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Label indication BASAGLAR ® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. BASAGLAR ® is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. FDA label
Also known as LY2963016, Insulin Glargine (U100), Lantus, Basaglar
Insulin Glargine · 13 trials · 6 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.
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 | 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 |
| 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 |
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 ...
Insulin Glargine is used to treat diabetes mellitus, including type 1 diabetes and type 2 diabetes. It is being developed by Eli Lilly and Company for these metabolic indications. Clinical studies have enrolled adults with type 1 and type 2 diabetes, including participants in China, the United States, India, and other countries.
Insulin Glargine targets INSR, the insulin receptor, and acts as an agonist at that receptor. By activating the insulin receptor, it supports glucose-lowering activity relevant to diabetes management. This target class is consistent with its use in type 1 and type 2 diabetes mellitus.
Insulin Glargine is developed by Eli Lilly and Company, which trades under the ticker LLY. Lilly has run clinical studies of the drug in adult participants with type 1 and type 2 diabetes, including comparator studies against Lantus in Chinese and multinational populations.
Insulin Glargine is in Phase 1 development according to its current development stage, and it is investigational rather than approved. Completed studies include Phase 3 trials, such as NCT03338023 and NCT03338010 in Chinese adults and NCT02302716 in a multinational type 2 diabetes population.
Insulin Glargine has been studied in completed trials including NCT04957914 in type 2 diabetes, NCT03338023 in type 1 diabetes, NCT03338010 in type 2 diabetes, and NCT02302716 in type 2 diabetes. These studies were randomized, double-blind, and active-controlled, with total enrollment across the program of 3,374 participants.
Yes, Insulin Glargine is also known as LY2963016 and Insulin Glargine (U100). LY2963016 is the Lilly development code used in trial titles such as NCT03338023, NCT03338010, and NCT02302716, which compared it with Lantus in adults with type 1 or type 2 diabetes.