Type 2 Diabetes MellitusPhase 2NCT02653599
A Study to Evaluate Safety and Efficacy of TTP273 for 12 Weeks in Subjects With Type 2 Diabetes
A Phase 2 study testing TTP273 in people with Type 2 Diabetes Mellitus, run by vTv Therapeutics at 30 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- TTP273
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 30 sitesUnited States
- Study dates
- Dec 2015to Jan 2017
- 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
- 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.
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.
- 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.
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- 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).
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Study site
Atlanta, Georgia, 30338
Study site
Cincinnati, Ohio, 45246
Study site
Corpus Christi, Texas, 78413
Study site
Costa Mesa, California, 92626
Study site
DeLand, Florida, 32720
Study site
Encino, California, 91436
Study site
Evanston, Illinois, 60201
Study site
Flint, Michigan, 48504
Study site
Greensboro, North Carolina, 27408
Study site
High Point, North Carolina, 27265
Study site
Houston, Texas, 77074
Study site
Humble, Texas, 77338
Study site
Huntington Park, California, 90255
Study site
Hurst, Texas, 76054
Study site
Katy, Texas, 77450
Study site
Los Angeles, California, 90057
Study site
Miami Lakes, Florida, 33014
Study site
Morehead City, North Carolina, 28557
Study site
Norman, Oklahoma, 73069
Study site
Norman, Oklahoma, 73072
Study site
Oakland, California, 94612
Study site
Omaha, Nebraska, 68114
Study site
Port Orange, Florida, 32129
Study site
Richland, Washington, 99352
Study site
Sacramento, California, 95821
Study site
San Antonio, Texas, 78209
Study site
San Antonio, Texas, 78229
Study site
Tampa, Florida, 33606
Study site
The Bronx, New York, 10459
Study site
West Palm Beach, Florida, 33401
About this study
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
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- TTP273, 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.
TTP273Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TTP273 300 mg daily (150 mg BID) | Experimental | Two 75 mg tablets of TTP273 administered orally twice daily for 12 weeks Receives: Drug: TTP273 |
| TTP273 150 mg daily | Experimental | Two 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks Receives: Drug: TTP273; Drug: Placebo |
| Placebo | Placebo comparator | Two matching placebo tablets administered orally twice daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline at 12 weeks
Measured: Day 1 to Week 12
Secondary outcomes (13)
Percentage of subjects who achieve HbA1c <7% at 12 weeks
Measured: Day 1 to Week 12
Change in body weight from baseline at 12 weeks
Measured: Day 1 to Week 12
Change in plasma glucose levels from baseline at 12 weeks
Measured: Day 1 to Week 12
Change in lipid Levels from baseline at 12 weeks
Measured: Day 1 to Week 12
Change in insulin levels from baseline at 12 weeks
Measured: Day 1 to Week 12
Change in C-peptide levels from baseline at 12 weeks
Measured: Day 1 to Week 12
Adverse Events
Measured: Day 1 to Week 14
Blood Pressure
Measured: Day 1 to Week 14
Electrocardiogram Parameters
Measured: Day 1 to Week 14
Hematology
Measured: Day 1 to Week 14
Blood Chemistry
Measured: Day 1 to Week 14
Urinalysis
Measured: Day 1 to Week 14
Pulse
Measured: Day 1 to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- vTv Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Freeman, Ph.D., Study chair, vTv Therapeutics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653599
- Sponsor's protocol ID
- TTP273-201
- Status last verified
- Feb 2017
- First submitted
- 8 Jan 2016
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02653599
- Acronym / sponsor ID
- TTP273-201
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- vTv TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TTP273 300 mg daily (150 mg BID) | Experimental | Drug: TTP273Two 75 mg tablets of TTP273 administered orally twice daily for 12 weeks |
| TTP273 150 mg daily | Experimental | Drug: TTP273, Drug: PlaceboTwo 75mg tablets of TTP273 administered orally once daily and two placebo tablets administered orally once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboTwo matching placebo tablets administered orally twice daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTP273 | Drug | TTP273 150 mg daily, TTP273 300 mg daily (150 mg BID) |
| Placebo | Drug | Placebo, TTP273 150 mg daily |
Primary outcome
Change in HbA1c from baseline at 12 weeks
Time frame: Day 1 to Week 12
13 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Freeman, Ph.D. study chair
vTv Therapeutics LLC
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTP273 in people with Type 2 Diabetes Mellitus, run by vTv Therapeutics at 30 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 4 inclusion and 11 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 30 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 from baseline at 12 weeks (time frame: Day 1 to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.