Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Insulin lispro (Humalog), Insulin Lispro (Humalog), Lispro, Insulin Lispro (U100), Lispro SC, Lispro Prandial Insulin
Insulin Lispro · 5 trials · 4 indications
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (\>8% or ≤8%) and participants.
Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration.
| Arm | Type | Description |
|---|---|---|
| Insulin Lispro, then Insulin Aspart | ACTIVE_COMPARATOR | Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2. |
| Insulin Aspart, then Insulin Lispro | ACTIVE_COMPARATOR | Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2. |
| AID System Containing Insulin Lispro | EXPERIMENTAL | The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component. |
| Part A: Lispro (A) | EXPERIMENTAL | Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods. |
| Part A: Lispro (B) | EXPERIMENTAL | Formulation B: Single dose of lispro administered SC in one of five periods. |
| Part A: Lispro (C) | EXPERIMENTAL | Formulation C: Single dose of lispro administered SC in one of five periods. |
| Part A: Lispro (D) | EXPERIMENTAL | Formulation D: Single dose of lispro administered SC in one of five periods. |
| Part A: Lispro (Reference) | EXPERIMENTAL | Reference formulation: Single dose of lispro administered SC in one of five periods. |
| Part B: Lispro | EXPERIMENTAL | Formulation selected from Part A. Single dose of lispro administered SC in one of four periods. |
| Insulin Lispro A | ACTIVE_COMPARATOR | Insulin Lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200)administered subcutaneously (SC) once in two of four study periods.(Two doses of test \[T\]). |
| Insulin Lispro B | EXPERIMENTAL | Insulin Lispro B 20 units (U) of strength 100 U/mL (U-100) administered SC once in two of four study periods.(Two doses of reference \[R\]). |
| Insulin Lispro | ACTIVE_COMPARATOR | 15 international units (IU) insulin lispro administered once subcutaneously (SC) during 1 of 3 dosing periods. There is a minimum 7 day washout between dosing periods. |
| BC106 Insulin Lispro | EXPERIMENTAL | 15 up to 30 IU BC106 insulin lispro administered once SC during 2 of 3 dosing periods. There is a minimum 7 day washout between dosing periods. |
| Name | Type | Description |
|---|---|---|
| Insulin Lispro | DRUG | Insulin lispro (100 U/mL) administered by CSII pump |
| Insulin Aspart | DRUG | Insulin aspart (100 U/mL) administered by CSII pump |
| AID System | DEVICE | AID system |
| Lispro | DRUG | Administered SC |
| BC106 insulin lispro | DRUG | Administered SC |
Inclusion Criteria: * Have type 2 diabetes (per World Health Organization \[WHO\] Classification of Diabetes) * Have been treated with CSII therapy using a rapid-acting analog for the previous 6 months * Have a screening A1C less than or equal to 9.0% (no lower limit for A1C) * Have a body mass ind...