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 |
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.
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
sites
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