A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00266253
First received: December 15, 2005
Last updated: July 7, 2014
Last verified: July 2014

December 15, 2005
July 7, 2014
November 2005
March 2007   (final data collection date for primary outcome measure)
HbA1c mean change from baseline compared with placebo. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00266253 on ClinicalTrials.gov 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 Treated With a Stable Dose of Metformin
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 Treated With a Stable Dose of Metformin.

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetic s of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients wi ll continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is l ess than 3 months, and the target sample size is 100-500 individuals.

Not Provided
Interventional
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 or qd for 12 weeks.
  • Drug: Metformin
    As prescribed, for 12 weeks
  • Experimental: 1
    Interventions:
    • Drug: GK Activator (2)
    • Drug: Metformin
  • Experimental: 2
    Interventions:
    • Drug: GK Activator (2)
    • Drug: Metformin
  • Experimental: 3
    Interventions:
    • Drug: GK Activator (2)
    • Drug: Metformin
  • Experimental: 4
    Interventions:
    • Drug: GK Activator (2)
    • Drug: Metformin
  • Experimental: 5
    Interventions:
    • Drug: GK Activator (2)
    • Drug: Metformin
  • Active Comparator: 6
    Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients 30-75 years of age;
  • type 2 diabetes mellitus;
  • individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Germany,   Spain,   United Kingdom
 
NCT00266253
BM18249
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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