NCT03392961

Effect of Dosing Time and Meal on IN-105 (Insulin Tregopil) PK and PD

To Assess the Pharmacokinetics and Pharmacodynamics of IN-105 in Relation to the Pre-meal Dosing Time, Between-meal Interval and Type of Meal - A Phase 1, Three Cohort, Randomized, Placebo Controlled, Crossover Trial in Type 2 Diabetes Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Biocon Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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 .

Detailed description

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 .

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	IN-105 (Insulin Tregopil)	15 mg strength tablets for oral use used at a dose of 30 mg
OTHER	Placebo comparator	Placebo tablet for oral use

Timeline

• Start date: 2014-03-27
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2018-01-08
• Last updated: 2018-01-23

Regulatory

• FDA-regulated drug study