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

NCT ID: NCT02514954

Last Updated: 2015-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-11-30

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Study Design

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

Study Groups

BioChaperone® Combo

1 single dose 400 U/mL

Group Type: EXPERIMENTAL

Biochaperone® Combo

Intervention Type: DRUG

Subcutaneous injection of an individualized dose

Humalog® Mix25

1 single dose 100 U/mL

Group Type: ACTIVE_COMPARATOR

Humalog® Mix25

Intervention Type: DRUG

Subcutaneous injection of an individualized dose

Interventions

Biochaperone® Combo

Subcutaneous injection of an individualized dose

Intervention Type: DRUG

Humalog® Mix25

Subcutaneous injection of an individualized dose

Intervention Type: DRUG

Eligibility 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.

• 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

Ulrike Hövelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut Für Stoffwechselfforschung GmbH

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Countries

Germany

Other Identifiers

BC3-CT019

Identifier Type: -

Identifier Source: org_study_id