A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00266240
First received: December 15, 2005
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetic s of oral GK Activator (2), compared to placebo, in patients with type 2 diabete s mellitus. The anticipated time on study treatment is less than 3 months, and t he target sample size is 100-500 individuals.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • HbA1c mean change from baseline, compared to placebo. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional parameters of glycemic and lipid control. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Pharmacokinetic and exposure-response relationship [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: November 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: GK Activator (2)
Escalating doses po bid
Experimental: 2 Drug: GK Activator (2)
Escalating doses po bid
Experimental: 3 Drug: GK Activator (2)
Escalating doses po bid
Experimental: 4 Drug: GK Activator (2)
Escalating doses po bid
Placebo Comparator: 5 Drug: Placebo
po bid

  Eligibility

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

Inclusion Criteria:

  • adult patients 30-75 years of age;
  • type 2 diabetes mellitus for >3 months before screening;
  • treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • 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: NCT00266240

  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States, 85723
United States, Arkansas
Pine Bluff, Arkansas, United States, 71603
United States, California
Chula Vista, California, United States, 91911
Spring Valley, California, United States, 91978
West Hills, California, United States, 91307
United States, Florida
Hollywood, Florida, United States, 33021
United States, Georgia
Atlanta, Georgia, United States, 30308
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
Tipton, Pennsylvania, United States, 16684
United States, South Carolina
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Plano, Texas, United States, 75093
United States, Washington
Renton, Washington, United States, 98055
Bulgaria
Dimitrovgrad, Bulgaria, 6400
Pleven, Bulgaria, 5800
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1303
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1233
Croatia
Zagreb, Croatia, 10000
Guatemala
Guatemala City, Guatemala, 01015
Hungary
Budapest, Hungary, 1088
Budapest, Hungary, 1083
Gyor, Hungary, 9024
Kecskemet, Hungary, 6000
Mexico
Chihuahua, Mexico, 31238
Cuernavaca, Mexico, 62250
Durango, Mexico, 34070
Mexico City, Mexico, 11650
Mexico City, Mexico, 14610
Mexico City, Mexico, 14050
Mexico-city, Mexico, 06700
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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00266240     History of Changes
Other Study ID Numbers: BM18248
Study First Received: December 15, 2005
Last Updated: September 22, 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

ClinicalTrials.gov processed this record on October 01, 2014