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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00368368
First received: August 22, 2006
Last updated: April 7, 2014
Last verified: April 2014

August 22, 2006
April 7, 2014
January 2006
August 2007   (final data collection date for primary outcome measure)
Vital signs, adverse events, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Safety: Vital signs, adverse events, laboratory tests. PK: Plasma and urine GK Activator (2) AUC 0-inf. PD: AUC 0-6 glucose.
Complete list of historical versions of study NCT00368368 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
PK: AUC, Tmax, Cmax, T1/2, CL/F, CLR for GK Activator (2) and metabolite. PD: glucose Cmax & Cmin, and percentage decrease in glucose from baseline.
Not Provided
Not Provided
 
A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: GK Activator (2)
100mg po
  • Experimental: 1
    Intervention: Drug: GK Activator (2)
  • Experimental: 2
    Intervention: Drug: GK Activator (2)
  • Experimental: 3
    Intervention: Drug: GK Activator (2)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for >=1 week prior to dosing with GK Activator (2);
  • normal renal function, or moderate or severe impairment.

Exclusion Criteria:

  • type 1 diabetes;
  • treatment with insulin or PPAR gamma agonist within 6 months of screening.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Slovakia
 
NCT00368368
NP19470
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP