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

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)

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: BioChaperone Human Insulin (HinsBet®); Drug: Insulin Lispro (Humalog®); Drug: Regular human insulin (Huminsulin® Normal)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 44116
    • Profil Mainz GmbH & Co.KG
  • Neuss, Germany, 41460
    • Profil GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HinsBet®	Drug: BioChaperone Human Insulin (HinsBet®); BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake
Active Comparator: Humalog®	Drug: Insulin Lispro (Humalog®); Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake
Active Comparator: Huminsulin® Normal	Drug: Regular human insulin (Huminsulin® Normal); Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BG1h	Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ΔBG1h	Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal	1 hour
AUCBG,0-1h	Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal	1 hour
ΔAUCBG,0-1h	Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal	1 hour
AUCIns,0-1h	Area under the serum insulin concentration-time curve from 0-1 hour	1 hour
Adverse Events	Number of Adverse Events	Up to 11 weeks
Local tolerability (Number of injection site reactions)	Number of injection site reactions	Up to 11 weeks

Collaborators and Investigators

• Sponsor: Adocia
• Investigators: Principal Investigator: Oliver Klein, MD, Profil GmbH

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Estimate): August 18, 2016
• Last Update Submitted That Met QC Criteria: August 17, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Lispro
• Other Study ID Numbers: BC3-CT021