Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems
Hybrid CATT1: Hybrid Closed Loop Insulin Pumps With Cadisegliatin as Adjunctive Treatment in Patients With Type 1 Diabetes A Phase 2a Double Blind Randomized Cross-Over Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests cadisegliatin added to insulin in adults with type 1 diabetes who use a hybrid closed loop insulin pump system. Participants take cadisegliatin once a day for 6 weeks and a placebo (a pill with no study drug) for 6 weeks, in an order chosen by chance.
TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manage their diabetes. Participants using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment. The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks. There will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participants will cross-over to the treatment that they did not receive in the first treatment period.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Fasting C-peptide below 0.6 ng/ml. This blood test shows how much insulin your body makes.
- Blood sugar was in the target range less than 70% of the time, on average, during the 7 days before the first visit, based on your own continuous glucose monitor (CGM).
- Have used a hybrid closed loop insulin pump for at least 3 months and agree to keep the same pump model during the study.
- Agree to wear a study-provided CGM, a device that tracks blood sugar, during the study.
- Liver blood tests meet these limits: bilirubin no more than twice the upper normal limit, and ALT and AST no more than 3 times the upper normal limit.
Who can't join
- Have type 2 diabetes, a rare or inherited form of diabetes, or diabetes caused by another disease.
- Were hospitalized for diabetic ketoacidosis (DKA), a dangerous buildup of acids in the blood, within 3 months.
- Have an uncontrolled thyroid condition or ongoing, uncontrolled high blood pressure.
- Have a heart rhythm test result called QTcF above 450 milliseconds for males or 470 for females; or a personal or family history of long QT syndrome or other listed serious heart rhythm problems.
- Have significant heart or blood vessel disease, including disease affecting blood flow to the brain.
- Have advanced diabetes-related eye damage or damage to the center of the retina that needs prompt treatment.
- Have a serious illness affecting the body, such as HIV or active hepatitis B or C; or were diagnosed with or treated for cancer within 3 years.
- Within 30 days, used diabetes medicines other than insulin, antipsychotic medicines, or steroid medicines that affect the whole body for at least 7 days for a temporary condition.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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,
Study sites (1)
GA
- Atlanta Diabetes Associates · Atlanta, GA 30318Bruce W Bode, MD · Principal investigatorMore trials in Atlanta