A Study of RO4998452 in Type 2 Diabetes Patients With Varying Degrees of Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00933972
First received: July 6, 2009
Last updated: July 7, 2014
Last verified: July 2014

July 6, 2009
July 7, 2014
June 2009
September 2010   (final data collection date for primary outcome measure)
Creatinine clearance; Pk parameters; adverse events [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00933972 on ClinicalTrials.gov Archive Site
Blood glucose; meal tolerance test [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of RO4998452 in Type 2 Diabetes Patients With Varying Degrees of Renal Impairment
Effect of Renal Impairment on Pharmacodynamics and Pharmacokinetics of RO4998452: A Multiple-center, Open-label, Parallel Group Study Following Single Oral Dosing of RO4998452 to Type 2 Diabetes Patients With Varying Degrees of Renal Impairment.

This 4 arm study will investigate the pharmacodynamics and pharmacokinetics of R O4998452 in type 2 diabetes patients with varying degrees of renal impairment. E ligible patients will be divided into 4 groups, with normal renal function, or m ild, moderate or severe renal impairment. All patients will receive a single ora l dose of RO4998452 in the fasted state.The anticipated time on study treatment is <3 months (single dose study)and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: RO4998452
20mg po single dose
  • Experimental: 1 (normal)
    Intervention: Drug: RO4998452
  • Experimental: 2 (mild)
    Intervention: Drug: RO4998452
  • Experimental: 3 (moderate)
    Intervention: Drug: RO4998452
  • Experimental: 4 (severe)
    Intervention: Drug: RO4998452
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 40-80 years of age;
  • type 2 diabetes;
  • normal renal function, or impaired but stable renal function;
  • stable with regard to medication or treatment regimen taken for renal impairment or diabetes.

Exclusion Criteria:

  • patients with a renal transplant;
  • end-stage renal disease, requiring dialysis;
  • nephrotic syndrome, or a history of nephrectomy;
  • type 1 diabetes mellitus.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation
 
NCT00933972
BP22321, 2008-008128-34
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