A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:2/11/2017
Start Date:December 2015
End Date:January 2017

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Multi-Center Study to Evaluate the Efficacy and Safety of TTP273 Following 12 Weeks Administration in Subjects With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

This trial is a multi-center, randomized, double-blind, placebo-controlled parallel group,
Phase 2 study in subjects with Type 2 diabetes mellitus on a stable dose of metformin to
evaluate the safety and efficacy of TTP273 versus placebo glucose control and body weight
following administration for 3 months.


Inclusion Criteria:

- The subject has a 6 month diagnosis of Type 2 diabetes mellitus prior to screening
and meets the American Diabetes Association (ADA) guidelines for Type 2 diabetes
mellitus.

- On a stable regimen of metformin monotherapy equivalent to at least 1000 mg/day for
the last 3 months prior to screening.

- Males. Females of non-childbearing potential.

- Generally stable health without a history of major surgery or significant injuries
within the last year and without an active infection.

Exclusion Criteria:

- Diagnosis of Type 1 diabetes mellitus, maturity-onset diabetes of the young,
insulin-requiring Type 2 Diabetes, other unusual or rare forms of diabetes mellitus,
or history of diabetic ketoacidosis.

- Participation in a clinical trial and receipt of an investigational product within 30
days.

- Participation in any formal weight loss program, or fluctuation of > 5% in body
weight, or having received medications approved for weight loss within 3 months prior
to screening or contemplating such therapy during the trial.

- Previous surgical treatment of obesity.

- Have a history of hypoglycemic episode requiring glucose, glucagon, or orange juice
administered by someone other than the patient within 6 months prior to screening.

- Use of other diabetic agents except metformin within 3 months prior to Screening.

- History of pancreatitis.

- Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to screening.

- History of hemolytic anemia, chronic transfusion requirement or other condition
rendering HbA1c results unreliable.

- History of MEN-2 or family history of medullary thyroid cancer.

- History or presence of clinically significant disease (other than Type 2 diabetes
mellitus).
We found this trial at
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Greensboro, North Carolina 27401
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Huntington Park, California 90255
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Morehead City, North Carolina 28557
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