Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin N and Huminsulin® Basal

NCT02634528 | Completed Phase 1

• 2 other identifiers: INSULCT-0032016-003628-21
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human isophane Insulin, Julphar Insulin N, and the already approved reference Insulin, Huminsulin® Basal. All participants will receive both study treatments on two separate dosing days.

Conditions

Diabetes Mellitus

Keywords

intermediate-acting human isophane insulin, biosimilar

Outcome Measures

Primary Outcomes (2)

• PK: AUCins.0-24h, area under the serum insulin concentration curve from 0 to 24 hours

  Primary endpoints according EMA guidelines

  24 hours

• PK: Cins.max, maximum observed insulin concentration

  Primary endpoints according EMA guidelines

  24 hours

Secondary Outcomes (16)

• PK: AUCins.0-6h, AUCins.0-12, areas under the serum insulin concentration curve in the indicated time intervals

  12 hours

• PK: AUCins.0-∞, area under the serum insulin concentration-time curve from 0 hours to infinity

  24 hours

• PK: tmax, time to maximum observed serum insulin concentration

  24 hours

• PK: t½, terminal serum elimination half-life calculated as t½=ln2/λz

  24 hours

• PK: λz, terminal elimination rate constant of insulin

  24 hours

Study Arms (2)

Julphar Insulin N

EXPERIMENTAL

Julphar Insulin N, human isophane insulin, 100 IU/mL, single subcutaneous injection of 0.6 IU/kg body weight

Drug: Julphar Insulin N (human isophane insulin)

Huminsulin® Basal

ACTIVE COMPARATOR

Huminsulin® Basal, neutral protamine hagedorn (NPH), human isophane insulin, 100 IU/mL, single subcutaneous injection of 0.6 IU/kg body weight

Drug: Huminsulin® Basal (NPH, human isophane insulin)

Interventions

Julphar Insulin N (human isophane insulin) DRUG

investigational insulin: Julphar N (human isophane insulin), biosimilar

Also known as: Julphar Insulin N

Julphar Insulin N

Huminsulin® Basal (NPH, human isophane insulin) DRUG

marketed reference product: Huminsulin® Basal (NPH, human isophane insulin)

Also known as: Huminsulin® Basal

Huminsulin® Basal

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject).
• Healthy male subject.
• Age between 18 and 55 years, both inclusive.
• Body Mass Index (BMI) between 18.5 and 28.0 kg/m\^2, both inclusive.
• Fasting plasma glucose concentration ≤100 mg/dL.

You may not qualify if:

• Known or suspected hypersensitivity to IMPs or related products.
• Previous participation in this trial. Participation is defined as randomised.
• Receipt of any medicinal product in clinical development within 3 months before screening.
• Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator.
• Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness as judged by the Investigator.
• Surgery within 12 weeks before the start of the study or blood donation of more than 500 mL (or considerable blood loss) or plasma donation within the last 3 months.
• Increased risk of thrombosis, e.g., subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator.
• Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator.
• Supine blood pressure (BP) at screening (after resting for 5 minutes in a supine position) outside the range of 90 to 140 mmHg for systolic BP or 50 to 90 mmHg for diastolic BP (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial) and/or resting supine pulse \< 50 beats per minute.
• Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
• Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.
• Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
• Any medication (prescription and non-prescription drugs) within 14 days before first trial drug administration and/or anticoagulant therapy, with the exception of stable treatment with thyroid hormones, paracetamol and ibuprofen for occasional use to treat pain.

Sponsors & Collaborators

• Julphar Gulf Pharmaceutical Industries: lead
• Profil Institut für Stoffwechselforschung GmbH: collaborator

Study Sites (1)

Profil Neuss GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Isophane Insulin, Human

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Isophane; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Regular, Human; Insulin; Proinsulin; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tim Heise, MD

  Profil Neuss, GmbH

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 18, 2015
• Study Start: November 16, 2016
• Primary Completion: January 20, 2017
• Study Completion: January 20, 2017
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)