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A Study to Evaluate the Long-Term Safety and Tolerability 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:
NCT00316758
First received: April 20, 2006
Last updated: November 3, 2014
Last verified: November 2014

April 20, 2006
November 3, 2014
February 2006
October 2007   (final data collection date for primary outcome measure)
AEs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events; laboratory tests; physical examination.
Complete list of historical versions of study NCT00316758 on ClinicalTrials.gov Archive Site
Mean change from original baseline in HbA1c, FPG, lipid profile. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Mean change from baseline in HbA1c and FPG; categorical assessment of HbA1c response rate; mean change from baseline in lipid profile.
Not Provided
Not Provided
 
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249

This study will evaluate the long-term safety and tolerability of GK Activator ( 2) at doses ranging from 25mg - 100mg po bid, administered alone or in combinati on with metformin, in patients with type 2 diabetes. Eligible patients will be t hose who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regim en (mono or combination therapy) as they received in the initial study. The anti cipated time on study treatment is 3-12 months, and the target sample size is 10 0-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: GK Activator (2)
    Escalating doses bid
  • Drug: Metformin
    As prescribed, in patients who were in study BM18249
Experimental: 1
Interventions:
  • Drug: GK Activator (2)
  • 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
259
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 2 diabetic patients who have completed studies BM18248 or BM18249;
  • patients considered by the investigator to be suitable for long term treatment with GK Activator (2).

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Bulgaria,   Canada,   Croatia,   Germany,   Guatemala,   Hungary,   Mexico,   Poland
 
NCT00316758
NC19794
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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