A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:2/11/2017
Start Date:August 2012
End Date:May 2013

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Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

The purpose of this study is to compare the safety and effect of TTP054 versus placebo on
glucose control in patients with type 2 diabetes.


Inclusion Criteria:

- Diagnosis of type 2 diabetes mellitus

- On a stable (for the last 3 months) regimen of either metformin alone or metformin in
combination with one additional acceptable oral antidiabetic (OAD) agent

- HbA1c: Metformin only: 7.0 - 11.0%; Metformin + acceptable OAD agent: 6.5 - 9.5%

Exclusion Criteria:

- History or evidence of significant diabetic complications

- History of heart attack, stroke or congestive heart failure

- Severe, uncontrolled hypertension

- Frequent hypoglycemia

- Women of child-bearing potential
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