A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

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. Identifier: NCT00316758
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: GK Activator (2) Drug: Metformin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: GK Activator (2)
Escalating doses bid

Drug: Metformin
As prescribed, in patients who were in study BM18249

Primary Outcome Measures :
  1. AEs, laboratory parameters, ECG. [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Mean change from original baseline in HbA1c, FPG, lipid profile. [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316758

  Hide Study Locations
United States, California
Chula Vista, California, United States, 91910
Chula Vista, California, United States, 91911
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
Camperdown, Australia, 2050
Heidelberg, Australia, 3081
Dimitrovgrad, Bulgaria, 6400
Pleven, Bulgaria, 5800
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1606
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
London, Ontario, Canada, NGA 4V2
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Zagreb, Croatia, 10000
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 City, Guatemala, 01015
Budapest, Hungary, 1083
Gyor, Hungary, 9024
Kecskemet, Hungary, 6000
Chihuahua, Mexico, 31238
Cuernavaca, Mexico, 62270
Durango, Mexico, 34070
Mexico City, Mexico, 11650
Mexico City, Mexico, 14050
Mexico City, Mexico, 14610
Mexico-city, Mexico, 06700
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
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00316758     History of Changes
Other Study ID Numbers: NC19794
First Posted: April 21, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases