A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - 75
Updated:8/3/2016
Start Date:February 2006
End Date:October 2007

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A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249

This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses
ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in
patients with type 2 diabetes. Eligible patients will be those who have completed study
BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they
will continue on the same treatment regimen (mono or combination therapy) as they received
in the initial study. The anticipated time on study treatment is 3-12 months, and the target
sample size is 100-500 individuals.


Inclusion Criteria:

- type 2 diabetic patients who have completed studies BM18248 or BM18249;

- patients considered by the investigator to be suitable for long term treatment with
GK Activator (2).

Exclusion Criteria:

- type 1 diabetes mellitus;

- women who are pregnant, breast-feeding or not using adequate contraceptive methods.
We found this trial at
22
sites
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Memphis, TN
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Arkansas City, KS
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Atlanta, GA
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Beaver, PA
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from
Binghamton, NY
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Butte, MT
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from
Camperdown,
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from
Chula Vista, CA
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Fayetteville, North Carolina 28304
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from
Fayetteville, NC
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from
Federal Way, WA
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from
Hollywood, FL
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from
Kissimmee, FL
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from
Los Angeles, CA
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mi
from
Medford, OR
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Mount Pleasant, South Carolina 29464
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from
Mount Pleasant, SC
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mi
from
Oklahoma City, OK
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mi
from
Renton, WA
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Spring Valley, California 91978
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from
Spring Valley, CA
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mi
from
Springdale, OH
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Statesville, North Carolina 28677
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mi
from
Statesville, NC
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from
West Hills, CA
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mi
from
Winston-Salem, NC
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