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
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Mooresville, North Carolina 28117
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Olive Branch, Mississippi 38654
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Rancho Cucamonga, California 91730
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South Burlington, Vermont 05403
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