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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: TTP273
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TTP273 300 mg daily (150 mg BID)<br>Two 75 mg tablets of TTP273 administered orally twice daily for 12 weeks | Drug: TTP273<br> <br> |
| Experimental: TTP273 150 mg daily<br>Two 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks | Drug: TTP273<br> <br> Drug: Placebo<br> <br> |
| Placebo Comparator: Placebo<br>Two matching placebo tablets administered orally twice daily for 12 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline at 12 weeks |  | Day 1 to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who achieve HbA1c <7% at 12 weeks |  | Day 1 to Week 12 | 
| 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 | 
| Change in lipid Levels from baseline at 12 weeks |  | Day 1 to Week 12 | 
| Change in insulin 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 | 
| Adverse Events |  | Day 1 to Week 14 | 
| Blood Pressure |  | Day 1 to Week 14 | 
| Electrocardiogram Parameters |  | Day 1 to Week 14 | 
| Hematology |  | Day 1 to Week 14 | 
| Blood Chemistry |  | Day 1 to Week 14 | 
| Urinalysis |  | Day 1 to Week 14 | 
| Pulse |  | Day 1 to Week 14 |