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 |
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.
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
29
sites
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