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

Study Overview
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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.

Official Title
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Multi-center, Randomized, Double-blind, 5-arm Parallel Group, Placebo Controlled 4 Week Study to Investigate the Safety, Tolerability and Efficacy of Two Doses Each (Near to Maximum Tolerated Dose and Lower Dose) of RO5093151 Administered Twice Daily (BID Regimen) and RO5027838 Administered Once da

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Placebo
* Drug: RO5027838
* Drug: RO5027838
* Drug: RO5093151
* Drug: RO5093151


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* po bid for 4 weeks<br>|
| Experimental: RO5027838 200mg<br> | Drug: RO5027838<br>* 200mg po qd for 4 weeks<br>|
| Experimental: RO5027838 50mg<br> | Drug: RO5027838<br>* 50mg po bid for 4 weeks<br>|
| Experimental: RO5093151 10mg<br> | Drug: RO5093151<br>* 10mg po bid for 4 weeks<br>|
| Experimental: RO5093151 400mg<br> | Drug: RO5093151<br>* 400mg po bid for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in mean daily plasma glucose |  | From baseline to day 27 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |