Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Neutral Protamine Hagedorn insulin · 1 trial · 1 indication
The rate of "all hypoglycemia" was calculated from "all hypoglycemia" episodes which occurred during the 24-week on-treatment period and consisted of: - symptomatic hypoglycemia episodes validated by the study investigator based on entries in patients' diaries, - low continuous glucose monitoring system (CGMS) excursions (interstitial glucose \<70 mg/dL \[3.9 mmol/L\]) confirmed by fingerstick blood glucose (FSBG) \<70 mg/dL, - low FSBG readings (values \<70 mg/dL) performed at other times.
| Arm | Type | Description |
|---|---|---|
| Lantus (insulin glargine) | EXPERIMENTAL | Lantus given as basal insulin once a day in the morning by subcutaneous injection |
| NPH insulin | ACTIVE_COMPARATOR | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day generally in the morning and /or at bedtime by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Insulin glargine (HOE901) | DRUG | 100 U/mL commercial solution for injection available as both disposable pen devices Solostar® each containing 300 U and as 10 mL vials each containing 1000 U Dose: titrated to achieve the following glycemic targets without hypoglycemia: * Fasting blood glucose (BG) between 90 and 145 mg/dL (5.0 to 8.0 mmol/L), inclusive, * Bedtime BG between 120 and 180 mg/dL (6.7 to10.0 mmol/L), inclusive, * Nocturnal BG between 80 and 162 mg/dL (4.4 to 9.0 mmol/L), inclusive; and * HbA1c \<7.5%. |
| Neutral Protamine Hagedorn (NPH) insulin | DRUG | NPH insulin 100 U/mL commercial (Huminsulin Basal) solution for injection available as both disposable pen devices (Huminsulin Basal Pen) each containing 300 U and as 10 mL vials each containing 1000 U Dose: titrated to achieve glycemic targets as described above for insulin glargine |
| Insulin lispro | DRUG | Insulin lispro used as the principal bolus insulin; regular human insulin permitted. Administration: multiple injection before meals and/or at bedtime at the discretion of the Investigator. |
Inclusion criteria: * Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study Exclusion criteria: * Diagnosis of type 1 diabetes ...
Neutral Protamine Hagedorn insulin is used for Type 1 Diabetes Mellitus. It is an investigational small molecule being developed by Sanofi. The drug is currently in Phase 3 clinical development, meaning it has not yet been approved and is still being studied for safety and efficacy in patients.
Sanofi (ticker: SNY) is developing Neutral Protamine Hagedorn insulin. The company is conducting clinical trials to evaluate the drug for the treatment of Type 1 Diabetes Mellitus. As of the latest data, the drug is in Phase 3 development.
Neutral Protamine Hagedorn insulin is in Phase 3 clinical development. It is an investigational drug for Type 1 Diabetes Mellitus and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with a total enrollment of 125 participants.
Neutral Protamine Hagedorn insulin has one completed Phase 3 trial, NCT00993473, titled "6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes." The trial enrolled 125 participants across multiple countries, including the United States, Austria, Brazil, and Chile.
Neutral Protamine Hagedorn insulin is not the same as Lantus. In the clinical trial NCT00993473, Lantus was used as an active comparator against Neutral Protamine Hagedorn insulin. The two are distinct products, and the trial compared their effects in young children with Type 1 Diabetes Mellitus.