Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...