NCT Number: NCT02653599
A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes
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.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Costa Mesa, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Placebo
DrugPrimary outcomes
-
Change in HbA1c from baseline at 12 weeks
Time frame: Day 1 to Week 12
Secondary outcomes
-
Percentage of subjects who achieve HbA1c <7% at 12 weeks
Time frame: Day 1 to Week 12
-
Change in body weight from baseline at 12 weeks
Time frame: Day 1 to Week 12
-
Change in plasma glucose levels from baseline at 12 weeks
Time frame: Day 1 to Week 12
-
Change in lipid Levels from baseline at 12 weeks
Time frame: Day 1 to Week 12
-
Change in insulin levels from baseline at 12 weeks
Time frame: Day 1 to Week 12
-
Change in C-peptide levels from baseline at 12 weeks
Time frame: Day 1 to Week 12
-
Adverse Events
Time frame: Day 1 to Week 14
-
Blood Pressure
Time frame: Day 1 to Week 14
-
Electrocardiogram Parameters
Time frame: Day 1 to Week 14
-
Hematology
Time frame: Day 1 to Week 14
-
Blood Chemistry
Time frame: Day 1 to Week 14
-
Urinalysis
Time frame: Day 1 to Week 14
-
Pulse
Time frame: Day 1 to Week 14
Other outcomes
-
Change in glucagon levels from baseline at 12 weeks
Time frame: Day 1 to Week 12
-
Change in glucagon-like peptide-1 levels from baseline at 12 weeks
Time frame: Day 1 to Week 12
Sponsors and collaborators
Lead sponsor
vTv Therapeutics
Industry
Registry information
Official study 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
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2017
- First posted
- Jan 12, 2016
- Registry last updated
- Feb 10, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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