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Cadisegliatin for Type 1 Diabetes

This study is testing a new medication called cadisegliatin for people with Type 1 Diabetes. Cadisegliatin is an oral medication that works alongside your insulin. Researchers want to see if taking cadisegliatin (either 800 mg once a day or 800 mg twice a day) can help reduce how often you experience low blood sugar (hypoglycemia) compared to taking insulin alone. You might be able to join if you are at least 18 years old, have had Type 1 Diabetes for at least three years, and have experienced at least one significant low blood sugar event in the past two months. The study aims to enroll about 150 participants. The current status of this study is unclear.

Study design
This is a Phase 3 interventional study comparing cadisegliatin to a placebo (insulin alone) in about 150 participants.
What's involved
You would take cadisegliatin or a placebo for 26 weeks. The record does not specify other visits or procedures.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 26 weeks, which suggests the study duration for treatment and observation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06334133

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
vTv Therapeutics
~150 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Cadisegliatin 800 mg QDCadisegliatin 800 mg BIDPlacebo

At a glance

Recruiting sites
0 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in incidence of Level 2 or Level 3 hypoglycemia
Measured over 26 weeks

Conditions

Diabetes Mellitus, Type 1

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

52 sites across 24 states
California10
Texas7
North Carolina4
Georgia3
Nevada3
Washington3
Florida2
Iowa2

Study leadership

  • Thomas Strack, MD · STUDY_DIRECTOR · vTv Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in incidence of Level 2 or Level 3 hypoglycemia26 weeks

    Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo.