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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514954
• Other study ID #: BC3-CT019
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2015
• Last updated: November 5, 2015
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Biochaperone® Combo
Subcutaneous injection of an individualized dose
• Humalog® Mix25
Subcutaneous injection of an individualized dose

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta AUCBG,0-2h	Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal	2 hours	No
Secondary	Delta AUCBG,0-6h	Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal	6 hours	No
Secondary	BGmax	Maximum blood glucose concentration after a standardised meal (0-6 hours)	6 hours	No
Secondary	tBGmax	Time to maximum blood glucose concentration after a standardised meal (0-6 hours)	6 hours	No
Secondary	AUCLisp,0-6h,	Area under the plasma insulin lispro concentration-time curve from 0-6 hours	6 hours	No
Secondary	AUCGlarg,0-6h	Area under the plasma insulin glargine concentration-time curve from 0-6 hours	6 hours	No
Secondary	Cmax,Lisp	Maximum observed plasma insulin lispro concentration	6 hours	No
Secondary	Cmax,Glarg	Maximum observed plasma insulin glargine concentration	6 hours	No
Secondary	Adverse events	Number of adverse events	Up to 7 weeks	Yes
Secondary	Local tolerability	Number and intensity of injection site reactions	Up to 7 weeks	Yes