A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00266240 |
Recruitment Status
:
Completed
First Posted
: December 16, 2005
Last Update Posted
: November 2, 2016
|
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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 |

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
|
- HbA1c mean change from baseline, compared to placebo. [ Time Frame: Week 12 ]
- Additional parameters of glycemic and lipid control. [ Time Frame: Week 12 ]
- AEs, laboratory parameters. [ Time Frame: Throughout study ]
- Pharmacokinetic and exposure-response relationship [ Time Frame: Throughout study ]

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Ages Eligible for Study: | 30 Years to 75 Years (Adult, Senior) |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00266240

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 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov 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 |