NCT04141423

Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil

An Open Label, Multiple Ascending Dose Trial in Patients With T1DM to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin Tregopil and to Evaluate the Postprandial Glucose Control With Different Meal Types in Comparison With Insulin Aspart

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Biocon Limited · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Multi-centre, open label, multiple ascending dose trial in patients with type 1 diabetes mellitus

Detailed description

This is a Phase 1, open-label, multiple dose trial with two parts in patients with type 1 diabetes mellitus (T1DM). Part 1 consists of four cohorts with multiple ascending doses of insulin Tregopil and comprises a sentinel dosing design. Part 2 consists of a randomised, 2-treatment, crossover design with mixed meal tests (MMTs) of different compositions followed by parallel design titrated treatment period. Both parts include dosing during an in-house period and during a subsequent outpatient period.

Conditions

• Type 1 Diabetes Mellitus (T1DM)

Interventions

Type	Name	Description
DRUG	Tregopil	Insulin Tregopil is recombinant human insulin modified by a single amphiphilic oligomer covalently linked via an amide bond to lysine at position 29 of the B-chain. This alters the physicochemical characteristics of the molecule, leading to enhanced stability and resistance to intestinal degradation following oral administration.

Timeline

• Start date: 2019-10-28
• Primary completion: 2021-04-23
• Completion: 2021-04-23
• First posted: 2019-10-28
• Last updated: 2022-06-27

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study