Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06334133 | Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes | PHASE3 | RECRUITING | 150 | — | — | Jun 14, 2024 | Oct 1, 2026 | Jun 2, 2026 | 61 | United States, Puerto Rico |
Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo.
| Arm | Type | Description |
|---|---|---|
| Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD | EXPERIMENTAL | The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy. |
| Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BID | EXPERIMENTAL | The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy. |
| Placebo: 26 Week Double Blind Treatment Period | PLACEBO_COMPARATOR | The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy. |
| Name | Type | Description |
|---|---|---|
| Cadisegliatin 800 mg QD | DRUG | Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin. |
| Cadisegliatin 800 mg BID | DRUG | Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin. |
| Placebo | DRUG | Placebo (insulin alone) |
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...