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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01421147 | A Study in Adults With Type 1 Diabetes | PHASE3 | COMPLETED | 536 | — | — | Aug 1, 2011 | Apr 1, 2013 | Oct 9, 2014 | 52 | United States, Belgium +7 |
| NCT01600950 | A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus | PHASE1 | COMPLETED | 20 | — | — | May 1, 2012 | Jul 1, 2012 | Oct 7, 2014 | 1 | Germany |
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently \>150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.
| Arm | Type | Description |
|---|---|---|
| LY2963016 + Insulin Lispro | EXPERIMENTAL | LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks. |
| Lantus + Insulin Lispro | ACTIVE_COMPARATOR | Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks. |
| LY2963016 | EXPERIMENTAL | A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days. |
| Lantus | ACTIVE_COMPARATOR | A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days. |
| Name | Type | Description |
|---|---|---|
| LY2963016 | DRUG | Administered subcutaneously |
| Lantus | DRUG | Administered subcutaneously |
| Insulin Lispro | DRUG | Administered subcutaneously |
Inclusion Criteria: * Have type 1 diabetes mellitus based on the disease diagnostic criteria \[World Health Organization (WHO) Classification\] * Have duration of diabetes greater than or equal to one year * Have Hemoglobin A1c (HbA1c) less than or equal to 11.0% * On basal-bolus insulin therapy fo...