Add Glucokinase Activator to Target A1c (AGATA)

February 9, 2017 updated by: vTv Therapeutics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85213
      • Tuscon, Arizona, United States, 85741
    • California
      • Canoga Park, California, United States, 91303
      • Huntington Park, California, United States, 90255
      • Los Angeles, California, United States, 90056
      • West Hills, California, United States, 91307
    • Colorado
      • Centennial, Colorado, United States, 80112
      • Littleton, Colorado, United States, 80127
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
    • Florida
      • West Palm Beach, Florida, United States, 33409
    • Illinois
      • Gurnee, Illinois, United States, 60031
    • Indiana
      • Evansville, Indiana, United States, 47725
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
    • South Carolina
      • Moncks Corner, South Carolina, United States, 29461
    • Texas
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78209
      • Schertz, Texas, United States, 78154
    • Virginia
      • Norfolk, Virginia, United States, 23507
    • Washington
      • Richland, Washington, United States, 99352

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
once daily
Experimental: TTP399 400 mg
TTP399 once daily
Drug: TTP399 400 mg
once daily
Experimental: TTP399 800 mg
TTP399 once daily
Drug: TTP399 800 mg
once daily
Active Comparator: Sitagliptin 100 mg
Sitagliptin once daily
Drug: Sitagliptin 100 mg
once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in HbA1c (Glycosylated haemoglobin)
Time Frame: Day 1 to Day 168
Day 1 to Day 168

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
HbA1c < 7% at 6 months
Time Frame: Day 1 to Day 168
Day 1 to Day 168
HbA1c < 6.5% at 6 months
Time Frame: Day 1 to Day 168
Day 1 to Day 168
Plasma Glucose Levels
Time Frame: Day 1 to Day 168
Day 1 to Day 168
Lipid Levels
Time Frame: Day 1 to Day 168
Day 1 to Day 168
Insulin Levels
Time Frame: Day 1 to Day 168
Day 1 to Day 168
Lactate Levels
Time Frame: Day 1 to Day 168
Day 1 to Day 168
C-peptide Levels
Time Frame: Day 1 to Day 168
Day 1 to Day 168
Glucagon Levels
Time Frame: Day 1 to Day 168
Day 1 to Day 168
Glucagon-like Peptide-1 Levels
Time Frame: Day 1 to Day 168
Day 1 to Day 168
Change in Body Weight
Time Frame: Day 1 to Day 168
Day 1 to Day 168
Adverse Events
Time Frame: Day 1 to Day 182
Day 1 to Day 182
Blood Pressure
Time Frame: Day 1 to Day 182
Day 1 to Day 182
Electrocardiogram Parameters
Time Frame: Day 1 to Day 182
Day 1 to Day 182
Hematology
Time Frame: Day 1 to Day 182
Day 1 to Day 182
Blood Chemistry
Time Frame: Day 1 to Day 182
Day 1 to Day 182
Urinalysis
Time Frame: Day 1 to Day 182
Day 1 to Day 182
Pulse
Time Frame: Day 1 to Day 182
Day 1 to Day 182

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
vTv Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Carmen Valcarce, Ph.D., vTv Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TTP399-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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