A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

NCT ID: NCT03981627

Last Updated: 2020-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2020-06-27

Brief Summary

This is a randomized, double-blind, active-controlled, 2 period cross-over clinical trial in subjects with type 1 diabetes mellitus using a Multiple Daily Injection (MDI) regimen.

Detailed Description

After a screening visit, eligible subjects will enter a run-in period. Subjects will receive a Continuous Glucose Monitoring (CGM) system for glucose monitoring and control at the beginning of the run-in and for the whole duration of the study. Each eligible subject will then be randomly allocated to a sequence of the 2 treatments, i.e. multiple daily injections of ADO09 and insulin aspart during 2 dosing periods. At Day 1 a mixed meal test (MMT) will be conducted at breakfast and subjects will remain at the clinical site until day 3. At Day 3 subjects will leave the clinical site and continue the treatment with IMP for the next 3 weeks. On Day 23 subjects will come back for a MMT on Day 24.

This study is constituted of 2 parts. In the first part (Part A), only subjects with daily prandial insulin dose ≤ 40 U/day will be enrolled.

Following the completion of the part A, an extension part (Part B) will be conducted to particularly assess the safety and tolerability of higher daily doses of ADO09 in patients with insulin requirements ≥ 40 U/day.

The clinical conduct and procedures will not change for the Extension Part of the study.

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

Group Type: EXPERIMENTAL

ADO09 formulation

Intervention Type: DRUG

Subcutaneous injection of ADO09 formulation

NovoRapid®

Subcutaneous injection of insulin aspart

Group Type: ACTIVE_COMPARATOR

NovoRapid®

Intervention Type: DRUG

Subcutaneous injection of insulin aspart

Interventions

ADO09 formulation

Subcutaneous injection of ADO09 formulation

Intervention Type: DRUG

NovoRapid®

Subcutaneous injection of insulin aspart

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed and dated informed consent obtained before any trial-related activities.
• Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months.
• Treated with insulin ≥ 12 months.
• Using a multiple dosing insulin therapy (MDI) with basal and bolus insulin.
• HbA1c ≤ 9.0%.
• Fasting negative C-peptide (≤ 0.30 nmol/L).
• Total daily prandial dose: ≤ 40U in the Part A and ≥ 40 U in the Part B

Exclusion Criteria

• Known or suspected hypersensitivity to products used in the clinical trial
• Type 2 diabetes mellitus
• Previous participation in this trial. Participation is defined as randomized.
• Receipt of any medicinal product in clinical development within 3 months before randomization in this trial.
• 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.
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
• 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

References

Andersen G, Eloy R, Famulla S, Heise T, Meiffren G, Seroussi C, Gaudier M, Megret C, Chan YP, Soula O, Riddle M. A co-formulation of pramlintide and insulin A21G (ADO09) improves postprandial glucose and short-term control of mean glucose, time in range, and body weight versus insulin aspart in adults with type 1 diabetes. Diabetes Obes Metab. 2023 May;25(5):1241-1248. doi: 10.1111/dom.14972. Epub 2023 Jan 31.

Reference Type: DERIVED

PMID: 36633505 (View on PubMed)

Other Identifiers

CT038-ADO09

Identifier Type: -

Identifier Source: org_study_id