Cadisegliatin added to insulin in adults with Type 1 diabetes using hybrid closed loop systems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2a, multicenter, double-blind, cross-over trial in adults with Type 1 diabetes using hybrid closed-loop systems. Participants will receive cadisegliatin 800 mg or placebo daily in two 6-week treatment periods separated by a 2-week washout, with a screen and device training beforehand. The study aims to gather preliminary data on efficacy and safety of cadisegliatin in an HCL setting. A total of 20 weeks of participation includes device wear, CGM use, and insulin adjustments. Primary outcomes will inform potential effects on glycemic control and safety in this population.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Participants \>= 18 years of age
* Fasting C-peptide levels \<0.6 ng/ml
* Average TIR \< 70% recorded on their personal CGM data collected over the past 7 days prior to Visit 1
* Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration
* Willing to wear a study provided CGM for study duration
* Total bilirubin ≤2×ULN, ALT and AST ≤3×ULN

Key Exclusion Criteria:

* Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease.
* Have been hospitalized for DKA within 3 months
* Have uncontrolled hypothyroidism or hyperthyroidism
* Have QTcF interval \> 450 msec for males or \> 470 msec for females
* Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias
* Have persistent, uncontrolled hypertension
* Have clinically significant cardiovascular or cerebrovascular disease
* Have proliferative retinopathy or maculopathy requiring acute treatment
* Have a serious concomitant systemic disorder including but not limited to HIV or active Hep B or Hep C
* Have been diagnosed and/or treated for malignancy within 3 years
* Have used any of the following medications within the specified time periods: any non-insulin anti-diabetic therapies (e.g.SGLT-2 inhibitors, GLP-1 receptor agonists, metformin, sulfonylureas, DPP-4 inhibitors, pramlintide, a-glucosidase inhibitors, or glucose dependent insulinotropic polypeptide agonists) within 30 days, antipsychotic medications (e.g. olanzapine, risperidone, clozapine, quetiapine, and haloperidol) within 30 days, systemic corticosteroids for ≥7 days for a temporary medical condition within 30 days,

Where it's running

• Paradigm Clinical Research -Modesto
  Modesto, California, United States Recruiting
• Paradigm Clinical Research Centers, LLC
  San Diego, California, United States Recruiting
• Barbara Davis Center for Diabetes
  Aurora, Colorado, United States Recruiting
• Atlanta Diabetes Associates
  Atlanta, Georgia, United States Recruiting
• UNC Eastowne Medical Office Building
  Chapel Hill, North Carolina, United States Recruiting
• Texas Diabetes & Endocrinology, P.A.
  Austin, Texas, United States Recruiting

Study contacts

• Study coordinator: Meaghan Marnell
• Email: clinicaltrials@vtvtherapeutics.com
• Phone: (336) 888-0435

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.