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

NCT02739906 | Completed Phase 1

• 1 other identifier: BC3-CT021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• BG1h

  Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal

  1 hour

Secondary Outcomes (6)

• ΔBG1h

  1 hour

• AUCBG,0-1h

  1 hour

• ΔAUCBG,0-1h

  1 hour

• AUCIns,0-1h

  1 hour

• Adverse Events

  Up to 11 weeks

Study Arms (3)

HinsBet®

EXPERIMENTAL

Drug: BioChaperone Human Insulin (HinsBet®)

Humalog®

ACTIVE COMPARATOR

Drug: Insulin Lispro (Humalog®)

Huminsulin® Normal

ACTIVE COMPARATOR

Drug: Regular human insulin (Huminsulin® Normal)

Interventions

BioChaperone Human Insulin (HinsBet®) DRUG

BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake

HinsBet®

Insulin Lispro (Humalog®) DRUG

Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake

Humalog®

Regular human insulin (Huminsulin® Normal) DRUG

Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake

Huminsulin® Normal

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Adocia: lead

Study Sites (2)

Profil Mainz GmbH & Co.KG

Mainz, 44116, Germany

Location

Profil GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Oliver Klein, MD

  Profil 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: April 12, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 18, 2016

Record last verified: 2016-08

Locations

DE (2)