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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00823680

Run by

Hoffmann-La Roche

People needed

110

Starts

2009-04-01

Expected to finish

2009-08-01

Last updated by the study team

2016-07-28

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Chula Vista, California, United States
• Study site — Miami, Florida, United States
• Study site — Graz, Austria
• Study site — München, Germany
• Study site — Neuss, Germany

Full record on ClinicalTrials.gov

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