This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Huminsulin® Profil III. All participants will receive both study treatments on two separate dosing days.
Daily injections of insulin is a necessity for many patients with diabetes mellitus in order to treat hyperglycaemia. Julphar Insulin 30/70 and Humininsulin® Profil III are both biphasic insulins, i.e. consist of a mixture of short-acting soluble insulin and intermediate-acting isophane insulin. The new insulin, Julphar Insulin 30/70, is biosimilar to Huminsulin® Profil III. Demonstration of similar absorption (PK) and effects (PD) are necessary to achieve market approval of Julphar Insulin 30/70.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
73
investigational insulin, biosimilar human insulin suspension of 30% normal insulin and 70% basal protamined insulin
marketed product, human insulin suspension of 30% normal insulin and 70% basal (NPH) insulin
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
PK: AUCins.0-24, harea under the serum insulin concentration curve from 0-24 hours
Time frame: 24 hours
PK: Cins.max, maximum observed insulin concentration
24 hours
Time frame: 24 hours
PK: AUCins.0-6h, AUCins.0-12, areas under the serum insulin concentration curve in the indicated time intervals
Time frame: 12 hours
PK: AUCins.0-∞, area under the serum insulin concentration-time curve from 0 hours to infinity
Time frame: 24 hours
PK: tmax, time to maximum observed serum insulin concentration
Time frame: 24 hours
PK: t½, terminal serum elimination half-life calculated as t½=ln2/λz
Time frame: 24 hours
PK: λz, terminal elimination rate constant of insulin
Time frame: 24 hours
PD: AUCGIR.0h-last, area under the glucose infusion rate curve from 0 hours until the end of clamp
Time frame: 24 hours
PD: GIRmax, maximum observed glucose infusion rate
Time frame: 24 hours
PD: AUCGIR.0-6h, AUCGIR.0-12h, areas under the glucose infusion rate curve in the indicated time-intervals
Time frame: 12 hours
PD: tGIR.max, time to maximum glucose infusion rate
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Time frame: 24 hours
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
Time frame: 24 hours
Adverse events
Through study completion, approx.up to approx. 39 days for each subject and up to 6 month for total study duration..
Time frame: from the first trial drug administration until the final examination
Local tolerability findings
at the injection site. Through study completion, 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.
Time frame: dosing period, approx.up to 39 days for each subject
Laboratory safety parameters
Including haematology, biochemistry and coagulation including serology (only at screening) parameters. Through study completion,
Time frame: from screening until final examination, approx.up to 60 days for each subject
Physical examination findings
Through study completion,
Time frame: from screening until final examination, approx.up to 60 days for each subject
Changes in vital signs
Through study completion,
Time frame: from screening until final examination, approx.up to 39 days for each subject
Changes in Electrocardiogram recordings
Through study completion,
Time frame: from screening until final examination, approx.up to 60 days for each subject