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


Tracking Information

Start Date  ICMJEJune 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: July 7, 2009)		Creatinine clearance; Pk parameters; adverse events [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00933972 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 7, 2009)		Blood glucose; meal tolerance test [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of RO4998452 in Type 2 Diabetes Patients With Varying Degrees of Renal Impairment
Official Title  ICMJEEffect 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.
Brief Summary

This 4 arm study will investigate the pharmacodynamics and pharmacokinetics of RO4998452 in type 2 diabetes patients with varying degrees of renal impairment. Eligible patients will be divided into 4 groups, with normal renal function, or mild, moderate or severe renal impairment. All patients will receive a single oral 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.

Detailed Description 
Study PhasePhase I
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study
Condition  ICMJEDiabetes Mellitus, Type 2
Intervention  ICMJEDrug: RO4998452
20mg po single dose
Study Arms / Comparison Groups
  • 1 (normal): Experimental
    Intervention: Drug: RO4998452
  • 2 (mild): Experimental
    Intervention: Drug: RO4998452
  • 3 (moderate): Experimental
    Intervention: Drug: RO4998452
  • 4 (severe): Experimental
    Intervention: Drug: RO4998452

Recruitment Information

Estimated Enrollment  ICMJE32
Estimated Completion DateDecember 2009
Primary Completion Date 
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages40 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: BP22321888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEUnited States,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00933972
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEBP22321, 2008-008128-34
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche