Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NPH · 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...
NPH is an investigational small molecule being studied for the treatment of diabetes during pregnancy. It is currently in Phase 2 clinical development. NPH is being evaluated in a completed clinical trial for this condition, though it is not yet approved and remains under investigation.
NPH is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical research on NPH for the treatment of diabetes during pregnancy.
NPH is in Phase 2 clinical development. It has completed one Phase 2 trial for diabetes during pregnancy. NPH is an investigational drug and has not been approved by regulatory authorities, as it is still in the clinical development process.
NPH has been studied in one completed Phase 2 clinical trial, identified as NCT01662921. This trial, titled "Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes," enrolled 17 female participants aged 18 years and older in the United States.
NPH was studied in a comparator trial against insulin glulisine and insulin lispro for gestational diabetes, but NPH itself is a distinct investigational drug. The trial was active-controlled, meaning NPH was compared to these other treatments, but NPH is not the same as either of them.