Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits. At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal [(t=0 min) start of the meal]. Insulin doses will be identical at both dosing visits of one individual and will be administered subcutaneously in the abdominal region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home in the evening before each dosing visit. Subjects will attend the clinical site in a fasted state in the morning of each dosing day and stay at the clinical trial centre until 10-hour after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing visits will be separated by a wash-out period of 5-15 days.

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

Details

• Lead Sponsor: Adocia
• Treatments: Insulin Lispro

Criteria

Inclusion Criteria:

• Type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.

• Treated with multiple daily insulin injections or CSII >= 12 months.

• Current total daily insulin treatment < 1.2 (I)U/kg/day.

• Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.

• Usual Insulin bolus dose between 0.8 and 2 (I)U per 10 g CH (both inclusive). Expecting prandial insulin dose range for standardised meal test between 5 and 12 (I)U.

• BMI 18.5-28.0 kg/m^2 (both inclusive).

• HbA1c <= 9.0% by local laboratory analysis

• Fasting C-peptide <= 0.3 nmol/L.

Exclusion Criteria:

• Known or suspected hypersensitivity to trial products or related products.

• Type 2 diabetes mellitus.

• Previous participation in this trial. Participation is defined as randomised.

• Participation in any Clinical Trial within 3 months prior to this trial.

• Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, 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 and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.

• Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.

• Women of child bearing potential, not willing to use contraceptive methods.