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

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: NCT00266240
Recruitment Status : Completed
First Posted : December 16, 2005
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 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) Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. HbA1c mean change from baseline, compared to placebo. [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Additional parameters of glycemic and lipid control. [ Time Frame: Week 12 ]
  2. AEs, laboratory parameters. [ Time Frame: Throughout study ]
  3. Pharmacokinetic and exposure-response relationship [ 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:

  • 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.

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): NCT00266240

  Hide Study 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
Dimitrovgrad, Bulgaria, 6400
Pleven, Bulgaria, 5800
Ruse, Bulgaria, 7002
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1303
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1606
Zagreb, Croatia, 10000
Guatemala City, Guatemala, 01015
Budapest, Hungary, 1083
Budapest, Hungary, 1088
Gyor, Hungary, 9024
Kecskemet, Hungary, 6000
Chihuahua, Mexico, 31238
Cuernavaca, Mexico, 62250
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: NCT00266240     History of Changes
Other Study ID Numbers: BM18248
First Posted: December 16, 2005    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