Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
CATT1
1 other identifier
interventional
150
2 countries
52
Brief Summary
This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2024
Typical duration for phase_3
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 27, 2024
CompletedStudy Start
First participant enrolled
June 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
July 28, 2026
July 1, 2026
2.8 years
March 13, 2024
July 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
26 weeks
Secondary Outcomes (8)
To assess the change in HbA1c
26 weeks
To assess the effects of treatment on CGM-based metrics for glycemic control
26 weeks
To assess the effects of treatment on the incidence of diabetic ketoacidosis
26 weeks
To assess the effects of treatment on insulin dosing
18 weeks
To assess the effects of treatment on body weight
26 weeks
- +3 more secondary outcomes
Study Arms (3)
Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD
EXPERIMENTALThe 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
EXPERIMENTALThe 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 COMPARATORThe 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.
Interventions
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- vTv Therapeuticslead
Study Sites (52)
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Amicis Research Center
Granada Hills, California, 91344, United States
AME Clinical Research
Huntington Beach, California, 92647, United States
310 Clinical Research
Inglewood, California, 90301, United States
Scripps Whittier Diabetes Institute
La Jolla, California, 92037, United States
IMAX Clinical Trials
La Palma, California, 90623, United States
Paradigm Clinical Research - Modesto
Modesto, California, 95355, United States
Paradigm Clinical Research Centers LLC
San Diego, California, 92108, United States
Acclaim Clinical Research
San Diego, California, 92120, United States
The Lundquist Institute
Torrance, California, 90502, United States
Focus Clinical Research
West Hills, California, 91307, United States
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, 80113, United States
BayCare Health Systems
Clearwater, Florida, 33756, United States
Metabolic Research Institute, Inc
West Palm Beach, Florida, 33413, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Centricity Research - Columbus
Columbus, Georgia, 31904, United States
The Jones Center Clinical Research, LLC
Macon, Georgia, 31210, United States
Paradigm Clinical Research
Boise, Idaho, 83709, United States
DM Clinical Research
Indianapolis, Indiana, 46254, United States
Accellacare - McFarland
Ames, Iowa, 50010, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Johnson County Clin-Trials, LLC
Lenexa, Kansas, 66219, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239, United States
Massachusetts General Hospital Diabetes Research Center
Boston, Massachusetts, 02114, United States
Profound Research LLC
Farmington Hills, Michigan, 48334, United States
Excel Clinical Research
Las Vegas, Nevada, 89109, United States
Palm Research Center
Las Vegas, Nevada, 89128, United States
Vector Clinical Trials
Reno, Nevada, 89511, United States
AMC Community Endocrinology
Albany, New York, 12203, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Javarra Inc.
Charlotte, North Carolina, 28210, United States
Physician's East PA
Greenville, North Carolina, 27834, United States
Centricity Research Morehead City Multispecialty
Morehead City, North Carolina, 28557, United States
Diabetes & Endocrinology Associates of Stark County, Inc
Canton, Ohio, 44718, United States
John Muir Physician Network Clinical Research Center
Concord, Ohio, 94520, United States
Velocity Clinical Research
Medford, Oregon, 97504, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Circle Clinical Research
Sioux Falls, South Dakota, 57104, United States
Texas Diabetes and Endocrinology, P.A
Austin, Texas, 78731, United States
Velocity Clinical Research - Dallas
Dallas, Texas, 75230, United States
Tekton Research, LLC
McKinney, Texas, 75069, United States
SMS Clinical Research LLC
Mesquite, Texas, 75149, United States
Southern Endocrinology Associates PA
Mesquite, Texas, 75149, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229, United States
Consano Clinical Research
Shavano Park, Texas, 78231, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
University of Washington Diabetes Institute
Seattle, Washington, 98109, United States
Citta Clinical Research, LLC
Spokane, Washington, 99202, United States
Velocity Clinical Research - Spokane
Spokane, Washington, 99218, United States
Solace Clinical Research
San Juan, 00907, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Strack, MD
vTv Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2024
First Posted
March 27, 2024
Study Start
June 14, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
July 28, 2026
Record last verified: 2026-07