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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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00933972
First received: July 6, 2009
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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.


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:


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 Start Date: June 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: November 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014