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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:
ClinicalTrials.gov Identifier:
NCT00316758
First Posted: April 21, 2006
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
April 20, 2006
April 21, 2006
November 2, 2016
February 2006
October 2007   (Final data collection date for primary outcome measure)
AEs, laboratory parameters, ECG. [ Time Frame: Throughout study ]
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 ]
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 combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Bulgaria,   Canada,   Croatia,   Germany,   Guatemala,   Hungary,   Mexico,   Poland,   United States
United Kingdom
 
NCT00316758
NC19794
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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