We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00368368
First Posted: August 24, 2006
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
August 22, 2006
August 24, 2006
November 2, 2016
January 2006
August 2007   (Final data collection date for primary outcome measure)
Vital signs, adverse events, laboratory parameters. [ Time Frame: Throughout study ]
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. ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Slovakia,   United States
 
 
NCT00368368
NP19470
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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