NCT02405260

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

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

Timeline
Completed

Started Mar 2015

Typical duration for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

20 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

March 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

March 27, 2015

Last Update Submit

February 9, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c (Glycosylated haemoglobin)

    Day 1 to Day 168

Secondary Outcomes (17)

  • HbA1c < 7% at 6 months

    Day 1 to Day 168

  • HbA1c < 6.5% at 6 months

    Day 1 to Day 168

  • Plasma Glucose Levels

    Day 1 to Day 168

  • Lipid Levels

    Day 1 to Day 168

  • Insulin Levels

    Day 1 to Day 168

  • +12 more secondary outcomes

Study Arms (4)

TTP399 400 mg

EXPERIMENTAL

TTP399 once daily

Drug: TTP399 400 mg

TTP399 800 mg

EXPERIMENTAL

TTP399 once daily

Drug: TTP399 800 mg

Sitagliptin 100 mg

ACTIVE COMPARATOR

Sitagliptin once daily

Drug: Sitagliptin 100 mg

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

TTP399 400 mgDRUG

once daily

TTP399 400 mg
TTP399 800 mgDRUG

once daily

TTP399 800 mg
Sitagliptin 100 mgDRUG

once daily

Sitagliptin 100 mg
PlaceboDRUG

once daily

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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.

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.
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Mesa, Arizona, 85213, United States

Location

Unknown Facility

Tuscon, Arizona, 85741, United States

Location

Unknown Facility

Canoga Park, California, 91303, United States

Location

Unknown Facility

Huntington Park, California, 90255, United States

Location

Unknown Facility

Los Angeles, California, 90056, United States

Location

Unknown Facility

West Hills, California, 91307, United States

Location

Unknown Facility

Centennial, Colorado, 80112, United States

Location

Unknown Facility

Littleton, Colorado, 80127, United States

Location

Unknown Facility

Waterbury, Connecticut, 06708, United States

Location

Unknown Facility

West Palm Beach, Florida, 33409, United States

Location

Unknown Facility

Gurnee, Illinois, 60031, United States

Location

Unknown Facility

Evansville, Indiana, 47725, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Greensboro, North Carolina, 27408, United States

Location

Unknown Facility

Moncks Corner, South Carolina, 29461, United States

Location

Unknown Facility

San Antonio, Texas, 78209, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Schertz, Texas, 78154, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

Unknown Facility

Richland, Washington, 99352, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

TTP399Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Carmen Valcarce, Ph.D.

    vTv Therapeutics

    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

March 27, 2015

First Posted

April 1, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

US(20)