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Clinical Trial Details

Trial ID: L6465
Source ID: NCT03392961
Associated Drug: In-105 (Insulin Tregopil)
Title: Effect of Dosing Time and Meal on IN-105 (Insulin Tregopil) PK and PD
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: IN-105 (Insulin Tregopil)|OTHER: Placebo comparator
Outcome Measures: Primary: 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, 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), from dosing time to 180 minutes post meal|Glucose AUC0-t will be assessed (Cohort 1), Glucose AUC0-t \[AUC both above and below the baseline values\], from dosing time to 180 minutes post meal|Glucose concentration (Cmin) will be assessed (Cohort 1), Minimum observed glucose concentration (Cmin), from dosing time to 180 minutes post meal|Glucose concentration (Tmin) will be assessed (Cohort 1), Time of minimum observed glucose concentration (Tmin), 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 of dosing to 180 minutes post dose,extrapolated|The maximum observed plasma drug concentration (Cmax) will be assessed. (Cohort 2), The maximum observed plasma drug concentration after single dose administration (Cmax), 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 of dosing to 180 minutes post dose|Glucose concentration (Cmin) will be assessed (Cohort 2), Minimum observed glucose concentration (Cmin), time of dosing to 180 minutes post dose|Glucose concentration (Tmin) will be assessed (Cohort 2), Time of minimum observed glucose concentration (Tmin), 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 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 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 of dosing to 180 minutes post dose|Glucose concentration (Cmin) will be assessed. (Cohort 3), Minimum observed glucose concentration (Cmin), time of dosing to 180 minutes post dose|Glucose concentration (Tmin) will be assessed. (Cohort 3), Time of minimum observed glucose concentration (Tmin), time of dosing to 180 minutes post dose | Secondary: 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., Through study completion, approximately 3 months.
Sponsor/Collaborators: Sponsor: Biocon Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 51
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-03-27
Completion Date: 2014-07-01
Results First Posted:
Last Update Posted: 2018-01-23
Locations:
URL: https://clinicaltrials.gov/show/NCT03392961