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

Roche

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Placebo; Drug: RO5093151; Drug: RO5027838

Study type: Interventional

Funder types: Industry

Identifiers

NCT00823680

BP21850

2008-001122-13

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

110 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

RO5027838 200mg

Experimental group

Treatment:

Drug: RO5027838

Drug: RO5027838

RO5027838 50mg

Experimental group

Treatment:

Drug: RO5027838

Drug: RO5027838

RO5093151 10mg

Experimental group

Treatment:

Drug: RO5093151

Drug: RO5093151

RO5093151 400mg

Experimental group

Treatment:

Drug: RO5093151

Drug: RO5093151