NCT02653599

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

January 8, 2016

Last Update Submit

February 9, 2017

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c from baseline at 12 weeks

    Day 1 to Week 12

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Other Outcomes (2)

  • 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

Study Arms (3)

TTP273 300 mg daily (150 mg BID)

EXPERIMENTAL

Two 75 mg tablets of TTP273 administered orally twice daily for 12 weeks

Drug: TTP273

TTP273 150 mg daily

EXPERIMENTAL

Two 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks

Drug: TTP273Drug: Placebo

Placebo

PLACEBO COMPARATOR

Two matching placebo tablets administered orally twice daily for 12 weeks

Drug: Placebo

Interventions

TTP273DRUG
TTP273 150 mg dailyTTP273 300 mg daily (150 mg BID)
PlaceboDRUG
PlaceboTTP273 150 mg daily

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Unknown Facility

Costa Mesa, California, 92626, United States

Location

Unknown Facility

Encino, California, 91436, United States

Location

Unknown Facility

Huntington Park, California, 90255, United States

Location

Unknown Facility

Los Angeles, California, 90057, United States

Location

Unknown Facility

Oakland, California, 94612, United States

Location

Unknown Facility

Sacramento, California, 95821, United States

Location

Unknown Facility

DeLand, Florida, 32720, United States

Location

Unknown Facility

Miami Lakes, Florida, 33014, United States

Location

Unknown Facility

Port Orange, Florida, 32129, United States

Location

Unknown Facility

Tampa, Florida, 33606, United States

Location

Unknown Facility

West Palm Beach, Florida, 33401, United States

Location

Unknown Facility

Atlanta, Georgia, 30338, United States

Location

Unknown Facility

Evanston, Illinois, 60201, United States

Location

Unknown Facility

Flint, Michigan, 48504, United States

Location

Unknown Facility

Omaha, Nebraska, 68114, United States

Location

Unknown Facility

The Bronx, New York, 10459, United States

Location

Unknown Facility

Greensboro, North Carolina, 27408, United States

Location

Unknown Facility

High Point, North Carolina, 27265, United States

Location

Unknown Facility

Morehead City, North Carolina, 28557, United States

Location

Unknown Facility

Cincinnati, Ohio, 45246, United States

Location

Unknown Facility

Norman, Oklahoma, 73069, United States

Location

Unknown Facility

Norman, Oklahoma, 73072, United States

Location

Unknown Facility

Corpus Christi, Texas, 78413, United States

Location

Unknown Facility

Houston, Texas, 77074, United States

Location

Unknown Facility

Humble, Texas, 77338, United States

Location

Unknown Facility

Hurst, Texas, 76054, United States

Location

Unknown Facility

Katy, Texas, 77450, United States

Location

Unknown Facility

San Antonio, Texas, 78209, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Richland, Washington, 99352, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jennifer Freeman, Ph.D.

    vTv Therapeutics LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 12, 2016

Study Start

December 1, 2015

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

US(30)