RECRUITING

Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.

Official Title

Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study

Quick Facts

Study Start:2024-06-14

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06334133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Individuals ≥18 years * 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	* 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) within 90 days prior to the Screening 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

Inclusion Criteria

Exclusion Criteria

* Individuals ≥18 years
* 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

* 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) within 90 days prior to the Screening 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

Contacts and Locations

Study Contact

Jennifer Freeman, Ph.D.

CONTACT

(336) 888-0435

clinicaltrials@vtvtherapeutics.com

Principal Investigator

Thomas Strack, MD

STUDY_DIRECTOR

vTv Therapeutics

Study Locations (Sites)

Advanced Metabolic Care & Research Institute, Inc. (AMCR)

Escondido, California, 92025

United States

Scripps Whittier Diabetes Institute

La Jolla, California, 92037

United States

Denver Endocrinology Diabetes and Thyroid Center

Englewood, Colorado, 80113

United States

ALL Medical Research, LLC

Cooper City, Florida, 33024

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

Endocrine Research Solutions, Inc

Roswell, Georgia, 30076

United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265

United States

Vector Clinical Trials

Sparks, Nevada, 89436

United States

Asheville Clinical Research

Asheville, North Carolina, 28803

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514

United States

Lucas Research, Inc

Morehead City, North Carolina, 28557

United States

Velocity Clinical Research - Medford

Medford, Oregon, 97504

United States

Texas Diabetes and Endocrinology, P.A

Austin, Texas, 78731

United States

Velocity Clinical Research - Dallas

Dallas, Texas, 75230

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

Advanced Research Institute - Ogden

Ogden, Utah, 84405

United States

Collaborators and Investigators

Sponsor: vTv Therapeutics

Thomas Strack, MD, STUDY_DIRECTOR, vTv Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-14

Study Completion Date2026-10

Study Record Updates

Study Start Date2024-06-14

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 1