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Using cadisegliatin with insulin for Type 1 Diabetes management

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

PHASE3 · vTv Therapeutics · NCT06334133

This study is testing if adding a new medication called cadisegliatin to insulin can help people with Type 1 Diabetes reduce severe low blood sugar episodes.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorvTv Therapeutics (industry)
Locations58 sites (Scottsdale, Arizona and 57 other locations)
Trial IDNCT06334133 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial evaluates the effectiveness of cadisegliatin as an additional treatment alongside insulin for individuals with Type 1 Diabetes Mellitus. Over a 26-week period, participants will receive either cadisegliatin or a placebo to determine its impact on reducing the occurrence of severe hypoglycemic events. Eligible participants must have a history of hypoglycemia and be on a stable insulin regimen. The study aims to provide insights into the safety and efficacy of this adjunctive therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of Type 1 Diabetes for at least 5 years and a history of recent hypoglycemic events.

Not a fit: Patients with Type 2 Diabetes or other rare forms of diabetes will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of severe hypoglycemia in patients with Type 1 Diabetes.

How similar studies have performed: Other studies have shown promising results with adjunctive therapies for Type 1 Diabetes, but the specific use of cadisegliatin is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Scottsdale, Arizona and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diabetes Mellitus, Type 1

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.