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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:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00316758
First received: April 20, 2006
Last updated: May 13, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: GK Activator (2)
Drug: Metformin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from original baseline in HbA1c, FPG, lipid profile. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 259
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: 1 Drug: GK Activator (2)
Escalating doses bid
Drug: Metformin
As prescribed, in patients who were in study BM18249

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316758

  Hide Study Locations
Locations
United States, California
Chula Vista, California, United States, 91911
Chula Vista, California, United States, 91910
Los Angeles, California, United States, 90057
Spring Valley, California, United States, 91978
West Hills, California, United States, 91307
United States, Florida
Hollywood, Florida, United States, 33021
Kissimmee, Florida, United States, 34741
United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Kansas
Arkansas City, Kansas, United States, 67005
United States, Montana
Butte, Montana, United States, 59701
United States, New York
Binghamton, New York, United States, 13901
United States, North Carolina
Fayetteville, North Carolina, United States, 28304
Statesville, North Carolina, United States, 28625
Winston-salem, North Carolina, United States, 27103
United States, Ohio
Springdale, Ohio, United States, 45246
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Medford, Oregon, United States, 97504
United States, Pennsylvania
Beaver, Pennsylvania, United States, 15009
United States, South Carolina
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Washington
Federal Way, Washington, United States, 98003
Renton, Washington, United States, 98055
Australia
Heidelberg, Australia, 3081
Sydney, Australia, 2050
Bulgaria
Dimitrovgrad, Bulgaria, 6400
Pleven, Bulgaria, 5800
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1233
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
London, Ontario, Canada, N6A 4V2
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Croatia
Zagreb, Croatia, 10000
Germany
Bammental, Germany, 69245
Berlin, Germany, 10115
Essen, Germany, 45355
Giessen, Germany, 35385
Görlitz, Germany, 02826
Hamburg, Germany, 20249
Kuenzing, Germany, 94550
Nürnberg, Germany, 90402
Tann, Germany, 36142
Guatemala
Guatemala City, Guatemala, 01015
Hungary
Budapest, Hungary, 1083
Gyor, Hungary, 9024
Kecskemet, Hungary, 6000
Mexico
Chihuahua, Mexico, 31238
Cuernavaca, Mexico, 62270
Durango, Mexico, 34070
Mexico City, Mexico, 11650
Mexico City, Mexico, 06700
Mexico City, Mexico, 14610
Mexico City, Mexico, 14050
Poland
Bialystok, Poland, 15-276
Gdansk, Poland, 80-757
Gorzow, Poland, 66-400
Krakow, Poland, 31-121
Wroclaw, Poland, 50-088
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00316758     History of Changes
Other Study ID Numbers: NC19794
Study First Received: April 20, 2006
Last Updated: May 13, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013