Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LY2963016, Insulin Glargine (U100)
Insulin Glargine · 17 trials · 8 indications
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated using mixed-effects model for repeated measures (MMRM) with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time\*Treatment (Type III sum of squares).
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated by mixed-effects model for repeated measures (MMRM) with baseline, insulin secretagogues at study entry, treatment, visit and treatment\*visit in the model.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, treatment (LY2963016, LANTUS), pooled country, basal insulin at entry (yes/no), sulfonylurea (SU) use (yes/no), visit, treatment and visit\*treatment in the model.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.
Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin glargine and Lantus.
PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC\[0-24\]) of Insulin glargine and Lantus.
The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.
Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.
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.
AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.
| Arm | Type | Description |
|---|---|---|
| LY2963016 + Insulin Lispro | EXPERIMENTAL | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
| Lantus® + Insulin Lispro | ACTIVE_COMPARATOR | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
| LY2963016 | EXPERIMENTAL | Insulin naive participants started on 10 units (U) LY2963016 given subcutaneously (SC) once a day (QD) for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the fasting blood glucose (FBG) ≤100 milligram per deciliter (mg/dL) (5.6 millimoles per litre \[mmol/L\]) while avoiding hypoglycemia. Participants were allowed to continue oral antihyperglycemic medication (OAM). |
| Lantus® | ACTIVE_COMPARATOR | Insulin naive participants started on 10 U Lantus® given SC QD for 24 weeks. Participants-driven titration was supervised by investigators through the course of the study to maintain the FBG ≤100 mg/dL (5.6 mmol/L) while avoiding hypoglycemia. Participants were allowed to continue oral OAM. |
| LY2963016 + OAMs | EXPERIMENTAL | LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) \[alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)\] administered per standard of care for 24 weeks |
| Lantus + OAMs | ACTIVE_COMPARATOR | Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 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. |
| 1.5 mg LY2189265 | EXPERIMENTAL | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| 0.75 mg LY2189265 | EXPERIMENTAL | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| Insulin Glargine | ACTIVE_COMPARATOR | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks |
| LY2189265 1.5 mg | EXPERIMENTAL | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks |
| LY2189265 0.75 mg | EXPERIMENTAL | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks |
| Glargine | ACTIVE_COMPARATOR | Glargine plus Insulin Lispro (2-3 injections) |
| ILPS | EXPERIMENTAL | Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections) |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| Insulin Glargine (Period 1) | ACTIVE_COMPARATOR | Insulin glargine administered subcutaneously (SC). |
| LY3209590 (Period 2) | EXPERIMENTAL | LY3209590 administered SC. |
| Lantus | ACTIVE_COMPARATOR | Participants received 0.5 U/Kg of Lantus subcutaneously. |
| LY2963016 U-200 Formulation (Test) | EXPERIMENTAL | LY2963016 test formulation administered as a subcutaneous (SC) injection in one of two or two of four study periods. |
| LY2963016 U-100 Formulation (Reference) | EXPERIMENTAL | LY2963016 reference formulation administered as a SC injection in one of two or two of four study periods. |
| US-approved Lantus | EXPERIMENTAL | Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study |
| 0.3 U/kg LY2963016 | EXPERIMENTAL | Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016 |
| 0.3 U/kg Lantus | EXPERIMENTAL | Single 0.3 U/kg subcutaneous dose of Lantus |
| 0.6 U/kg LY2963016 | EXPERIMENTAL | Single 0.6 U/kg subcutaneous dose of LY2963016 |
| 0.6 U/kg Lantus | EXPERIMENTAL | Single 0.6 U/kg subcutaneous dose of Lantus |
| Name | Type | Description |
|---|---|---|
| LY2963016 | DRUG | Administered SC |
| Lantus® | DRUG | Administered SC |
| Insulin Lispro | DRUG | Administered SC |
| Oral Antihyperglycemic Medication | DRUG | Administered as per standard-of-care. |
| Lantus | DRUG | Administered subcutaneously |
| OAMs | DRUG | Administered orally |
| Insulin Glargine | DRUG | - |
| LY2189265 | DRUG | - |
| Metformin | DRUG | - |
| Glimepiride | DRUG | - |
| Insulin Lispro Protamine Suspension (ILPS) | DRUG | patient glucose-level dependent, injection, once daily in the evening, 24 weeks |
| Human Insulin Inhalation Powder | DRUG | patient specific dose, inhaled, before meals,12 weeks |
| Injectable Insulin | DRUG | Patient specific dose,injected, before meals, 12 weeks |
| LY3209590 | DRUG | Administered SC |
| US Approved Lantus | DRUG | Administered subcutaneously |
Inclusion Criteria: * Have T1DM based on the disease diagnostic criteria (World Health Organization \[WHO\] Classification). * Have duration of T1DM ≥1 year. * Have HbA1c ≤11 %. * Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90 days prior to screening. * Have ...
LY2963016 is an investigational basal insulin studied for use in diabetes mellitus, including Type 1 and Type 2 diabetes. It has been evaluated in healthy participants and in adult Chinese participants with Type 1 diabetes. The drug is being developed by Eli Lilly and Company as a potential treatment option for these metabolic conditions.
LY2963016 is a basal insulin, meaning it targets the insulin receptor to provide a long-acting, steady level of insulin activity. It is designed to mimic the body's basal insulin secretion to help control blood glucose levels in people with diabetes. The drug is compared against Lantus (insulin glargine) in clinical trials.
LY2963016 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. Eli Lilly is conducting clinical trials to evaluate the safety and efficacy of this basal insulin for the treatment of diabetes mellitus.
LY2963016 has completed Phase 1 and Phase 3 clinical trials. The Phase 1 studies evaluated the drug in healthy participants, while a Phase 3 study was conducted in adult Chinese participants with Type 1 diabetes. All trials listed for LY2963016 are completed, with no active trials currently ongoing.
LY2963016 has been studied in several completed clinical trials. These include NCT01374178 and NCT01688635, which compared LY2963016 to basal insulin or Lantus in healthy subjects, NCT02955953 comparing two formulations of insulin glargine, and NCT03338023, a Phase 3 study in Chinese participants with Type 1 diabetes.
LY2963016 is not the same as Lantus, but it is being studied as a potential biosimilar or comparable product to Lantus (insulin glargine). Clinical trials have directly compared LY2963016 to Lantus to assess similarity in pharmacokinetics and efficacy. The drug is an investigational basal insulin developed by Eli Lilly.