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New treatment option for Diabetes Mellitus, Type 1
Official title Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
ClinicalTrials.gov ID: NCT06334133
What this study is testing
What is Cadisegliatin 800 mg QD?
Cadisegliatin 800 mg QD is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for diabetes mellitus, type 1.
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
- This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.
- Phase 3: a large, late-stage study
- Time commitment: about 26 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- 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...
- 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...
You likely can't join if
- Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a...
- 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...
- Has used any of the following medications within the specified time periods - any non-insulin anti-diabetic therapies, e.g., sodium glucose...
See the full eligibility 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...
- 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...
- Must have been on a CGM device for at least 3 months prior to Screening
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Little Rock, Arkansas, United States
- Escondido, California, United States
- Fountain Valley, California, United States
- Huntington Beach, California, United States
- Inglewood, California, United States
- La Jolla, California, United States
- La Palma, California, United States
- Modesto, California, United States
- Northridge, California, United States
- San Bernardino, California, United States
- San Diego, California, United States
- Torrance, California, United States
- West Hills, California, United States
- Englewood, Colorado, United States
- Clearwater, Florida, United States
- Cooper City, Florida, United States
- Miami Gardens, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
+ 36 more site(s).
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 - confirm specifics with the study team.
How long does this study last?
The study runs about 26 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?
Study sites include Scottsdale, Arizona, United States; Little Rock, Arkansas, United States; Escondido, California, United States; Fountain Valley, California, United States; Huntington Beach, California, United States; Inglewood, California, United States and 50 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.