Health TrialsbyHealthPanel

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

ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorvTv Therapeutics

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 assistance) in the last 2 months prior to Screening

HbA1c value of <9.5% at Screening

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QDExperimental treatment 1 intervention
Group B: Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BIDExperimental treatment 1 intervention
Group C: Placebo: 26 Week Double Blind Treatment PeriodPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in incidence of Level 2 or Level 3 hypoglycemia

Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo.

Time frame
26 weeks

Secondary outcomes

1

To assess the change in HbA1c

Change from baseline in HbA1c in participants on cadisegliatin vs placebo.

Time frame
26 weeks
2

To assess the effects of treatment on CGM-based metrics for glycemic control

Change from baseline for time in, above or below target range of participants on cadisegliatin vs placebo

Time frame
26 weeks
3

To assess the effects of treatment on the incidence of diabetic ketoacidosis

Number of events of diabetic ketoacidosis participants on cadisegliatin vs placebo

Time frame
26 weeks
4

To assess the effects of treatment on insulin dosing

Change from baseline in average daily total insulin on cadisegliatin vs placebo

Time frame
18 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

vTv Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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