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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: TTP273

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92626
    • Encino, California, United States, 91436
    • Huntington Park, California, United States, 90255
    • Los Angeles, California, United States, 90057
    • Oakland, California, United States, 94612
    • Sacramento, California, United States, 95821
  • Florida
    • DeLand, Florida, United States, 32720
    • Miami Lakes, Florida, United States, 33014
    • Port Orange, Florida, United States, 32129
    • Tampa, Florida, United States, 33606
    • West Palm Beach, Florida, United States, 33401
  • Georgia
    • Atlanta, Georgia, United States, 30338
  • Illinois
    • Evanston, Illinois, United States, 60201
  • Michigan
    • Flint, Michigan, United States, 48504
  • Nebraska
    • Omaha, Nebraska, United States, 68114
  • New York
    • Bronx, New York, United States, 10459
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
    • High Point, North Carolina, United States, 27265
    • Morehead City, North Carolina, United States, 28557
  • Ohio
    • Cincinnati, Ohio, United States, 45246
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
    • Norman, Oklahoma, United States, 73072
  • Texas
    • Corpus Christi, Texas, United States, 78413
    • Houston, Texas, United States, 77074
    • Humble, Texas, United States, 77338
    • Hurst, Texas, United States, 76054
    • Katy, Texas, United States, 77450
    • San Antonio, Texas, United States, 78229
    • San Antonio, Texas, United States, 78209
  • Washington
    • Richland, Washington, United States, 99352

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TTP273 300 mg daily (150 mg BID); Two 75 mg tablets of TTP273 administered orally twice daily for 12 weeks	Drug: TTP273
Experimental: TTP273 150 mg daily; Two 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks	Drug: Placebo; Drug: TTP273
Placebo Comparator: Placebo; Two matching placebo tablets administered orally twice daily for 12 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c from baseline at 12 weeks	Day 1 to Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects who achieve HbA1c <7% at 12 weeks	Day 1 to Week 12
Change in body weight from baseline at 12 weeks	Day 1 to Week 12
Change in plasma glucose levels from baseline at 12 weeks	Day 1 to Week 12
Change in lipid Levels from baseline at 12 weeks	Day 1 to Week 12
Change in insulin levels from baseline at 12 weeks	Day 1 to Week 12
Change in C-peptide levels from baseline at 12 weeks	Day 1 to Week 12
Adverse Events	Day 1 to Week 14
Blood Pressure	Day 1 to Week 14
Electrocardiogram Parameters	Day 1 to Week 14
Hematology	Day 1 to Week 14
Blood Chemistry	Day 1 to Week 14
Urinalysis	Day 1 to Week 14
Pulse	Day 1 to Week 14

Other Outcome Measures

Outcome Measure	Time Frame
Change in glucagon levels from baseline at 12 weeks	Day 1 to Week 12
Change in glucagon-like peptide-1 levels from baseline at 12 weeks	Day 1 to Week 12

Collaborators and Investigators

• Sponsor: vTv Therapeutics
• Investigators: Study Chair: Jennifer Freeman, Ph.D., vTv Therapeutics LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: TTP273-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No