Add Glucokinase Activator to Target A1c

NCT ID: NCT02405260

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-09-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TTP399 400 mg

TTP399 once daily

Group Type: EXPERIMENTAL

TTP399 400 mg

Intervention Type: DRUG

once daily

TTP399 800 mg

TTP399 once daily

Group Type: EXPERIMENTAL

TTP399 800 mg

Intervention Type: DRUG

once daily

Sitagliptin 100 mg

Sitagliptin once daily

Group Type: ACTIVE_COMPARATOR

Sitagliptin 100 mg

Intervention Type: DRUG

once daily

Placebo

Placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

once daily

Interventions

TTP399 400 mg

once daily

Intervention Type: DRUG

TTP399 800 mg

once daily

Intervention Type: DRUG

Sitagliptin 100 mg

once daily

Intervention Type: DRUG

Placebo

once daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

vTv Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen Valcarce, Ph.D.

Role: STUDY_CHAIR

vTv Therapeutics

Locations

Mesa, Arizona, United States

Tuscon, Arizona, United States

Canoga Park, California, United States

Huntington Park, California, United States

Los Angeles, California, United States

West Hills, California, United States

Centennial, Colorado, United States

Littleton, Colorado, United States

Waterbury, Connecticut, United States

West Palm Beach, Florida, United States

Gurnee, Illinois, United States

Evansville, Indiana, United States

Rochester, Minnesota, United States

Greensboro, North Carolina, United States

Moncks Corner, South Carolina, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

Schertz, Texas, United States

Norfolk, Virginia, United States

Richland, Washington, United States

Countries

United States

Other Identifiers

TTP399-202

Identifier Type: -

Identifier Source: org_study_id