A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:8/3/2016
Start Date:May 2009
End Date:November 2010

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A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea

This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and
tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus
inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin
combination therapy. After an initial screening period, patients will be randomized to one
of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4
weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of
pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the
target sample size is 500+ individuals.


Inclusion Criteria:

- adult patients, 18-75 years of age;

- type 2 diabetes mellitus;

- treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12
weeks prior to screening;

- HbA1c >=7.0% and <=10% at screening;

- stable weight +/-5% for >=12 weeks prior to screening.

Exclusion Criteria:

- type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of
diabetes;

- clinically significant diabetic complications;

- clinically symptomatic gastrointestinal disease;

- >3 episodes of severe hypoglycemia within 6 months before screening.
We found this trial at
56
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569
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Houston, TX
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Atlanta, GA
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Ayer, MA
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Beaver, PA
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Bend, OR
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Berlin, NJ
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Bethesda, MD
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Biloxi, MS
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Brick, NJ
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Buena Park, CA
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8650
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Camperdown,
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610
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Chicago, IL
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Chiefland, FL
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1139
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Chino, CA
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Columbus, GA
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823
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Conyers, GA
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Coral Gables, FL
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349
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Dallas, TX
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Daytona Beach, FL
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1051
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Durham, NC
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559
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Evansville, IN
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635
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Fargo, ND
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840
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Ferndale, MI
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221
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Grand Island, NE
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571
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Jackson, MS
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843
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Kingsport, TN
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1168
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Los Angeles, CA
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565
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Madisonville, KY
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1355
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Medford, OR
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690
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Metairie, LA
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552
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Minneapolis, MN
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Mooresville, North Carolina 28117
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Mooresville, NC
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1290
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New York, NY
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Olive Branch, Mississippi 38654
484
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Olive Branch, MS
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Panama City, FL
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1225
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Philadelphia, PA
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Port Charlotte, FL
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Rancho Cucamonga, California 91730
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Rancho Cucamonga, CA
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1111
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Richmond, VA
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Roseville, CA
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Roswell, GA
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Salt Lake City, UT
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Santa Ana, CA
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Scranton, PA
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South Burlington, Vermont 05403
1357
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South Burlington, VT
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1201
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Spokane, WA
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Springfield, IL
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St Petersburg, FL
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Staten Island, NY
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Toms River, NJ
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Trenton, NJ
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1385
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Vancouver, WA
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Waltham, MA
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Waukesha, WI
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Winston-Salem, NC
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1140
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Winter Park, FL
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