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

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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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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