A Dose-Titration Study 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:
NCT00366379
First received: August 16, 2006
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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 be en optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive G K Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bi d 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 t he target sample size is 100-500 individuals.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients at each dose who achieve FPG <100mg/dL. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile. [ Time Frame: At intervals throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: July 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366379

Locations
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
Estonia
Tallinn, Estonia, 10138
Tartu, Estonia, 50708
Tartu, Estonia, 51014
Tartu, Estonia, 50406
Latvia
Jelgava, Latvia, 3001
Riga, Latvia, 1002
Riga, Latvia, 1038
Mexico
Chihuahua, Mexico, 31238
Guadalajara, Mexico, 44650
Guadalajara, Mexico, 44340
Pachuca, Mexico, 42086
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00366379     History of Changes
Other Study ID Numbers: BC19800
Study First Received: August 16, 2006
Last Updated: July 7, 2014
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014