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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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

Key facts

Study ID

NCT06334133

Run by

vTv Therapeutics

People needed

150

Starts

2024-06-14

Expected to finish

2027-05-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Amicis Research Center — Granada Hills, California, United States
• AME Clinical Research — Huntington Beach, California, United States
• 310 Clinical Research — Inglewood, California, United States
• Scripps Whittier Diabetes Institute — La Jolla, California, United States
• IMAX Clinical Trials — La Palma, California, United States
• Paradigm Clinical Research - Modesto — Modesto, California, United States
• Paradigm Clinical Research Centers LLC — San Diego, California, United States
• Acclaim Clinical Research — San Diego, California, United States
• The Lundquist Institute — Torrance, California, United States
• Focus Clinical Research — West Hills, California, United States
• Denver Endocrinology Diabetes and Thyroid Center — Englewood, Colorado, United States
• BayCare Health Systems — Clearwater, Florida, United States
• Metabolic Research Institute, Inc — West Palm Beach, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Centricity Research - Columbus — Columbus, Georgia, United States
• The Jones Center Clinical Research, LLC — Macon, Georgia, United States
• Paradigm Clinical Research — Boise, Idaho, United States
• DM Clinical Research — Indianapolis, Indiana, United States
• Accellacare - McFarland — Ames, Iowa, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Johnson County Clin-Trials, LLC — Lenexa, Kansas, United States
• MedStar Good Samaritan Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital Diabetes Research Center — Boston, Massachusetts, United States
• Scottsdale Clinical Trials — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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