A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus - Full Text View

Purpose

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	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:

MedlinePlus related topics: Diabetes Type 2

U.S. FDA Resources

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 (Adult, Senior)
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

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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, 1233

Sofia, Bulgaria, 1303

Sofia, Bulgaria, 1431

Sofia, Bulgaria, 1606
Croatia

Zagreb, Croatia, 10000
Guatemala

Guatemala City, Guatemala, 01015
Hungary

Budapest, Hungary, 1083

Budapest, Hungary, 1088

Gyor, Hungary, 9024

Kecskemet, Hungary, 6000
Mexico

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
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


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 1, 2016
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 September 26, 2016