A study to evaluate the PK and PD of oral IN-105 (Insulin Tregopil) w.r.t. time of dosing prior to meal, duration between meals and type of meal .
A Phase 1, Randomized, Placebo Controlled, Crossover Trial in Type 2 Diabetes Patients to evaluate the effect of pre-meal dosing time, inter-meal interval and meal composition on the PK and PD of IN-105 (Insulin Tregopil), an oral insulin; conducted in 3 sequential cohorts in an adaptive manner .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
15 mg strength tablets for oral use used at a dose of 30 mg
Placebo tablet for oral use
Area under the plasma concentration-time curve (AUC0-last) will be assessed (Cohort 1)
Area under the plasma concentration-time curve (AUC0-last; from dosing time to 180 minutes post meal, extrapolated) after single dose administration in the 30 ,20 and 10 minute pre-meal dosing groups
Time frame: from dosing time to 180 minutes post meal, extrapolated
The maximum observed plasma drug concentration (Cmax) will be assessed (Cohort 1)
The maximum observed plasma drug concentration after single dose administration (Cmax)
Time frame: from dosing time to 180 minutes post meal
Glucose AUC0-t will be assessed (Cohort 1)
Glucose AUC0-t \[AUC both above and below the baseline values\]
Time frame: from dosing time to 180 minutes post meal
Glucose concentration (Cmin) will be assessed (Cohort 1)
Minimum observed glucose concentration (Cmin)
Time frame: from dosing time to 180 minutes post meal
Glucose concentration (Tmin) will be assessed (Cohort 1)
Time of minimum observed glucose concentration (Tmin)
Time frame: from dosing time to 180 minutes post meal
Area under the plasma concentration-time curve (AUC0-last) will be assessed (Cohort 2)
Area under the plasma concentration-time curve (AUC0-last; time of dosing to 180 minutes post dose, extrapolated) after single dose administration in morning and afternoon in the 4, 5 and 6 h inter-meal interval groups.
Time frame: time of dosing to 180 minutes post dose,extrapolated
The maximum observed plasma drug concentration (Cmax) will be assessed. (Cohort 2)
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The maximum observed plasma drug concentration after single dose administration (Cmax)
Time frame: time of dosing to 180 minutes post dose
Glucose AUC0-t will be assessed (Cohort 2)
Glucose AUC0-t \[AUC both above and below the baseline values\]
Time frame: time of dosing to 180 minutes post dose
Glucose concentration (Cmin) will be assessed (Cohort 2)
Minimum observed glucose concentration (Cmin)
Time frame: time of dosing to 180 minutes post dose
Glucose concentration (Tmin) will be assessed (Cohort 2)
Time of minimum observed glucose concentration (Tmin)
Time frame: time of dosing to 180 minutes post dose
Area under the plasma concentration-time curve (AUC0-last) will be assessed (Cohort 3)
Area under the plasma concentration-time curve (AUC0-last) for high-fat, high-fibre and ADA meal groups after single dose administration in morning and afternoon
Time frame: time of dosing to 180 minutes post dose,extrapolated
The maximum observed plasma drug concentration (Cmax) will be assessed (Cohort 3)
The maximum observed plasma drug concentration after single dose administration (Cmax)
Time frame: time of dosing to 180 minutes post dose
Glucose AUC0-t will be assessed (Cohort 3)
Glucose AUC0-t \[AUC both above and below the baseline values\]
Time frame: time of dosing to 180 minutes post dose
Glucose concentration (Cmin) will be assessed. (Cohort 3)
Minimum observed glucose concentration (Cmin)
Time frame: time of dosing to 180 minutes post dose
Glucose concentration (Tmin) will be assessed. (Cohort 3)
Time of minimum observed glucose concentration (Tmin)
Time frame: time of dosing to 180 minutes post dose
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event including hypoglycemia that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Through study completion, approximately 3 months.