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

NCT02514954 | Completed Phase 1

• 1 other identifier: BC3-CT019
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Delta AUCBG,0-2h

  Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal

  2 hours

Secondary Outcomes (9)

• Delta AUCBG,0-6h

  6 hours

• BGmax

  6 hours

• tBGmax

  6 hours

• AUCLisp,0-6h,

  6 hours

• AUCGlarg,0-6h

  6 hours

Study Arms (2)

BioChaperone® Combo

EXPERIMENTAL

1 single dose 400 U/mL

Drug: Biochaperone® Combo

Humalog® Mix25

ACTIVE COMPARATOR

1 single dose 100 U/mL

Drug: Humalog® Mix25

Interventions

Biochaperone® Combo DRUG

Subcutaneous injection of an individualized dose

BioChaperone® Combo

Humalog® Mix25 DRUG

Subcutaneous injection of an individualized dose

Humalog® Mix25

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adocia: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ulrike Hövelmann, MD

  Profil Institut Für Stoffwechselfforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 4, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-11

Locations

DE (1)