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: September 22, 2014
Last verified: September 2014

August 22, 2006
September 22, 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 pharmacokineti cs/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and wi ll evaluate the effect of renal function on the safety of the drug. Patients wil l be assigned to treatment groups according to their renal function (normal, mod erate renal impairment, or severe renal impairment). After a 1 week washout peri od 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 t he 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
September 2014

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