Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
NCT ID: NCT06334133
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2024-06-14
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD
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.
Cadisegliatin 800 mg QD
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BID
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.
Cadisegliatin 800 mg BID
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
Placebo: 26 Week Double Blind Treatment Period
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.
Placebo
Placebo (insulin alone)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cadisegliatin 800 mg QD
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
Cadisegliatin 800 mg BID
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
Placebo
Placebo (insulin alone)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosed T1DM with a minimum of 5 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 used a CGM device for at least 3 consecutive months prior to Screening
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
vTv Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Strack, MD
Role: STUDY_DIRECTOR
vTv Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Advanced Metabolic Care & Research Institute, Inc. (AMCR)
Escondido, California, United States
MD Studies, Inc
Fountain Valley, California, United States
AME Clinical Research
Huntington Beach, California, United States
Scripps Whittier Diabetes Institute
La Jolla, California, United States
Paradigm Clinical Research - Modesto
Modesto, California, United States
Paradigm Clinical Research Centers LLC
San Diego, California, United States
Focus Clinical Research
West Hills, California, United States
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
Excellence Medical and Research
Miami Gardens, Florida, United States
Metabolic Research Institute, Inc
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
East Coast Institute for Research, LLC
Canton, Georgia, United States
Centricity Research - Columbus
Columbus, Georgia, United States
The Jones Center Clinical Research, LLC
Macon, Georgia, United States
Endocrine Research Solutions, Inc
Roswell, Georgia, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Profound Research LLC
Farmington Hills, Michigan, United States
Palm Research Center
Las Vegas, Nevada, United States
Vector Clinical Trials
Sparks, Nevada, United States
Jacobi Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Lucas Research, Inc
Morehead City, North Carolina, United States
Diabetes & Endocrinology Associates of Stark County, Inc
Canton, Ohio, United States
Velocity Clinical Research - Medford
Medford, Oregon, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Texas Diabetes and Endocrinology, P.A
Austin, Texas, United States
Velocity Clinical Research - Dallas
Dallas, Texas, United States
Southern Endocrinology Associates PA
Mesquite, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
Advanced Research Institute - Ogden
Ogden, Utah, United States
University of Washington Diabetes Institute
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
T1D Exchange prescreening website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TTP399-302
Identifier Type: -
Identifier Source: org_study_id