Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGTTP273
DRUGPlacebo
Sponsors
vTv Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline at 12 weeks | Day 1 to Week 12 |
Secondary
| Measure | 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 |
| Urinalysis | Day 1 to Week 14 |
| Pulse | 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 |
Other
| Measure | Time frame |
|---|---|
| Change in glucagon levels from baseline at 12 weeks | Day 1 to Week 12 |
| Change in glucagon-like peptide-1 levels from baseline at 12 weeks | Day 1 to Week 12 |
Countries
United States
Outcome results
None listed