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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02653599
• Other study ID #: TTP273-201
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2016
• Last updated: February 9, 2017
• Start date: December 2015
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: vTv Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• TTP273

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
vTv Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in glucagon levels from baseline at 12 weeks		Day 1 to Week 12
Other	Change in glucagon-like peptide-1 levels from baseline at 12 weeks		Day 1 to Week 12
Primary	Change in HbA1c from baseline at 12 weeks		Day 1 to Week 12
Secondary	Percentage of subjects who achieve HbA1c <7% at 12 weeks		Day 1 to Week 12
Secondary	Change in body weight from baseline at 12 weeks		Day 1 to Week 12
Secondary	Change in plasma glucose levels from baseline at 12 weeks		Day 1 to Week 12
Secondary	Change in lipid Levels from baseline at 12 weeks		Day 1 to Week 12
Secondary	Change in insulin levels from baseline at 12 weeks		Day 1 to Week 12
Secondary	Change in C-peptide levels from baseline at 12 weeks		Day 1 to Week 12
Secondary	Adverse Events		Day 1 to Week 14
Secondary	Blood Pressure		Day 1 to Week 14
Secondary	Electrocardiogram Parameters		Day 1 to Week 14
Secondary	Hematology		Day 1 to Week 14
Secondary	Blood Chemistry		Day 1 to Week 14
Secondary	Urinalysis		Day 1 to Week 14
Secondary	Pulse		Day 1 to Week 14