Skip to main content
OpenTrials
Completed

NCT Number: NCT02653599

A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes

This trial is a multi-center, randomized, double-blind, placebo-controlled parallel group, Phase 2 study in subjects with Type 2 diabetes mellitus on a stable dose of metformin to evaluate the safety and efficacy of TTP273 versus placebo glucose control and body weight following administration for 3 months.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Costa Mesa, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject has a 6 month diagnosis of Type 2 diabetes mellitus prior to screening and meets the American Diabetes Association (ADA) guidelines for Type 2 diabetes mellitus.
  • On a stable regimen of metformin monotherapy equivalent to at least 1000 mg/day for the last 3 months prior to screening.
  • Males. Females of non-childbearing potential.
  • Generally stable health without a history of major surgery or significant injuries within the last year and without an active infection.

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.
  • Participation in a clinical trial and receipt of an investigational product within 30 days.
  • 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 or contemplating such therapy during the trial.
  • Previous surgical treatment of obesity.
  • 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.
  • Use of other diabetic agents except metformin within 3 months prior to Screening.
  • History of pancreatitis.
  • Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to screening.
  • History of hemolytic anemia, chronic transfusion requirement or other condition rendering HbA1c results unreliable.
  • History of MEN-2 or family history of medullary thyroid cancer.
  • History or presence of clinically significant disease (other than Type 2 diabetes mellitus).

Treatment and study plan

TTP273

Drug

Placebo

Drug

Primary outcomes

  1. Change in HbA1c from baseline at 12 weeks

    Time frame: Day 1 to Week 12

Secondary outcomes

  1. Percentage of subjects who achieve HbA1c <7% at 12 weeks

    Time frame: Day 1 to Week 12

  2. Change in body weight from baseline at 12 weeks

    Time frame: Day 1 to Week 12

  3. Change in plasma glucose levels from baseline at 12 weeks

    Time frame: Day 1 to Week 12

  4. Change in lipid Levels from baseline at 12 weeks

    Time frame: Day 1 to Week 12

  5. Change in insulin levels from baseline at 12 weeks

    Time frame: Day 1 to Week 12

  6. Change in C-peptide levels from baseline at 12 weeks

    Time frame: Day 1 to Week 12

  7. Adverse Events

    Time frame: Day 1 to Week 14

  8. Blood Pressure

    Time frame: Day 1 to Week 14

  9. Electrocardiogram Parameters

    Time frame: Day 1 to Week 14

  10. Hematology

    Time frame: Day 1 to Week 14

  11. Blood Chemistry

    Time frame: Day 1 to Week 14

  12. Urinalysis

    Time frame: Day 1 to Week 14

  13. Pulse

    Time frame: Day 1 to Week 14

Other outcomes

  1. Change in glucagon levels from baseline at 12 weeks

    Time frame: Day 1 to Week 12

  2. Change in glucagon-like peptide-1 levels from baseline at 12 weeks

    Time frame: Day 1 to Week 12

Sponsors and collaborators

Lead sponsor

vTv Therapeutics

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Multi-Center Study to Evaluate the Efficacy and Safety of TTP273 Following 12 Weeks Administration in Subjects With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 12, 2016
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.