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

Conditions

• Diabetes Mellitus, Type 1

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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)

Study Details

This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.

Key Dates

Start date

Jun 14, 2024

Status verified

May 2026

Primary completion

Sep 30, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD
  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.
• Experimental: Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BID
  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 Comparator: Placebo: 26 Week Double Blind Treatment Period
  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.

Primary Outcome Measure

Change in incidence of Level 2 or Level 3 hypoglycemia [ Time Frame: 26 weeks ]

Central Contacts

• Jennifer Freeman, Ph.D.
  (336) 888-0435
  [email protected]

Locations (60)

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