NCT03916640

A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus

A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.

Detailed description

In this monocentric, randomised, double-blind, active comparator, controlled, cross-over trial, each patient will be randomly allocated to a sequence of three treatments: one single dose of the co-formulation of insulin analog and pramlintide (also called ADO09), simultaneous separate injections of pramlintide and human insulin and one single dose of insulin lispro. To keep the blinding in this trial, a placebo injection will be given in addition to the ADO09 formulation and insulin lispro dose for a total of 2 injections per dosing visit. During each visit, meal test procedures will be performed and subjects will stay at the clinical centre until post-dose follow-up period has been terminated. IMP administration will be done subcutaneously immediately prior to test meal intake.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ADO09 formulation	Subcutaneous injection of ADO09 formulation
DRUG	Placebo	Subcutaneous injection of 0.9% NaCl
DRUG	Symlin®	Subcutaneous injection of pramlintide
DRUG	Humulin®	Subcutaneous injection of human insulin
DRUG	Humalog®	Subcutaneous injection of insulin lispro

Timeline

• Start date: 2019-01-04
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2019-04-16
• Last updated: 2019-04-16

Locations

1 site across 1 country: Germany