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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02653599

Run by

vTv Therapeutics

People needed

174

Starts

2015-12-01

Expected to finish

2017-01-01

Last updated by the study team

2017-02-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Study site — Costa Mesa, California, United States
• Study site — Encino, California, United States
• Study site — Huntington Park, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — Sacramento, California, United States
• Study site — DeLand, Florida, United States
• Study site — Miami Lakes, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Evanston, Illinois, United States
• Study site — Flint, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — The Bronx, New York, United States
• Study site — Greensboro, North Carolina, United States
• Study site — High Point, North Carolina, United States
• Study site — Morehead City, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Norman, Oklahoma, United States
• Study site — Norman, Oklahoma, United States
• Study site — Corpus Christi, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Humble, Texas, United States

Full record on ClinicalTrials.gov

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