A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM

Type 1 Diabetes Mellitus Clinical Trial

Official title:

A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739906
• Other study ID #: BC3-CT021
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 12, 2016
• Last updated: August 17, 2016
• Start date: April 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• 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

This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.

Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.

Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.

The total trial duration for an individual subject will be up to 11 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female subject aged 18-64 years (both inclusive).

• 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.

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

• HbA1c <= 9.0 % by local laboratory analysis

• Fasting C-peptide <= 0.30 nmol/L.

Exclusion Criteria:

• Known or suspected hypersensitivity to IMPs 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, coagulation, 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.

• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy 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 Human Insulin (HinsBet®)
BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake
• Insulin Lispro (Humalog®)
Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake
• Regular human insulin (Huminsulin® Normal)
Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake

Locations

Country	Name	City	State
Germany	Profil Mainz GmbH & Co.KG	Mainz
Germany	Profil GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BG1h	Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal	1 hour	No
Secondary	?BG1h	Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal	1 hour	No
Secondary	AUCBG,0-1h	Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal	1 hour	No
Secondary	?AUCBG,0-1h	Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal	1 hour	No
Secondary	AUCIns,0-1h	Area under the serum insulin concentration-time curve from 0-1 hour	1 hour	No
Secondary	Adverse Events	Number of Adverse Events	Up to 11 weeks	Yes
Secondary	Local tolerability (Number of injection site reactions)	Number of injection site reactions	Up to 11 weeks	Yes