Healthy VolunteersPhase 1RHINE-4NCT05413863

Comparison of the Pharmacokinetic and Pharmacodynamic Properties of Biocon's Insulin R U-500 With Humulin® R U-500 (US Reference Product) in Healthy Subjects

A Phase 1 study testing Biocon's Human Insulin R U-500 and Humulin® R U-500 (US Reference Product) in people with Healthy Volunteers, run by Biocon Limited 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

Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Biocon's Human Insulin R U-500 and Humulin® R U-500 (US Reference Product)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteGermany
Study dates: 30 May 2022to 12 Dec 2022
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or post-menopausal female subjects. The post-menopausal state is defined as no menses for 12 months without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (≥ 25.8 IU/L).
Age between 18 and 55 years, both inclusive.
Body Mass Index (BMI) between 18.5 and 29.0 kg/m2, both inclusive.
Fasting plasma glucose concentration ≤ 100 mg/dL.
Considered generally healthy upon completing the medical history and screening safety assessments, as judged by the Investigator.

Who cannot join

Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related products.
Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation in this trial.
Systolic blood pressure < 90 mmHg or > 139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg after resting for at least 5 minutes in the supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
Pulse rate at rest outside the range of 50-90 beats per minute.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Profil Institut für Stoffwechselforschung GmbH 9
Neuss, D-41460

Other trials in Germany

About this study

Official title: A Randomised, Double-blind, Three-period, Partially Replicated Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon's Human Insulin R U-500 and Humulin® R U-500 (RHINE-4: Recombinant Human INsulin Equivalence-4)

Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects

Read the detailed description

The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon's Human Insulin R U-500 with Humulin® R U-500 in healthy subjects.

The treatment consists of one single dose of the test or reference product, administered during each of the three study periods, separated by 5-7 days between each dosing. The planned trial duration for each subject is about 18 to 44 days. Eligible subjects will undergo three euglycaemic clamp examinations (each of 24 hours duration).

Depending on the sequence in which a particular subject is randomized, each subject will either undergo two clamps with administration of test product plus one clamp with administration of reference product, or, two clamps with administration of reference product plus one clamp with administration of test product, in random order.

Conditions: Healthy Volunteers
Being tested: Biocon's Human Insulin R U-500, Humulin® R U-500 (US Reference Product)
Keywords: Recombinant Human INsulin Equivalence-4, RHINE-4, Pharmacokinetic, Pharmacodynamic, Biocon's Insulin R U-500, Humulin® R U-500

What participants receive

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

Biocon's Human Insulin R U-500Biological
Biocon's Human Insulin R U-500 (Insulin Human Injection 500 units/mL), 3 mL cartridges (containing 1,500 units of insulin).
Humulin® R U-500 (US Reference Product)Biological
Humulin® R U-500 (US Reference Product), 3 mL single-patient-use KwikPen® (containing 1,500 units of insulin)

Study groups in NCT05413863
Study group	Role	What they receive
Sequence: Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500- Humulin® R U-500	Experimental	Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Receives: Biological: Biocon's Human Insulin R U-500; Biological: Humulin® R U-500 (US Reference Product)
Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500- Humulin® R U-500	Experimental	Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Receives: Biological: Biocon's Human Insulin R U-500; Biological: Humulin® R U-500 (US Reference Product)
Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500	Experimental	Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Receives: Biological: Biocon's Human Insulin R U-500; Biological: Humulin® R U-500 (US Reference Product)
Sequence: Humulin® R U-500-Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500	Experimental	Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Receives: Biological: Biocon's Human Insulin R U-500; Biological: Humulin® R U-500 (US Reference Product)
Sequence: Humulin® R U-500 -Biocon's Human Insulin R U-500-Humulin® R U-500	Experimental	Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Receives: Biological: Biocon's Human Insulin R U-500; Biological: Humulin® R U-500 (US Reference Product)
Sequence: Humulin® R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500	Experimental	Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD(Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Receives: Biological: Biocon's Human Insulin R U-500; Biological: Humulin® R U-500 (US Reference Product)

What is being measured

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

Primary pharmacokinetics (PK) endpoint: area under the insulin concentration curve(AUCins).0-12h
Area under the insulin concentration curve
Measured: 0 to12 hours
Primary pharmacokinetics (PK) endpoint: maximum observed insulin concentration(Cins.max)
Maximum observed insulin concentration
Measured: NAP (Not Applicable)
Primary pharmacodynamics (PD) endpoint:area under the glucose infusion rate curve (AUCGIR)0-12h
Area under the glucose infusion rate curve
Measured: 0 to 12 hours
Primary pharmacodynamics (PD) endpoint:maximum observed glucose infusion rate (GIRmax)
Maximum observed glucose infusion rate
Measured: NAP (Not Applicable)

Secondary outcomes (14)

Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-infinity
Area under the insulin concentration-time curve
Measured: 0 hours to 24 hours
Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-24h
Area under the insulin concentration-time curve
Measured: 0 to 24 hours
Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve (AUCins).12-24h
Area under the insulin concentration-time curve
Measured: 12 to 24 hours
Secondary pharmacokinetics (PK) endpoint:time to maximum observed insulin concentration (tmax.ins)
Time to maximum observed insulin concentration
Measured: 0 to 24 hours
Secondary pharmacokinetics (PK) endpoint:terminal elimination rate constant of insulin (λz)
Terminal elimination rate constant of insulin
Measured: 0 to 24 hours
Secondary pharmacokinetics (PK) endpoint: terminal elimination half-life (t½)
Terminal elimination half-life calculated
Measured: 0 to 24 hours
Secondary pharmacokinetics (PK) endpoint: time(t)50%-Insulin (INS)(early)
Time to half-maximum before Cmax
Measured: 0 to 24 hours
Secondary pharmacokinetics (PK) endpoint: time(t) 50%-Insulin (INS)(late)
Time to half-maximum after Cmax
Measured: 0 to 24 hours
Secondary pharmacodynamics (PD) endpoint: areas under the glucose infusion rate curve(AUCGIR).0-24h
Area under the glucose infusion rate curve
Measured: 0 to 24 hours
Secondary pharmacodynamics (PD) endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h
Area under the glucose infusion rate curve
Measured: 12 to 24 hours
Secondary pharmacodynamics (PD) endpoint: time to maximum glucose infusion rate(tmax.GIR)
Time to maximum glucose infusion rate
Measured: 0 to 24 hours
Secondary pharmacodynamics (PD) endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early)
Time to half-maximum glucose infusion rate before GIRmax
Measured: 0 to 24 hours
Secondary pharmacodynamics (PD) endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late)
Time to half-maximum glucose infusion rate after GIRmax
Measured: 0 to 24 hours
Secondary pharmacodynamics (PD) endpoint: Onset of action, time from trial product administration until plasma glucose concentration has decreased at least 5 mg/dL from baseline,
Time from trial product administration until plasma glucose concentration
Measured: 0 to 24 hours

Timeline

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

30 May 202212 Dec 2022

First posted10 Jun 2022
Study start30 May 2022
Primary completion12 Dec 2022
Study completion12 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Partially replicated design, crossover trial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05413863
Sponsor's protocol ID: BIO-INS500-101
Acronym: RHINE-4
Status last verified: May 2023
First submitted: 7 Jun 2022
Last updated: 9 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Three-period, Partially Replicated Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon's Human Insulin R U-500 and Humulin® R U-500 (RHINE-4: Recombinant Human INsulin Equivalence-4)
ClinicalTrials.gov ID: NCT05413863
Acronym / sponsor ID: RHINE-4 / BIO-INS500-101
Conditions: Healthy Volunteers
Keywords: Recombinant Human INsulin Equivalence-4, RHINE-4, Pharmacokinetic, Pharmacodynamic, Biocon's Insulin R U-500, Humulin® R U-500
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Biocon LimitedIndustry (pharma, biotech, devices)
Collaborators: Profil Institut für Stoffwechselforschung GmbH
Study start: 30 May 2022 (actual)
Primary completion: 12 Dec 2022 (actual)
Study completion: 12 Dec 2022 (actual)
First posted: 10 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects

Detailed description

The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon's Human Insulin R U-500 with Humulin® R U-500 in healthy subjects.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6
Model description: Partially replicated design, crossover trial

Arm	Type	Receives
Sequence: Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500- Humulin® R U-500	Experimental	Biological: Biocon's Human Insulin R U-500, Biological: Humulin® R U-500 (US Reference Product)Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe
Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500- Humulin® R U-500	Experimental	Biological: Biocon's Human Insulin R U-500, Biological: Humulin® R U-500 (US Reference Product)Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe
Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500	Experimental	Biological: Biocon's Human Insulin R U-500, Biological: Humulin® R U-500 (US Reference Product)Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe
Sequence: Humulin® R U-500-Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500	Experimental	Biological: Biocon's Human Insulin R U-500, Biological: Humulin® R U-500 (US Reference Product)Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe
Sequence: Humulin® R U-500 -Biocon's Human Insulin R U-500-Humulin® R U-500	Experimental	Biological: Biocon's Human Insulin R U-500, Biological: Humulin® R U-500 (US Reference Product)Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe
Sequence: Humulin® R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500	Experimental	Biological: Biocon's Human Insulin R U-500, Biological: Humulin® R U-500 (US Reference Product)Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD(Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy male or post-menopausal female subjects. The post-menopausal state is defined as no menses for 12 months without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (≥ 25.8 IU/L).
Age between 18 and 55 years, both inclusive.
Body Mass Index (BMI) between 18.5 and 29.0 kg/m2, both inclusive.
Fasting plasma glucose concentration ≤ 100 mg/dL.
Considered generally healthy upon completing the medical history and screening safety assessments, as judged by the Investigator.

Key exclusion criteria (4 listed)

Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related products.
Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation in this trial.
Systolic blood pressure < 90 mmHg or > 139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg after resting for at least 5 minutes in the supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
Pulse rate at rest outside the range of 50-90 beats per minute.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biocon's Human Insulin R U-500Biocon's Human Insulin R U-500 (Insulin Human Injection 500 units/mL), 3 mL cartridges (containing 1,500 units of insulin).	Biological	Sequence: Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500- Humulin® R U-500, Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500- Humulin® R U-500, Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500, Sequence: Humulin® R U-500 -Biocon's Human Insulin R U-500-Humulin® R U-500, Sequence: Humulin® R U-500-Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500, Sequence: Humulin® R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500
Humulin® R U-500 (US Reference Product)Humulin® R U-500 (US Reference Product), 3 mL single-patient-use KwikPen® (containing 1,500 units of insulin)	Biological	Sequence: Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500- Humulin® R U-500, Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500- Humulin® R U-500, Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500, Sequence: Humulin® R U-500 -Biocon's Human Insulin R U-500-Humulin® R U-500, Sequence: Humulin® R U-500-Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500, Sequence: Humulin® R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500

Primary outcome

Primary pharmacokinetics (PK) endpoint: area under the insulin concentration curve(AUCins).0-12h
Time frame: 0 to12 hours
Area under the insulin concentration curve
Primary pharmacokinetics (PK) endpoint: maximum observed insulin concentration(Cins.max)
Time frame: NAP (Not Applicable)
Maximum observed insulin concentration
Primary pharmacodynamics (PD) endpoint:area under the glucose infusion rate curve (AUCGIR)0-12h
Time frame: 0 to 12 hours
Area under the glucose infusion rate curve
Primary pharmacodynamics (PD) endpoint:maximum observed glucose infusion rate (GIRmax)
Time frame: NAP (Not Applicable)
Maximum observed glucose infusion rate

14 secondary outcomes

Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-infinity
Time frame: 0 hours to 24 hours
Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-24h
Time frame: 0 to 24 hours
Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve (AUCins).12-24h
Time frame: 12 to 24 hours
Secondary pharmacokinetics (PK) endpoint:time to maximum observed insulin concentration (tmax.ins)
Time frame: 0 to 24 hours
Secondary pharmacokinetics (PK) endpoint:terminal elimination rate constant of insulin (λz)
Time frame: 0 to 24 hours
Secondary pharmacokinetics (PK) endpoint: terminal elimination half-life (t½)
Time frame: 0 to 24 hours
Secondary pharmacokinetics (PK) endpoint: time(t)50%-Insulin (INS)(early)
Time frame: 0 to 24 hours
Secondary pharmacokinetics (PK) endpoint: time(t) 50%-Insulin (INS)(late)
Time frame: 0 to 24 hours
Secondary pharmacodynamics (PD) endpoint: areas under the glucose infusion rate curve(AUCGIR).0-24h
Time frame: 0 to 24 hours
Secondary pharmacodynamics (PD) endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h
Time frame: 12 to 24 hours
Secondary pharmacodynamics (PD) endpoint: time to maximum glucose infusion rate(tmax.GIR)
Time frame: 0 to 24 hours
Secondary pharmacodynamics (PD) endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early)
Time frame: 0 to 24 hours
Secondary pharmacodynamics (PD) endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late)
Time frame: 0 to 24 hours
Secondary pharmacodynamics (PD) endpoint: Onset of action, time from trial product administration until plasma glucose concentration has decreased at least 5 mg/dL from baseline,
Time frame: 0 to 24 hours

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr Ulrike Hövelmann, MD principal investigator

Profil Institut für Stoffwechselforschung GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biocon's Human Insulin R U-500 and Humulin® R U-500 (US Reference Product) in people with Healthy Volunteers, run by Biocon Limited 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 4 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 9 May 2023. 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?

Primary pharmacokinetics (PK) endpoint: area under the insulin concentration curve(AUCins).0-12h (time frame: 0 to12 hours). The study lists 4 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 NCT05413863.

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 9 May 2023.