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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823680
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: RO5027838 Drug: RO5093151 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
po bid for 4 weeks

Experimental: RO5027838 200mg Drug: RO5027838
200mg po qd for 4 weeks

Experimental: RO5027838 50mg Drug: RO5027838
50mg po bid for 4 weeks

Experimental: RO5093151 10mg Drug: RO5093151
10mg po bid for 4 weeks

Experimental: RO5093151 400mg Drug: RO5093151
400mg po bid for 4 weeks

Primary Outcome Measures :
  1. Absolute change in mean daily plasma glucose [ Time Frame: From baseline to day 27 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00823680

United States, California
Chula Vista, California, United States, 91911
United States, Florida
Miami, Florida, United States, 330014
Graz, Austria, 8036
München, Germany, 80636
Neuss, Germany, 41460
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00823680     History of Changes
Other Study ID Numbers: BP21850
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases