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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916640
• Other study ID #: CT034-ADO09
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2019
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2019
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Type 1 Diabetes Mellitus (as diagnosed clinically) = 12 months

• Treated with multiple daily injection = 12 months

• Treated with insulin glargine U100 or U300 or insulin detemir at screening

• Fasting C-peptide = 0.30 nmol/L

• BMI: 18.5-28.0 kg/m² (both inclusive)

Exclusion Criteria:

• Known or suspected hypersensitivity to IMPs, paracetamol or related products

• Type 2 Diabetes Mellitus

• Clinically significant abnormal haematology, biochemistry or urinalysis screening test, as judged by the investigator considering the underlying disease

• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator

• Known slowing of gastric emptying, including gastroparesis and or gastrointestinal surgery that in the opinion of the investigator, might change gastrointestinal motility and food absorption

• Intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• ADO09 formulation
Subcutaneous injection of ADO09 formulation
• Placebo
Subcutaneous injection of 0.9% NaCl
• Symlin®
Subcutaneous injection of pramlintide
• Humulin®
Subcutaneous injection of human insulin
• Humalog®
Subcutaneous injection of insulin lispro

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CmaxPram	Maximum pramlintide concentration	From 0 to 8 hours
Primary	AUCPram 0-8h	Area under the pramlintide concentration-time curve from 0-8 hours after IMP administration	From 0 to 8 hours
Primary	CmaxIns	Maximum insulin analog concentration	From 0 to 8 hours
Primary	AUCIns 0-8h	Area under the insulin analog concentration-time curve from 0-8 hours after IMP administration	From 0 to 8 hours
Secondary	Pharmacokinetics of pramlintide	Area under the pramlintide concentration-time curve	From 0 to 8 hours
Secondary	Pharmacokinetics of insulins	Area under the insulins concentration-time curve	From 0 to 8 hours
Secondary	Glucose pharmacodynamics	Area under the blood glucose concentration-time curve	From 0 to 8 hours
Secondary	Safety and tolerability (Adverse Events recording)	Number of Adverse Events	From 0 to 8 hours