Clinical trial NCT02653599: A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: vTv Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-01-12
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in HbA1c from baseline at 12 weeks
timeFrame: Day 1 to Week 12
Secondary outcomes:
measure: Percentage of subjects who achieve HbA1c <7% at 12 weeks
timeFrame: Day 1 to Week 12
measure: Change in body weight from baseline at 12 weeks
timeFrame: Day 1 to Week 12
measure: Change in plasma glucose levels from baseline at 12 weeks
timeFrame: Day 1 to Week 12
measure: Change in lipid Levels from baseline at 12 weeks
timeFrame: Day 1 to Week 12
measure: Change in insulin levels from baseline at 12 weeks
timeFrame: Day 1 to Week 12
measure: Change in C-peptide levels from baseline at 12 weeks
timeFrame: Day 1 to Week 12
measure: Adverse Events
timeFrame: Day 1 to Week 14
measure: Blood Pressure
timeFrame: Day 1 to Week 14
measure: Electrocardiogram Parameters
timeFrame: Day 1 to Week 14
measure: Hematology
timeFrame: Day 1 to Week 14
measure: Blood Chemistry
timeFrame: Day 1 to Week 14
measure: Urinalysis
timeFrame: Day 1 to Week 14
measure: Pulse
timeFrame: Day 1 to Week 14
Other outcomes:
measure: Change in glucagon levels from baseline at 12 weeks
timeFrame: Day 1 to Week 12
measure: Change in glucagon-like peptide-1 levels from baseline at 12 weeks
timeFrame: Day 1 to Week 12
Locations:
city: Costa Mesa
country: United States
state: California
city: Encino
country: United States
state: California
city: Huntington Park
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oakland
country: United States
state: California
city: Sacramento
country: United States
state: California
city: DeLand
country: United States
state: Florida
city: Miami Lakes
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Evanston
country: United States
state: Illinois
city: Flint
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Bronx
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Morehead City
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Norman
country: United States
state: Oklahoma
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Humble
country: United States
state: Texas
city: Hurst
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richland
country: United States
state: Washington
Study officials:
affiliation: vTv Therapeutics LLC
name: Jennifer Freeman, Ph.D.
role: STUDY_CHAIR
References: