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

Diabetes Mellitus Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933972
• Other study ID #: BP22321
• Secondary ID: 2008-008128-34
• Status: Completed
• Phase: Phase 1
• First received: July 6, 2009
• Last updated: November 1, 2016
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Renal Insufficiency

Intervention

Drug:
• RO4998452
20mg po single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine clearance; Pk parameters; adverse events		Days 1-3	No
Secondary	Blood glucose; meal tolerance test		Days 1-3	No