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

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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.


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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mi
from
Norfolk, VA
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from
Canoga Park, CA
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from
Centennial, CO
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mi
from
Evansville, IN
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Greensboro, North Carolina 27401
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from
Greensboro, NC
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mi
from
Gurnee, IL
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Huntington Park, California 90255
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mi
from
Huntington Park, CA
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mi
from
Littleton, CO
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mi
from
Los Angeles, CA
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mi
from
Mesa, AZ
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Moncks Corner, South Carolina 29461
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mi
from
Moncks Corner, SC
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mi
from
Richland, WA
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mi
from
Rochester, MN
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mi
from
San Antonio, TX
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mi
from
San Antonio, TX
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mi
from
Schertz, TX
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mi
from
Tuscon, AZ
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mi
from
Waterbury, CT
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mi
from
West Hills, CA
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mi
from
West Palm Beach, FL
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