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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
TTP273 150 mg daily	Placebo	Two 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks
Placebo	Placebo	Two matching placebo tablets administered orally twice daily for 12 weeks
TTP273 300 mg daily (150 mg BID)	TTP273	Two 75 mg tablets of TTP273 administered orally twice daily for 12 weeks
TTP273 150 mg daily	TTP273	Two 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline at 12 weeks	Day 1 to Week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects who achieve HbA1c <7% at 12 weeks	Day 1 to Week 12
Adverse Events	Day 1 to Week 14
Change in insulin levels from baseline at 12 weeks	Day 1 to Week 12
Electrocardiogram Parameters	Day 1 to Week 14
Urinalysis	Day 1 to Week 14
Change in body weight from baseline at 12 weeks	Day 1 to Week 12
Change in plasma glucose levels from baseline at 12 weeks	Day 1 to Week 12
Pulse	Day 1 to Week 14
Change in lipid Levels from baseline at 12 weeks	Day 1 to Week 12
Change in C-peptide levels from baseline at 12 weeks	Day 1 to Week 12
Blood Chemistry	Day 1 to Week 14
Blood Pressure	Day 1 to Week 14
Hematology	Day 1 to Week 14