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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00823680
First received: January 15, 2009
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: RO5093151
Drug: RO5027838
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change in mean daily plasma glucose [ Time Frame: From baseline to day 27 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose [ Time Frame: Baseline, and weeks 1, 2, 3 and 4 ] [ Designated as safety issue: No ]
  • Post-prandial glucose and insulin [ Time Frame: Baseline, weeks 2 and 4 ] [ Designated as safety issue: No ]
  • Insulin sensitivity, beta cell function, lipid profile, HbA1C [ Time Frame: At baseline, and at planned visits up to week 4 ] [ Designated as safety issue: No ]
  • Adverse events, lab parameters, vital signs, body weight [ Time Frame: At baseline, and at planned visits up to week 4 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO5093151
400mg po bid for 4 weeks
Experimental: 2 Drug: RO5093151
10mg po bid for 4 weeks
Experimental: 3 Drug: RO5027838
200mg po qd for 4 weeks
Experimental: 4 Drug: RO5027838
50mg po bid for 4 weeks
Placebo Comparator: 5 Drug: Placebo
po bid for 4 weeks

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 PPAR agonist;
  • treated with lipoprotein-modifying therapy within a month before screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823680

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00823680     History of Changes
Other Study ID Numbers: BP21850, 2008-001122-13
Study First Received: January 15, 2009
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013