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Diabetes MellitusPhase 1NCT02634528

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

A Phase 1 study testing Julphar Insulin N (human isophane insulin) and Huminsulin® Basal (NPH, human isophane insulin) in people with Diabetes Mellitus, run by Julphar Gulf Pharmaceutical Industries at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
Julphar Insulin N (human isophane insulin) and Huminsulin® Basal (NPH, human isophane insulin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteGermany
Study dates
16 Nov 2016to 20 Jan 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 330 mL of beer, one glass of wine of 120 mL, or 40 mL spirits).
  • A positive result in the alcohol and/or urine drug screen at the screening visit.
  • 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.
  • Subject with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of the Investigator, should not participate in the trial.
  • Potentially noncompliant or uncooperative during the trial, as judged by the Investigator.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Neuss GmbH

    Neuss, 41460

Other trials in Germany

About this study

Official title: Single-center, Randomized, Double-blind, 2-treatment, 2-period Crossover Trial in Healthy Subjects to Demonstrate PK Bioequivalence and to Compare the PD Properties of Julphar Insulin N and Huminsulin® Basal

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.

Read the detailed description

Daily injections of insulin are a necessity for many patients with diabetes mellitus in order to treat hyperglycemia. Julphar Insulin N and Huminsulin® Basal are both intermediate-acting human isophane insulins, i.e. consist of a suspension containing a crystalline precipitate of isophane human insulin (NPH) complexed with protamine sulphate and zinc. The new insulin, Julphar Insulin N, is biosimilar to Huminsulin® Basal. Demonstration of similar absorption (PK) and effects (PD) are necessary to achieve market approval of Julphar Insulin N.

Being tested
Julphar Insulin N (human isophane insulin), Huminsulin® Basal (NPH, human isophane insulin)
Keywords
intermediate-acting human isophane insulin, biosimilar
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Julphar Insulin N (human isophane insulin)Drug

    Also called Julphar Insulin N

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

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

    Also called Huminsulin® Basal

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

Study groups in NCT02634528
Study groupRoleWhat they receive
Julphar Insulin NExperimentalJulphar Insulin N, human isophane insulin, 100 IU/mL, single subcutaneous injection of 0.6 IU/kg body weight
Receives: Drug: Julphar Insulin N (human isophane insulin)
Huminsulin® BasalActive comparatorHuminsulin® Basal, neutral protamine hagedorn (NPH), human isophane insulin, 100 IU/mL, single subcutaneous injection of 0.6 IU/kg body weight
Receives: Drug: Huminsulin® Basal (NPH, human isophane insulin)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Primary endpoints according EMA guidelines

    Measured: 24 hours

  2. PK: Cins.max, maximum observed insulin concentration

    Primary endpoints according EMA guidelines

    Measured: 24 hours

Secondary outcomes (16)

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

    Measured: 12 hours

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

    Measured: 24 hours

  3. PK: tmax, time to maximum observed serum insulin concentration

    Measured: 24 hours

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

    Measured: 24 hours

  5. PK: λz, terminal elimination rate constant of insulin

    Measured: 24 hours

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

    Measured: 24 hours

  7. PD: GIRmax, maximum observed glucose infusion rate

    Measured: 24 hours

  8. PD: AUCGIR.0-6h, AUCGIR.0-12h, areas under the glucose infusion rate curve in the indicated time-intervals

    Measured: 12 hours

  9. PD: tGIR.max, time to maximum glucose infusion rate

    Measured: 24 hours

  10. PD: Onset of action, time from trial product administration until blood glucose concentration has decreased at least 5 mg/dL from baseline

    baseline is defined as the mean of blood glucose levels from -6, -4, and -2 minutes before trial product administration as measured by the glucose clamp device

    Measured: 24 hours

  11. Adverse events

    Measured: from first dosing until final examination (up to 39 days for each patient)

  12. Local tolerability findings

    at the injection site, The local tolerability at the injection site will be evaluated by means of the following assessments:

    • spontaneous pain
    • pain on palpation
    • itching
    • erythema
    • oedema
    • induration/infiltration
    • other Each of these assessments will be reported on a scale of 0 (none), 1 (mild), 2 (moderate) and 3 (severe). The evaluation and the actual time of the assessment will be recorded

    Measured: dosing period (up to 25 days for each patient)

  13. Laboratory safety parameters

    Measured: from screening to final examination (up to 61 days for each patient)

  14. Physical examination findings

    Measured: from screening to final examination (up to 61 days for each patient)

  15. Changes in vital signs

    Measured: from screening to final examination (up to 61 days for each patient)

  16. Changes in Electrocardiogram recordings

    Measured: from screening to final examination (up to 61 days for each patient)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2015 (estimated)
  2. Study start16 Nov 2016
  3. Primary completion20 Jan 2017
  4. Study completion20 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02634528
Sponsor's protocol ID
INSULCT-003
Other IDs
2016-003628-21, 2016
Status last verified
Jul 2020
First submitted
11 Dec 2015
Last updated
2 Jul 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Julphar Insulin N (human isophane insulin) and Huminsulin® Basal (NPH, human isophane insulin) in people with Diabetes Mellitus, run by Julphar Gulf Pharmaceutical Industries at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK: AUCins.0-24h, area under the serum insulin concentration curve from 0 to 24 hours (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02634528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.

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