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

NCT ID: NCT03916640

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2019-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Co-formulation of insulin analog and pramlintide (ADO09)

Subcutaneous injection of ADO09 formulation + injection of placebo (0.9% NaCl) to ensure double dummy.

Group Type: EXPERIMENTAL

ADO09 formulation

Intervention Type: DRUG

Subcutaneous injection of ADO09 formulation

Placebo

Intervention Type: DRUG

Subcutaneous injection of 0.9% NaCl

Humulin® + Symlin®

Simultaneous, separate subcutaneous injections of human insulin and pramlintide.

Group Type: ACTIVE_COMPARATOR

Symlin®

Intervention Type: DRUG

Subcutaneous injection of pramlintide

Humulin®

Intervention Type: DRUG

Subcutaneous injection of human insulin

Humalog®

Subcutaneous injection of insulin lispro + injection of placebo (0.9% NaCl) to ensure double dummy.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous injection of 0.9% NaCl

Humalog®

Intervention Type: DRUG

Subcutaneous injection of insulin lispro

Interventions

ADO09 formulation

Subcutaneous injection of ADO09 formulation

Intervention Type: DRUG

Placebo

Subcutaneous injection of 0.9% NaCl

Intervention Type: DRUG

Symlin®

Subcutaneous injection of pramlintide

Intervention Type: DRUG

Humulin®

Subcutaneous injection of human insulin

Intervention Type: DRUG

Humalog®

Subcutaneous injection of insulin lispro

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adocia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grit Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Countries

Germany

Other Identifiers

CT034-ADO09

Identifier Type: -

Identifier Source: org_study_id