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Glargine · 3 trials · 2 indications
HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, stratification factors (country, baseline low density lipoprotein cholesterol \[LDL-C\] \[\<100 milligrams/deciliter (mg/dL) (2.6 millimoles/liter \[mmol/L\]) and ≥100 mg/dL (2.6 mmol/L)\], baseline prior basal insulin therapy \[insulin glargine/detemir/other\]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM), adjusting for treatment, stratification factors (baseline low-density lipoprotein cholesterol \[LDL-C\] \[\<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
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) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol \[LDL-C, \< 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL\] and sulfonylurea \[SU\]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects.
| Arm | Type | Description |
|---|---|---|
| LY2605541 + Insulin Lispro | EXPERIMENTAL | LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC) once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered SC at meal times for 52 weeks. |
| Glargine + Insulin Lispro | ACTIVE_COMPARATOR | Glargine dose titrated based on blood glucose readings, administered SC once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered SC at meal times for 52 weeks. |
| LY2605541 | EXPERIMENTAL | LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks |
| Glargine | ACTIVE_COMPARATOR | Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks |
| Name | Type | Description |
|---|---|---|
| Glargine | DRUG | - |
| LY2605541 | DRUG | - |
| Insulin Lispro | DRUG | - |
Inclusion Criteria: * Type 1 diabetes for at least 1 year * HbA1c value less than 12 percent according to the central laboratory at screening * Body mass index of less than or equal to 35.0 kilograms per square meter (kg/m\^2) * Have been treated for at least 90 days prior to screening with * in...
Glargine is used to treat type 1 and type 2 diabetes mellitus. It is being developed by Eli Lilly and Company for both indications. The clinical program includes Phase 3 studies in adults with type 1 diabetes and type 2 diabetes, evaluating its use in these metabolic conditions.
Glargine targets the insulin receptor (INSR) and acts as an agonist. By binding to and activating INSR, it mimics the action of endogenous insulin, thereby promoting glucose uptake and lowering blood glucose levels in patients with diabetes mellitus.
Glargine is being developed by Eli Lilly and Company, which trades under the ticker symbol LLY. The company is responsible for the clinical development program of this small molecule for the treatment of type 1 and type 2 diabetes mellitus.
Glargine is in Phase 3 clinical development. The program includes completed Phase 3 trials in type 1 and type 2 diabetes mellitus. It is an investigational product and has not been approved by the FDA for any indication.
Glargine has been studied in completed Phase 3 trials including NCT01481779 and NCT01454284 in type 1 diabetes, and NCT01435616 in type 2 diabetes. These randomized, double-blind, active-controlled studies enrolled a total of 1569 participants across multiple countries.