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Label indication ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 ) FDA label
Also known as Humalog
insulin lispro · 1 trial · 1 indication
compare average 1-hour post prandial SMBG measurements between patients randomized to insulin glulisine or insulin lispro
| Arm | Type | Description |
|---|---|---|
| NPH and insulin lispro | ACTIVE_COMPARATOR | Patients diagnosed with diabetes during pregnancy will be randomized to long acting insulin NPH and short acting insulin lispro in a basal bolus regimen to treat post prandial hyperglycemia using a dosing schedule of 50% NPH calculated by the patients weight and gestational age and 50% lispro pending their last three SMPG average. |
| NPH and insulin glulisine | ACTIVE_COMPARATOR | Patients with a diagnosis of diabetes during pregnancy will be randomized to using long acting insulin NPH and short acting insulin glulisine as treatment for post prandial hyperglycemia with a 50% NPH dosing schedule based on the weight and gestational age and 50% glulisine schedule based on their last three SMBG result average. |
| Name | Type | Description |
|---|---|---|
| NPH | DRUG | Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age |
| Insulin LISPRO | DRUG | Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days |
| Insulin glulisine | DRUG | Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days |
Inclusion Criteria: * Informed Consent to participate in clinical trial * Pregnant and 20-30 weeks gestation * Diagnosed with gestational diabetes * Failed diet therapy (failed lifestyle modification will be defined as 10% or greater SMBG values above pre-meal \<90mg/dL and post prandial \< 120mg/d...
Insulin lispro is a rapid-acting insulin being studied for the treatment of diabetes during pregnancy, including gestational diabetes. A Phase 2 trial compared it with insulin glulisine in pregnant women with this condition. It is used to help manage blood glucose levels in this patient population.
Insulin lispro acts as an agonist at the insulin receptor (INSR). By binding to and activating this receptor, it mimics the action of endogenous insulin, promoting glucose uptake into cells and lowering blood glucose levels. This mechanism underlies its use in managing diabetes during pregnancy.
Sanofi is the developer of insulin lispro for diabetes during pregnancy. The company trades on the New York Stock Exchange under the ticker SNY. Sanofi is responsible for the clinical development program evaluating this rapid-acting insulin in pregnant women with diabetes.
Insulin lispro is in Phase 2 clinical development for diabetes during pregnancy. It is investigational and has not been approved by the FDA for this specific indication. The Phase 2 trial has been completed, and no active trials are currently listed for this use.
Insulin lispro was evaluated in a completed Phase 2 trial, NCT01662921, titled "Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes." The trial enrolled 17 women aged 18 years and older in the United States and used an active-controlled, randomized design.