Trial Information

Summary: A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.

Status: Completed

Protocol Number: NP19470

Sponsor: Hoffman-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study to investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics and safety of GK Activator (2) following a single oral dose administration in patients with type 2 diabetes.

Brief Summary: This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 20.

Study Phase: I

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Parallel
• Endpoints: Pharmacokinetics/dynamics

Study Type:

Condition: Diabetes Mellitus, Type 2

Intervention Type: Drug

Intervention Name: GK Activator (2)

Primary Outcome: 1. Vital signs, adverse events, laboratory parameters. Time frame: Throughout study

Key Secondary Outcomes: 1. AUC, Tmax, Cmax, T1/2, CL/F, CLR for GK Activator (2) and metabolite. Glucose Cmax and Cmin, and percentage decrease in glucose from baseline. Time frame: Throughout study.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/16/2006

Date Last Updated: 10/16/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:36:24 PM