A Study of Aleglitazar in Patients With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:8/3/2016
Start Date:November 2006
End Date:March 2008

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A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.

This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of
aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of
6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active
comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po
daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on
study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Inclusion Criteria:

- adult patients, 18-75 years of age;

- type 2 diabetes, diagnosed >=1 month of screening;

- either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at
submaximal doses;

- HbA1c <=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.

Exclusion Criteria:

- type 1 diabetes;

- currently or previously treated with insulin, a thiazolidinedione, or a dual
Peroxisome Proliferator Activated Receptor (PPAR) agonist;

- clinically significant cardiovascular disease;

- Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.
We found this trial at
18
sites
2078
mi
from 91732
Chiefland, FL
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6881
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from 91732
Athens,
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2053
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from 91732
Augusta, GA
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2301
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from 91732
Baltimore, MD
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1589
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from 91732
Baton Rouge, LA
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Beverly Hills, California 90211
21
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from 91732
Beverly Hills, CA
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1729
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from 91732
Chicago, IL
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2401
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from 91732
Hamilton, NJ
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2315
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from 91732
Hollywood, FL
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725
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from 91732
Idaho Falls, ID
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2008
mi
from 91732
Johnson City, TN
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2449
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from 91732
New Hyde Park, NY
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Olive Branch, Mississippi 38654
1599
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from 91732
Olive Branch, MS
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85
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from 91732
Palm Springs, CA
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343
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from 91732
Phoenix, AZ
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105
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from 91732
San Diego, CA
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939
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from 91732
Spokane, WA
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2304
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from 91732
West Palm Beach, FL
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