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

• Status: Completed
• Trial end date: 2020-06-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adocia
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

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.