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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003993-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Profil Institut für Stoffwechselforschung GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Julphar Insulin 30/70 | Experimental | human biphasic insulin, 100 IU/mL, single subcutaneous injection of 0.6 IU/ kg body weight |
|
| Huminsulin® Profil III | Active Comparator | human biphasic insulin, reference, 100 IU/mL, single subcutaneous injection of 0.6 IU/ kg body weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human biphasic insulin | Drug | investigational insulin, biosimilar human insulin suspension of 30% normal insulin and 70% basal protamined insulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK: AUCins.0-24, harea under the serum insulin concentration curve from 0-24 hours | 24 hours | |
| PK: Cins.max, maximum observed insulin concentration | 24 hours | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Hövelmann, MD | Profil Institut für Stoffwechselforschung GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | 41460 | Germany |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C575870 | biphasic human insulin 30 |
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|
| human biphasic insulin, reference | Drug | marketed product, human insulin suspension of 30% normal insulin and 70% basal (NPH) insulin |
|
|
| 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 |
| PD: AUCGIR.0h-last, area under the glucose infusion rate curve from 0 hours until the end of clamp | 24 hours |
| PD: GIRmax, maximum observed glucose infusion rate | 24 hours |
| PD: AUCGIR.0-6h, AUCGIR.0-12h, areas under the glucose infusion rate curve in the indicated time-intervals | 12 hours |
| PD: tGIR.max, time to maximum glucose infusion rate | 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 | 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.. | 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:
| 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, | from screening until final examination, approx.up to 60 days for each subject |
| Physical examination findings | Through study completion, | from screening until final examination, approx.up to 60 days for each subject |
| Changes in vital signs | Through study completion, | from screening until final examination, approx.up to 39 days for each subject |
| Changes in Electrocardiogram recordings | Through study completion, | from screening until final examination, approx.up to 60 days for each subject |