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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00933972
First received: July 6, 2009
Last updated: January 18, 2011
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: RO4998452
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Creatinine clearance; Pk parameters; adverse events [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood glucose; meal tolerance test [ Time Frame: Days 1-3 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 (normal) Drug: RO4998452
20mg po single dose
Experimental: 2 (mild) Drug: RO4998452
20mg po single dose
Experimental: 3 (moderate) Drug: RO4998452
20mg po single dose
Experimental: 4 (severe) Drug: RO4998452
20mg po single dose

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933972

Locations
United States, Washington
Renton, Washington, United States, 98055
Russian Federation
Moscow, Russian Federation, 115419
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00933972     History of Changes
Other Study ID Numbers: BP22321, 2008-008128-34
Study First Received: July 6, 2009
Last Updated: January 18, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013