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| ID | Type | Description | Link |
|---|---|---|---|
| J2H-MC-IUAA | Other Identifier | Eli Lilly and Company | |
| 2019-002318-37 | EudraCT Number |
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The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900027 | Experimental | LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods. |
|
| Insulin Lispro | Active Comparator | Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900027 | Drug | LY900027 administered to participants with T1DM using CSII. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT) | PK: AUC after Bolus Administration Prior to a MMTT | Day 1 through Day 10 in each dosing period |
| PK: Maximum Observed Insulin Lispro Concentration (Cmax) | PK: C PK: Cmax | Day 1 through Day 10 in each dosing period |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion | PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion | Day 1 through Day 10 in each dosing period |
| PD: Total Daily Insulin Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung | Neuss | North Rhine-Westphalia | 41460 | Germany |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Lispro |
| Drug |
Insulin lispro administered to participants with T1DM using CSII. |
|
|
PD: Total Daily Insulin Dose |
| Day 1 through Day 10 in each dosing period |
| Duration Until Catheter Failure | Duration Until Catheter Failure | Day -1 through Day 10 in each dosing period |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |