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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653599
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
vTv Therapeutics

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: TTP273 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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: TTP273
Drug: Placebo
Placebo Comparator: Placebo
Two matching placebo tablets administered orally twice daily for 12 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Change in HbA1c from baseline at 12 weeks [ Time Frame: Day 1 to Week 12 ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653599


Locations
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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
United States, 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
United States, Georgia
Atlanta, Georgia, United States, 30338
United States, Illinois
Evanston, Illinois, United States, 60201
United States, Michigan
Flint, Michigan, United States, 48504
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, New York
Bronx, New York, United States, 10459
United States, North Carolina
Greensboro, North Carolina, United States, 27408
High Point, North Carolina, United States, 27265
Morehead City, North Carolina, United States, 28557
United States, Ohio
Cincinnati, Ohio, United States, 45246
United States, Oklahoma
Norman, Oklahoma, United States, 73069
Norman, Oklahoma, United States, 73072
United States, 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, 78209
San Antonio, Texas, United States, 78229
United States, Washington
Richland, Washington, United States, 99352
Sponsors and Collaborators
vTv Therapeutics
Investigators
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Study Chair: Jennifer Freeman, Ph.D. vTv Therapeutics LLC
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Responsible Party: vTv Therapeutics
ClinicalTrials.gov Identifier: NCT02653599    
Other Study ID Numbers: TTP273-201
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases