A Dose-Titration Study 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:
NCT00366379
First received: August 16, 2006
Last updated: August 4, 2014
Last verified: August 2014

August 16, 2006
August 4, 2014
July 2006
June 2007   (final data collection date for primary outcome measure)
Percentage of patients at each dose who achieve FPG <100mg/dL. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Percentage of patients at each dose who achieve FPG <100mg/dL.
Complete list of historical versions of study NCT00366379 on ClinicalTrials.gov Archive Site
  • Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile. [ Time Frame: At intervals throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile. Safety: AEs, laboratory tests.
Not Provided
Not Provided
 
A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.
An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.

This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not be en optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive G K Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bi d to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is <3 months, and t he target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: GK Activator (2)
25-200mg po bid for 20 weeks
  • Experimental: 1
    Intervention: Drug: GK Activator (2)
  • Experimental: 2
    Intervention: Drug: GK Activator (2)
  • Experimental: 3
    Intervention: Drug: GK Activator (2)
  • Experimental: 4
    Intervention: Drug: GK Activator (2)
  • Experimental: 5
    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
127
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months prior to screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
  • women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Estonia,   Latvia,   Mexico
 
NCT00366379
BC19800
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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