Type 1 Diabetes study: Cadisegliatin
Official title Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems
ClinicalTrials.gov ID: NCT07616206
What this study is testing
What is Cadisegliatin 800 mg QD?
Cadisegliatin 800 mg QD is an investigational medicine, taken by mouth, being studied as a potential treatment for type 1 diabetes (t1d).
Also referred to as TTP399.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- TTP399-206 is a Phase 2a cross over study of cadisegliatin in people with T1D using hybrid closed loop systems to manage their diabetes.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a...
- 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
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Modesto, California, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Chapel Hill, North Carolina, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Modesto, California, United States; San Diego, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Chapel Hill, North Carolina, United States; Austin, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.