Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics of Julphar Insulin R and Huminsulin® Normal

NCT02634515 | Completed Phase 1

• 1 other identifier: INSULCT001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new short-acting human soluble insulin, Julphar Insulin R, and the already approved reference insulin, Huminsulin® Normal. The trial participants received both study treatments on two separate dosing days.

Conditions

Diabetes Mellitus

Keywords

soluble human insulin, biosimilar

Outcome Measures

Primary Outcomes (4)

• PK: AUCins.0-12h, area under the serum insulin concentration time curve from 0 to 12 hours

  primary endpoint according EMA guideline

  12 hours

• PK: Cins.max, maximum serum insulin concentration

  primary endpoint according EMA guideline

  12 hours

• PD: AUCGIR.0-last, area under the glucose infusion rate curve from 0 hours until the end of the glucose clamp

  primary endpoint according EMA guideline

  12 hours

• PD: GIRmax, maximum glucose infusion rate

  primary endpoint according EMA guideline

  12 hours

Secondary Outcomes (24)

• PK: AUCins.0-4h,area under the serum insulin concentration time curve from 0 to 4 hours

  4 hours

• PK: AUCins.0-6h,area under the serum insulin concentration time curve from 0 to 6 hours

  6 hours

• PK: AUCins.6-12h, area under the serum insulin concentration time curve from 6 to 12 hours

  12 hours

• PK: AUCins.0-infinity, area under the serum insulin concentration time curve from 0 (dosing) to infinity

  12 hours

• PK: tmax, time to maximum serum insulin concentration

  12 hours

Study Arms (2)

Julphar Insulin R

EXPERIMENTAL

Julphar Insulin R, soluble human insulin, biosimilar, 100 IU/mL, single subcutaneous injection of 0.3 IU/kg body weight

Drug: Julphar Insulin R (soluble human insulin, biosimilar)

Huminsulin® Normal

ACTIVE COMPARATOR

Huminsulin® Normal, soluble human insulin, reference, 100 IU/mL, single subcutaneous injection of 0.3 IU/kg body weight

Drug: Huminsulin® Normal (soluble human insulin, reference)

Interventions

Julphar Insulin R (soluble human insulin, biosimilar) DRUG

investigational insulin, Julphar Insulin R (soluble human insulin)

Also known as: Julphar Insulin R

Julphar Insulin R

Huminsulin® Normal (soluble human insulin, reference) DRUG

marketed product, Huminsulin® Normal (soluble human insulin

Also known as: Huminsulin® Normal

Huminsulin® Normal

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• 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 procedure that would not have been performed during normal management of the subject).
• Healthy male or female subjects.
• 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 (FPG) ≤5.6 mmol/L (100 mg/dL).

You may not qualify if:

• Known or suspected hypersensitivity to trial product(s) or related products.
• Receipt of any IMP within 3 months prior to screening.
• Any history or presence of a life threatening disease (i.e., cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, musculoskeletal, articular, psychiatric, systemic, ocular, gynaecologic (females), 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.
• Haemoglobin \< 8.0 mmol/L (male) or \< 6.4 mmol/L (female), total leukocyte count \< 3.0 x 10\^9/L, thrombocytes \< 100 x 10\^9/L, serum creatinine levels ≥ 126 µmol/L (male) or ≥ 111 µmol/L (female), alanine aminotransferase (ALT) \> 2 x the upper limit of normal (ULN), bilirubin \> 3 x ULN, alkaline phosphatase \> 2 x ULN.
• 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 ECG after 5 minutes resting in a 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.
• Subject known to be positive for Hepatitis Bs antigen (HBsAg) or Hepatitis C antibodies (or diagnosed with active hepatitis according to local practice) or test positive at screening for human immunodeficiency virus Type 1 (HIV-1) antibodies, HIV Type 2 (HIV 2) antibodies, or HIV-1 antigen according to locally used diagnostic testing.
• 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, with the exception of stable treatment with thyroid hormones, paracetamol for occasional use to treat pain, and if female, with the exception of hormonal contraception or menopausal hormone replacement therapy.
• Significant history of alcoholism or drug/chemical abuse as per Investigator's judgement or a positive result in the urine drug/alcohol screen at the screening visit or consuming more than 21 units of alcohol per week (1 unit of alcohol equals approximately 330 mL of beer, 1 glass of wine (120 mL), or 40 mL spirits).
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products 1 day before and during the inpatient period/trial.

Sponsors & Collaborators

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

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Biosimilar Pharmaceuticals

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Ulrike Hövelmann

  Profil Institut für Stoffwechselforschung 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: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

DE (1)