Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glargine · 4 trials · 3 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 |
| 2 | ACTIVE_COMPARATOR | Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications. |
| 1 | ACTIVE_COMPARATOR | Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications. |
| Name | Type | Description |
|---|---|---|
| Glargine | DRUG | - |
| LY2605541 | DRUG | - |
| Insulin Lispro | DRUG | - |
| Insulin lispro mix 25 | DRUG | Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications. |
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 an investigational small molecule being developed for the treatment of Type 1 and Type 2 Diabetes Mellitus. It is currently in Phase 3 clinical development and has been studied in patients with both forms of diabetes.
Glargine is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting Phase 3 clinical trials for this investigational diabetes treatment.
Glargine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Completed Phase 3 trials have evaluated its use in patients with Type 1 and Type 2 Diabetes Mellitus.
Glargine has been studied in several completed Phase 3 trials. These include NCT00551356 in Type 2 diabetics in Mexico, NCT01435616 in Type 2 diabetes across multiple countries, and NCT01454284 and NCT01481779 in Type 1 diabetes, all with completed status.
Glargine is classified as a small molecule therapeutic. It is being developed for metabolic conditions, specifically for the treatment of Type 1 and Type 2 Diabetes Mellitus, and has been evaluated in active-controlled clinical trials.