Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00993473 | 6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes | PHASE3 | COMPLETED | 125 | — | — | Oct 1, 2009 | Mar 1, 2011 | Jun 27, 2012 | 61 | United States, Austria +14 |
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 ...