Add Glucokinase Activator to Target A1c

Diabetes Mellitus, Type 2 Clinical Trial

— AGATA  

Official title:

A Multi-Center, Adaptive Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled (Sitagliptin), Parallel Group Study to Evaluate the Safety and Efficacy of TTP399 Following 6 Months Administration in Subjects With Type 2 Diabetes Mellitus on A Stable Dose of Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405260
• Other study ID #: TTP399-202
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2015
• Last updated: February 9, 2017
• Start date: March 2015
• Est. completion date: September 2016

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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

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.

• 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.

• 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.

• A history of excessive alcohol consumption within the last 2 years prior to screening

• Mental or legal incapacitation.

• Blood donation of approximately 1 pint (500 mL) within 8 weeks.

• History of MEN-2 or family history of medullary thyroid cancer.

• History of cancer, other than non-melanoma skin cancer, that required therapy in the 5 years prior study start.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• TTP399 400 mg
once daily
• TTP399 800 mg
once daily
• Sitagliptin 100 mg
once daily
• Placebo
once daily

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
Primary	Change in HbA1c (Glycosylated haemoglobin)		Day 1 to Day 168
Secondary	HbA1c < 7% at 6 months		Day 1 to Day 168
Secondary	HbA1c < 6.5% at 6 months		Day 1 to Day 168
Secondary	Plasma Glucose Levels		Day 1 to Day 168
Secondary	Lipid Levels		Day 1 to Day 168
Secondary	Insulin Levels		Day 1 to Day 168
Secondary	Lactate Levels		Day 1 to Day 168
Secondary	C-peptide Levels		Day 1 to Day 168
Secondary	Glucagon Levels		Day 1 to Day 168
Secondary	Glucagon-like Peptide-1 Levels		Day 1 to Day 168
Secondary	Change in Body Weight		Day 1 to Day 168
Secondary	Adverse Events		Day 1 to Day 182
Secondary	Blood Pressure		Day 1 to Day 182
Secondary	Electrocardiogram Parameters		Day 1 to Day 182
Secondary	Hematology		Day 1 to Day 182
Secondary	Blood Chemistry		Day 1 to Day 182
Secondary	Urinalysis		Day 1 to Day 182
Secondary	Pulse		Day 1 to Day 182