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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:
ClinicalTrials.gov Identifier:
NCT00933972
First Posted: July 8, 2009
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Blood glucose; meal tolerance test [ Time Frame: Days 1-3 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00933972     History of Changes
Other Study ID Numbers: BP22321
2008-008128-34
First Submitted: July 6, 2009
First Posted: July 8, 2009
Last Update Posted: November 2, 2016
Last Verified: November 2016

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