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

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Adocia
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc; Islet Amyloid Polypeptide; Pramlintide

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