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A Dose-Titration Study 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.
ClinicalTrials.gov Identifier: NCT00366379
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.
Study Start Date : July 2006
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: GK Activator (2)
25-200mg po bid for 20 weeks
Experimental: 2 Drug: GK Activator (2)
25-200mg po bid for 20 weeks
Experimental: 3 Drug: GK Activator (2)
25-200mg po bid for 20 weeks
Experimental: 4 Drug: GK Activator (2)
25-200mg po bid for 20 weeks
Experimental: 5 Drug: GK Activator (2)
25-200mg po bid for 20 weeks

Primary Outcome Measures :
  1. Percentage of patients at each dose who achieve FPG <100mg/dL. [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile. [ Time Frame: At intervals throughout study ]
  2. AEs, laboratory parameters. [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months prior to screening.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
  • 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 ClinicalTrials.gov identifier (NCT number): NCT00366379

United States, Arizona
Chandler, Arizona, United States, 85225
United States, Florida
Oviedo, Florida, United States, 32765
United States, Idaho
Nampa, Idaho, United States, 83687
United States, Indiana
Evansville, Indiana, United States, 47714
United States, Montana
Butte, Montana, United States, 59701
United States, Ohio
Canton, Ohio, United States, 44718
United States, Oregon
Portland, Oregon, United States, 97239
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, Texas
Midland, Texas, United States, 79707
United States, Virginia
Richmond, Virginia, United States, 23249
Tallinn, Estonia, 10138
Tartu, Estonia, 50406
Tartu, Estonia, 50708
Tartu, Estonia, 51014
Jelgava, Latvia, 3001
Riga, Latvia, 1002
Riga, Latvia, 1038
Chihuahua, Mexico, 31238
Guadalajara, Mexico, 44340
Guadalajara, Mexico, 44650
Pachuca, Mexico, 42086
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00366379     History of Changes
Other Study ID Numbers: BC19800
First Posted: August 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