Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-FW-ITCC | Other Identifier | Eli Lilly and Company | |
| 2015-003353-18 | EudraCT Number |
Not provided
Not provided
Not provided
Change in clinical strategy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A:Insulin Lispro Test | Experimental | Individualized doses of insulin lispro test formulation administered by injection under the skin once in each of 3 periods |
|
| Part A:Insulin Lispro Reference | Active Comparator | Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods |
|
| Part B:Insulin Lispro Test | Experimental | Individualized doses of insulin lispro test formulation administered by injection under the skin with each meal for 14 days |
|
| Part B:Insulin Lispro Reference | Active Comparator | Individualized doses of insulin lispro reference formulation administered by injection under the skin with each meal for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Lispro | Drug | Administered subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| (Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro | (Part A) PK: AUC of Insulin Lispro | Time 0 to 5 hours post dose for each treatment on Day 1 |
| (Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal | (Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal | Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| (Part A) Pharmacodynamics (PD): AUC of Glucose Following a Meal | (Part A) PD: AUC of Glucose Following a Meal | Time 0 to 5 hours post meal for each treatment on Day 1 |
| (Part B) PD: AUC of Glucose Following a Meal |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
(Part B) PD: AUC of Glucose Following a Meal
| Time 0 to 5 hours post meal on Day1 and Day14 of study treatment |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |