Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
vTv Therapeutics
Study ID
NCT07616206
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes (T1D)

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
  • Placebo — DRUG
    Placebo (insulin alone)

Study Details

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 manager their diabetes. Patients 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 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the treatment arm that they did not receive in the first treatment period.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Cadisegliatin 800 mg QD: Double Blind, Randomized Crossover Trial Design
    If a patient is randomized to receive cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the placebo QD along with their insulin treatment arm
  • Placebo Comparator: Placebo: Double Blind, Randomized Crossover Trial Design
    If a patient is randomized to receive placebo QD along with their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment arm

Primary Outcome Measure

To assess the change in Time in Range (TIR) [ Time Frame: last 2 weeks of the two 6-week treatment periods ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta Diabetes AssociatesAtlantaGeorgia30318
Bruce W Bode, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Atlanta Diabetes Associates· Atlanta, GA

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