Add Glucokinase Activator to Target A1c
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 2/11/2017 |
Start Date: | March 2015 |
End Date: | September 2016 |
A Multi-Center, Adaptive Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled (Sitagliptin), Parallel Group Study to Evaluate the Safety and Efficacy of TTP399 Following 6 Months Administration in Subjects With Type 2 Diabetes Mellitus on A Stable Dose of Metformin
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.
controlled, parallel group, Phase 2 study in subjects with T2DM to evaluate the effect of
TTP399 on HbA1c following administration for 6 months.
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.
We found this trial at
20
sites
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