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

Phase 2

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: RO5027838; Drug: Placebo; Drug: RO5093151

• Registration Number: NCT00823680
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-16
• Study Start: 2009-04
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2016-07
• Disposition First Submitted: 2016-07-26
• Disposition First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Disposition First Posted: 2016-07-28
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RO5027838 200mg	RO5027838	-
RO5027838 50mg	RO5027838	-
Placebo	Placebo	-
RO5093151 400mg	RO5093151	-
RO5093151 10mg	RO5093151	-

Primary Outcome Measures

Name	Time	Method
Absolute change in mean daily plasma glucose	From baseline to day 27

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose	Baseline, and weeks 1, 2, 3 and 4
Post-prandial glucose and insulin	Baseline, weeks 2 and 4
Insulin sensitivity, beta cell function, lipid profile, HbA1C	At baseline, and at planned visits up to week 4
Adverse events, lab parameters, vital signs, body weight	At baseline, and at planned visits up to week 4