Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01792284 | A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus | PHASE3 | COMPLETED | 212 | — | — | Feb 1, 2013 | Apr 1, 2014 | Apr 20, 2018 | 18 | United States, Puerto Rico |
| NCT01925989 | A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics | PHASE1 | COMPLETED | 27 | — | — | Nov 1, 2013 | Oct 1, 2015 | Mar 1, 2019 | 1 | United States |
HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Lipid or glucose metabolism was assessed by the measurement of respiratory quotient (RQ) during sleep using whole room calorimetry. RQ is a calculation of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry (WRC).
| Arm | Type | Description |
|---|---|---|
| LY2605541 Fixed Time Dosing | EXPERIMENTAL | Participant-specific dose of LY2605541 administered subcutaneously (SQ) at approximately the same time every evening for 12 weeks in the Lead-in Period and in Randomization Period 1 or Randomization Period 2. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal). Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on self-monitored blood glucose (SMBG). Target glucose values were as follows: Preprandial and bedtime BG between 71 and 130 milligrams/deciliter (mg/dL) Insulin adjustment and glucose correction between 71 and 100 mg/dL. |
| LY2605541 Variable Time Dosing | EXPERIMENTAL | Participant-specific dose of LY2605541 administered SQ on a variable time schedule (8- and 40-hour dosing intervals) for 12 weeks in Randomization Period 1 or Randomization Period 2. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal). Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows: Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL. |
| Insulin Peglispro/Insulin Glargine | EXPERIMENTAL | Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. |
| Insulin Glargine/Insulin Peglispro | ACTIVE_COMPARATOR | Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. |
| Control | NO_INTERVENTION | Control Arm. Untreated healthy participants. |
| Name | Type | Description |
|---|---|---|
| LY2605541 | DRUG | - |
| Insulin Lispro | DRUG | All participants will be administering insulin lispro SQ as their pre-meal insulin during the course of the trial. |
| Insulin Glargine | BIOLOGICAL | Administered SQ |
Inclusion Criteria: * Type 1 diabetes mellitus for at least 1 year * Have an HbA1c value \<9.0% * Have a body mass index (BMI) ≤35.0 kilogram per square meter (kg/m\^2) * Currently using basal/ bolus insulin * Women of childbearing potential are not breastfeeding and must use methods to prevent pre...