Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active- controlled, parallel group, Phase 2 study in subjects with T2DM to evaluate the effect of TTP399 on HbA1c following administration for 6 months.
Interventions
DRUGTTP399 400 mg
once daily
DRUGTTP399 800 mg
once daily
once daily
DRUGPlacebo
once daily
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
* A historical diagnosis of Type 2 Diabetes in accordance with the American Diabetes Association (ADA) guidelines, with diagnosis at least 6 months prior to Screening. * On a stable (for the last 3 months prior to screening) regimen of metformin monotherapy equivalent of at least 1000 mg once daily. * Males, females of childbearing potential (must have a negative pregnancy test and be willing to comply with protocol contraception), and females of non-childbearing potential. * Age 18 to 75 years, inclusive, at the time of screening. * HbA1c ≥7.0% and ≤9.5%. * Generally stable health without active infection or history of major surgery or significant injuries within the last year.
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. * Clinically significant abnormal lab values including eGFR \<50ml/min/1.73m2, ALT, bilirubin or AST \>1.5 X ULN, hypokalemia or other clinically significant electrolyte abnormality. * History of myocardial infarction, unstable angina, coronary revascularization, stroke, or transient ischemic attack within 2 years of screening. * Presence of symptomatic congestive heart failure. * History of cardiac arrhythmias requiring treatment or prophylaxis with drugs or devices during the last 2 years or any history of atrial fibrillation or flutter beyond a single short-term episode (e.g., lasting 1-2 days). * History or presence of a 2nd degree or greater atrioventricular block in the absence of a pacemaker. * A 12-lead ECG, from screening or baseline demonstrating QTcF interval \>450 msec for males or \>47 msec for females. * A family or personal history of long QT syndrome. * History of pancreatitis. * Persistent, uncontrolled hypertension. * Presence of chronic active hepatitis (hepatitis B, hepatitis C, nonalcoholic steatohepatitis \[NASH\]) and/or known liver cirrhosis. * 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. * A positive pre-study drug screen. * Participation in a clinical trial and receipt of an investigational product within 30 days. * Have a history of drug abuse within 2 years of screening or a positive pre-screen drug screen. * 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. * A history of excessive alcohol consumption within the last 2 years prior to screening * Mental or legal incapacitation. * Blood donation of approximately 1 pint (500 mL) within 8 weeks. * History of MEN-2 or family history of medullary thyroid cancer. * History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (Glycosylated haemoglobin) | Day 1 to Day 168 |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c < 6.5% at 6 months | Day 1 to Day 168 |
| Plasma Glucose Levels | Day 1 to Day 168 |
| Lipid Levels | Day 1 to Day 168 |
| Insulin Levels | Day 1 to Day 168 |
| Lactate Levels | Day 1 to Day 168 |
| C-peptide Levels | Day 1 to Day 168 |
| Glucagon Levels | Day 1 to Day 168 |
| Glucagon-like Peptide-1 Levels | Day 1 to Day 168 |
| HbA1c < 7% at 6 months | Day 1 to Day 168 |
| Adverse Events | Day 1 to Day 182 |
| Blood Pressure | Day 1 to Day 182 |
| Electrocardiogram Parameters | Day 1 to Day 182 |
| Hematology | Day 1 to Day 182 |
| Blood Chemistry | Day 1 to Day 182 |
| Urinalysis | Day 1 to Day 182 |
| Pulse | Day 1 to Day 182 |
| Change in Body Weight | Day 1 to Day 168 |
Countries
United States
Outcome results
None listed