Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2963016 · 11 trials · 7 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.
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. |
| 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 |
| 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 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 |
| 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 insulin glargine product being studied for the treatment of Type 1 and Type 2 Diabetes Mellitus. It is a small molecule in the metabolic therapeutic area, developed by Eli Lilly and Company. Clinical trials have evaluated it in adults with Type 2 Diabetes and in healthy participants.
LY2963016 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The company has sponsored clinical trials of this investigational insulin glargine product across multiple countries, including the United States, China, and Singapore.
LY2963016 has completed Phase 1 and Phase 3 clinical trials. It is an investigational product, not yet approved by regulatory authorities. The completed trials include Phase 1 studies in healthy participants and Phase 3 studies in patients with Type 2 Diabetes Mellitus.
LY2963016 has been studied in four completed clinical trials. NCT01421459 was a Phase 3 study in 759 adults with Type 2 Diabetes. NCT01688635 and NCT02955953 were Phase 1 studies in healthy participants. NCT03338010 was a Phase 3 study in 536 Chinese adults with Type 2 Diabetes.
LY2963016 is being compared to Lantus (insulin glargine) in clinical trials. Studies such as NCT01688635 and NCT03338010 directly compared LY2963016 to US-approved Lantus or Lantus in patients with Type 2 Diabetes. LY2963016 is an insulin glargine product intended to be similar to Lantus.
LY2963016 is an insulin glargine product, which is a long-acting form of insulin used to control blood sugar levels. It works by replacing the insulin that the body normally produces, helping to regulate glucose metabolism in patients with diabetes mellitus.