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Diabetes Mellitus, Type 2Phase 2AGATANCT02405260

Add Glucokinase Activator to Target A1c

A Phase 2 study testing TTP399 400 mg, TTP399 800 mg and Sitagliptin 100 mg in people with Diabetes Mellitus, Type 2, run by vTv Therapeutics at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
TTP399 400 mg, TTP399 800 mg and Sitagliptin 100 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
190 participants
Where
20 sitesUnited States
Study dates
Mar 2015to Sep 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Study site

    Canoga Park, California, 91303

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Evansville, Indiana, 47725

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Gurnee, Illinois, 60031

  • Study site

    Huntington Park, California, 90255

  • Study site

    Littleton, Colorado, 80127

  • Study site

    Los Angeles, California, 90056

  • Study site

    Mesa, Arizona, 85213

  • Study site

    Moncks Corner, South Carolina, 29461

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Richland, Washington, 99352

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    San Antonio, Texas, 78209

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Schertz, Texas, 78154

  • Study site

    Tuscon, Arizona, 85741

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    West Hills, California, 91307

  • Study site

    West Palm Beach, Florida, 33409

Other trials in United States

About this study

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

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.

Being tested
TTP399 400 mg, TTP399 800 mg, Sitagliptin 100 mg, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TTP399 400 mgDrug

    once daily

  • TTP399 800 mgDrug

    once daily

  • Sitagliptin 100 mgDrug

    once daily

  • PlaceboDrug

    once daily

Study groups in NCT02405260
Study groupRoleWhat they receive
TTP399 400 mgExperimentalTTP399 once daily
Receives: Drug: TTP399 400 mg
TTP399 800 mgExperimentalTTP399 once daily
Receives: Drug: TTP399 800 mg
Sitagliptin 100 mgActive comparatorSitagliptin once daily
Receives: Drug: Sitagliptin 100 mg
PlaceboPlacebo comparatorPlacebo once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c (Glycosylated haemoglobin)

    Measured: Day 1 to Day 168

Secondary outcomes (17)

  1. HbA1c < 7% at 6 months

    Measured: Day 1 to Day 168

  2. HbA1c < 6.5% at 6 months

    Measured: Day 1 to Day 168

  3. Plasma Glucose Levels

    Measured: Day 1 to Day 168

  4. Lipid Levels

    Measured: Day 1 to Day 168

  5. Insulin Levels

    Measured: Day 1 to Day 168

  6. Lactate Levels

    Measured: Day 1 to Day 168

  7. C-peptide Levels

    Measured: Day 1 to Day 168

  8. Glucagon Levels

    Measured: Day 1 to Day 168

  9. Glucagon-like Peptide-1 Levels

    Measured: Day 1 to Day 168

  10. Change in Body Weight

    Measured: Day 1 to Day 168

  11. Adverse Events

    Measured: Day 1 to Day 182

  12. Blood Pressure

    Measured: Day 1 to Day 182

  13. Electrocardiogram Parameters

    Measured: Day 1 to Day 182

  14. Hematology

    Measured: Day 1 to Day 182

  15. Blood Chemistry

    Measured: Day 1 to Day 182

  16. Urinalysis

    Measured: Day 1 to Day 182

  17. Pulse

    Measured: Day 1 to Day 182

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionJul 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02405260
Sponsor's protocol ID
TTP399-202
Acronym
AGATA
Status last verified
Feb 2017
First submitted
27 Mar 2015
Last updated
10 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TTP399 400 mg, TTP399 800 mg and Sitagliptin 100 mg in people with Diabetes Mellitus, Type 2, run by vTv Therapeutics at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (Glycosylated haemoglobin) (time frame: Day 1 to Day 168). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02405260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.

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