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: April 7, 2014
Last verified: April 2014

January 15, 2009
April 7, 2014
April 2009
March 2010   (final data collection date for primary outcome measure)
Absolute change in mean daily plasma glucose [ Time Frame: From baseline to day 27 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00823680 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: RO5093151
    400mg po bid for 4 weeks
  • Drug: RO5093151
    10mg po bid for 4 weeks
  • Drug: RO5027838
    200mg po qd for 4 weeks
  • Drug: RO5027838
    50mg po bid for 4 weeks
  • Drug: Placebo
    po bid for 4 weeks
  • Experimental: 1
    Intervention: Drug: RO5093151
  • Experimental: 2
    Intervention: Drug: RO5093151
  • Experimental: 3
    Intervention: Drug: RO5027838
  • Experimental: 4
    Intervention: Drug: RO5027838
  • Placebo Comparator: 5
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
35 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Germany
 
NCT00823680
BP21850, 2008-001122-13
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP