A Study to Evaluate the Safety and Effectiveness of the Drug TTP399 to Target A1c in Type 2 Diabetics

Overview

About this study

This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active- controlled, parallel group, phase 2 study in subjects with Type 2 Diabetes Mellitus to evaluate the effect of TTP399 on HbA1c following administration for 6 months.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Adrian Vella, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

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Supplemental Study Information

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Additional contact information

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