Diabetes Mellitus, Type 1Phase 3CATT1NCT06334133
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
A Phase 3 study testing Cadisegliatin 800 mg QD and Cadisegliatin 800 mg BID in people with Diabetes Mellitus, Type 1, run by vTv Therapeutics at 48 sites in 2 countries.
Trial summary
This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Cadisegliatin 800 mg QD and Cadisegliatin 800 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 48 sitesin 2 countries
- Study dates
- 14 Jun 2024to May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals ≥18 years
- Diagnosed T1DM with a minimum of 3 years since diagnosis
- Has had at least 1 hypoglycemic event of Level 2 (glucose level <54 mg/dL or <3 mmol/L, [CGM or SMBG confirmed]) or Level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to Screening
- HbA1c value of <9.5% at Screening
- Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study
- Must have been on a CGM device for at least 3 months prior to Screening
Who cannot join
- Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease
- Has been hospitalized for DKA within 3 months prior to Screening
- Has uncontrolled hypothyroidism or hyperthyroidism
- History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight
- Has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ
- Has used any of the following medications within the specified time periods - any non-insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, or pramlintide, alpha-glucosidase inhibitors, or glucose-dependent insulinotropic polypeptide agonists) or weight loss medications within 30 days prior to the Screening
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- Has used a hybrid closed-loop system (e.g., Medtronic 670G, Omnipod 5, or Tandem X2 with control IQ) or Do-It-Yourself looping within the last 30 days prior to the Screening Visit, and agrees to not start hybrid closed-loop systems or Do-It-Yourself looping during the study.
- Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 utilizing the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening
- Has uncontrolled hypertension prior to Screening
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States47 sites
AMC Community Endocrinology
Albany, New York, 12203
Accellacare - McFarland
Ames, Iowa, 50010
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Texas Diabetes and Endocrinology, P.A
Austin, Texas, 78731
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239
Massachusetts General Hospital Diabetes Research Center
Boston, Massachusetts, 02114
Diabetes & Endocrinology Associates of Stark County, Inc
Canton, Ohio, 44718
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Javarra Inc.
Charlotte, North Carolina, 28210
BayCare Health Systems
Clearwater, Florida, 33756
Centricity Research - Columbus
Columbus, Georgia, 31904
John Muir Physician Network Clinical Research Center
Concord, California, 94520
Velocity Clinical Research - Dallas
Dallas, Texas, 75230
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, 80113
Profound Research LLC
Farmington Hills, Michigan, 48334
Amicis Research Center
Granada Hills, California, 91344
Physician's East PA
Greenville, North Carolina, 27834
AME Clinical Research
Huntington Beach, California, 92647
DM Clinical Research
Indianapolis, Indiana, 46254
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
IMAX Clinical Trials
La Palma, California, 90623
Excel Clinical Research
Las Vegas, Nevada, 89109
Palm Research Center
Las Vegas, Nevada, 89128
Johnson County Clin-Trials, LLC
Lenexa, Kansas, 66219
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
The Jones Center Clinical Research, LLC
Macon, Georgia, 31210
Tekton Research, LLC
McKinney, Texas, 75069
Velocity Clinical Research
Medford, Oregon, 97504
SMS Clinical Research LLC
Mesquite, Texas, 75149
Southern Endocrinology Associates PA
Mesquite, Texas, 75149
Paradigm Clinical Research - Modesto
Modesto, California, 95355
Centricity Research Morehead City Multispecialty
Morehead City, North Carolina, 28557
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Vector Clinical Trials
Reno, Nevada, 89511
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Paradigm Clinical Research Centers LLC
San Diego, California, 92108
Acclaim Clinical Research
San Diego, California, 92120
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
University of Washington Diabetes Institute
Seattle, Washington, 98109
Consano Clinical Research
Shavano Park, Texas, 78231
Circle Clinical Research
Sioux Falls, South Dakota, 57104
Jacobi Medical Center
The Bronx, New York, 10461
The Lundquist Institute
Torrance, California, 90502
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
Focus Clinical Research
West Hills, California, 91307
Metabolic Research Institute, Inc
West Palm Beach, Florida, 33413
About this study
Official title: Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study
This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.
Read the detailed description
Study TTP399-302 is a 26-week, Phase 3 trial designed to measure the relative efficacy of adjunctive treatment with cadisegliatin to reduce the incidence of Level 2 or Level 3 hypoglycemia in participants with Type 1 Diabetes Mellitus compared to placebo (insulin alone) over 26 weeks of continuous therapy.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Cadisegliatin 800 mg QD, Cadisegliatin 800 mg BID, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadisegliatin 800 mg QDDrug
Also called TTP399
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
Cadisegliatin 800 mg BIDDrug
Also called TTP399
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
PlaceboDrug
Placebo (insulin alone)
| Study group | Role | What they receive |
|---|---|---|
| Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD | Experimental | The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy. Receives: Drug: Cadisegliatin 800 mg QD |
| Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BID | Experimental | The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy. Receives: Drug: Cadisegliatin 800 mg BID |
| Placebo: 26 Week Double Blind Treatment Period | Placebo comparator | The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incidence of Level 2 or Level 3 hypoglycemia
Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo.
Measured: 26 weeks
Secondary outcomes (8)
To assess the change in HbA1c
Change from baseline in HbA1c in participants on cadisegliatin vs placebo.
Measured: 26 weeks
To assess the effects of treatment on CGM-based metrics for glycemic control
Change from baseline for time in, above or below target range of participants on cadisegliatin vs placebo
Measured: 26 weeks
To assess the effects of treatment on the incidence of diabetic ketoacidosis
Number of events of diabetic ketoacidosis participants on cadisegliatin vs placebo
Measured: 26 weeks
To assess the effects of treatment on insulin dosing
Change from baseline in average daily total insulin on cadisegliatin vs placebo
Measured: 18 weeks
To assess the effects of treatment on body weight
Change from baseline in mean body weight
Measured: 26 weeks
To assess the incidence of treatment emergent adverse events
Number of treatment emergent adverse events with cadisegliatin vs placebo
Measured: 26 weeks
To assess the incidence of treatment emergent adverse events leading to discontinuation
Number of treatment emergent adverse events leading to discontinuation with cadisegliatin vs placebo
Measured: 26 weeks
To assess the incidence of adverse events of special interest
Number of adverse events of special interests with cadisegliatin vs placebo
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start14 Jun 2024
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- vTv Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Strack, MD, Study director, vTv Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334133
- Sponsor's protocol ID
- TTP399-302
- Acronym
- CATT1
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study
- ClinicalTrials.gov ID
- NCT06334133
- Acronym / sponsor ID
- CATT1 / TTP399-302
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- vTv TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Mar 2024 (actual)
- 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 is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.
Detailed description
Study TTP399-302 is a 26-week, Phase 3 trial designed to measure the relative efficacy of adjunctive treatment with cadisegliatin to reduce the incidence of Level 2 or Level 3 hypoglycemia in participants with Type 1 Diabetes Mellitus compared to placebo (insulin alone) over 26 weeks of continuous therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD | Experimental | Drug: Cadisegliatin 800 mg QDThe main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy. |
| Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BID | Experimental | Drug: Cadisegliatin 800 mg BIDThe main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy. |
| Placebo: 26 Week Double Blind Treatment Period | Placebo comparator | Drug: PlaceboThe main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals ≥18 years
- Diagnosed T1DM with a minimum of 3 years since diagnosis
- Has had at least 1 hypoglycemic event of Level 2 (glucose level <54 mg/dL or <3 mmol/L, [CGM or SMBG confirmed]) or Level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to Screening
- HbA1c value of <9.5% at Screening
- Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study
Key exclusion criteria (9 listed)
- Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease
- Has been hospitalized for DKA within 3 months prior to Screening
- Has uncontrolled hypothyroidism or hyperthyroidism
- History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight
- Has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ
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 |
|---|---|---|
| Cadisegliatin 800 mg QDAlso: TTP399Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin. | Drug | Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD |
| Cadisegliatin 800 mg BIDAlso: TTP399Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin. | Drug | Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BID |
| PlaceboPlacebo (insulin alone) | Drug | Placebo: 26 Week Double Blind Treatment Period |
Primary outcome
Change in incidence of Level 2 or Level 3 hypoglycemia
Time frame: 26 weeks
Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo.
8 secondary outcomes
To assess the change in HbA1c
Time frame: 26 weeks
To assess the effects of treatment on CGM-based metrics for glycemic control
Time frame: 26 weeks
To assess the effects of treatment on the incidence of diabetic ketoacidosis
Time frame: 26 weeks
To assess the effects of treatment on insulin dosing
Time frame: 18 weeks
To assess the effects of treatment on body weight
Time frame: 26 weeks
To assess the incidence of treatment emergent adverse events
Time frame: 26 weeks
To assess the incidence of treatment emergent adverse events leading to discontinuation
Time frame: 26 weeks
To assess the incidence of adverse events of special interest
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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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.
Thomas Strack, MD study director
vTv Therapeutics
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cadisegliatin 800 mg QD and Cadisegliatin 800 mg BID in people with Diabetes Mellitus, Type 1, run by vTv Therapeutics at 48 sites in 2 countries.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 incidence of Level 2 or Level 3 hypoglycemia (time frame: 26 weeks). 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 2 Nov 2026.