receptor (PPAR) agonist;
* treated with lipoprotein-modifying therapy within a month before screening.
Minimum Eligible Age

35 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

Miami, Florida, United States

Site Status

Graz, , Austria

Site Status

München, , Germany

Site Status

Neuss, , Germany

Site Status

Countries

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United States Austria Germany

Other Identifiers

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2008-001122-13

Identifier Type: -

Identifier Source: secondary_id

BP21850

Identifier Type: -

Identifier Source: org_study_id

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