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

Study Description

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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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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 ]

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00266240 History of Changes
Other Study ID Numbers:	BM18248
First Posted:	December 16, 2005
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