Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: December 15, 2005
Last updated: March 2, 2015
Last verified: March 2015

December 15, 2005
March 2, 2015
November 2005
May 2007   (final data collection date for primary outcome measure)
HbA1c mean change from baseline, compared to placebo. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00266240 on Archive Site
  • Additional parameters of glycemic and lipid control. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Pharmacokinetic and exposure-response relationship [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus
A Randomized, Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.

Not Provided
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: GK Activator (2)
    Escalating doses po bid
  • Drug: Placebo
    po bid
  • 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)
  • Placebo Comparator: 5
    Intervention: Drug: Placebo
Not Provided

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

Inclusion Criteria:

  • adult patients 30-75 years of age;
  • type 2 diabetes mellitus for >3 months before screening;
  • treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • women who are pregnant, breast-feeding or not using adequate contraceptive methods.
30 Years to 75 Years
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Croatia,   Guatemala,   Hungary,   Mexico,   Poland
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2015

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