A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800176
First received: December 1, 2008
Last updated: July 7, 2014
Last verified: July 2014

December 1, 2008
July 7, 2014
January 2009
April 2010   (final data collection date for primary outcome measure)
Absolute change in HbA1c [ Time Frame: From baseline to end of treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00800176 on ClinicalTrials.gov Archive Site
  • Absolute change in parameters of glycemic control [ Time Frame: From baseline to end of treatment period ] [ Designated as safety issue: No ]
  • Absolute change in body weight, waist-to-hip ratio, waist circumference [ Time Frame: From baseline to end of treatment period ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
A Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled 12-week Study to Investigate Glycemic Parameters of Efficacy, Safety/ Tolerability and Pharmacokinetics of Five Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus

This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 do ses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throug hout the study.The anticipated time on study treatment is <=3 months

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: RO4998452
    2.5mg po daily for 12 weeks
  • Drug: RO4998452
    5mg po daily for 12 weeks
  • Drug: RO4998452
    10mg po daily for 12 weeks
  • Drug: RO4998452
    20mg po daily for 12 weeks
  • Drug: RO4998452
    40mg po daily for 12 weeks
  • Drug: Placebo
    po daily for 12 weeks
  • Experimental: 1
    Intervention: Drug: RO4998452
  • Experimental: 2
    Intervention: Drug: RO4998452
  • Experimental: 3
    Intervention: Drug: RO4998452
  • Experimental: 4
    Intervention: Drug: RO4998452
  • Experimental: 5
    Intervention: Drug: RO4998452
  • Placebo Comparator: 6
    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
405
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes, diagnosed for >=3 months;
  • either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
  • currently or within 6 months prior to screening treated with any PPARgamma agonist;
  • uncontrolled hypertension;
  • significant pre-diagnosed diabetic complications requiring treatment.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Canada,   Germany,   Hong Kong,   Japan,   Latvia,   Mexico,   Romania,   Russian Federation,   Spain
 
NCT00800176
BC21587, 2008-001249-24
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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