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The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to its total and to its maximum serum insulin concentrations.
The purpose of this study is to test for bioequivalence based on the pharmacokinetic parameter AUC INS-GLR 0-24h and on pharmacodynamic parameter AUC GIR 0-24h between the two long-acting insulin glargine formulations, Lantus® and Wockhardt's Glaritus® in subjects with type1 diabetes as well as assessing safety and local tolerability of the two insulin preparations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glaritus arm | Experimental | Insulin glargine (Glaritus: 100 U/ml), Penfill® cartridges 3.0ml |
|
| Lantus arm | Active Comparator | Insulin glargine (Lantus: 100 U/ml), Penfill® cartridges 3.0ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glargine | Biological | dosage form: Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on Pharmacokinetic parameter:AUC INS-GLR 0-24h. | over 24hrs post dose | |
| Bioequivalence based on Pharmacodynamic parameter: AUC GIR 0-24hrs | over 24hrs post dose | |
| Pharmacokinetic Parameters: Maximum concentration (Cmax) | over 24hrs post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters | Number of AE's, SAE's, Hypoglycemic events and local tolerability | till 24 hrs post-dose |
| Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-24hrs | AUC GIR 0-12h,AUC GIR 12-24h,AUC GIR 0-24h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Elaine Watkins | Profil Institute of Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for clinical Research | Chula Vista | California | 91911 | United States |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| over 24hrs post dose |
| Pharmacokinetic parameter: Area under curve from 0-24hrs | AUC INS-GLR 0-12hrs, AUC INS-GLR 12-24hrs,AUC INS-GLR 0-24hrs | over 24hrs post dose |
| Pharmacokinetic Parameters: tmax and t1/2 | over 24hrs post dose |
| Pharmacodynamic parameter: GIR max and tGIR max | over 24hrs post dose |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |