| Primary | Event Rate of "All Hypoglycemia" Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year) | 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. | The efficacy population consisted of all randomized patients who received at least one dose of the study medication (modified intent-to-treat [mITT] population). For efficacy analyses, patients were analyzed in the treatment group allocated by the Interactive Voice Response System (IVRS) at randomization (as randomized). | Posted | | Mean | Standard Deviation | number of events per patient-year | | 6 months | | | | ID | Title | Description |
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| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000192.75± 119.28
- OG001168.91± 101.04
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The sample size was calculated to ensure sufficient power so that the upper bound of the 2-sided 95% CI for the Lantus /NPH ratio would not exceed 1.15 based on an expected overall rate of "all hypoglycemia" of 80 events per patient-year of exposure to NPH insulin and to Lantus. It was planned to randomize at least 45 and up to approximately 60 patients in each of the 2 treatment groups so that at least 70 patients would complete the 24 weeks of treatment. | Generalized Linear Model | A stepwise closed testing approach was used for the primary "all hypoglycemia" outcome analysis to assess noninferiority and superiority sequentially. | | | Risk Ratio (RR) | 1.18 | Standard Error of the Mean | 0.12 | 2-Sided | 95 | 0.97 | 1.44 | | | |
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| Secondary | Event Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year) | Symptomatic hypoglycemia: any event with clinical symptoms considered to result from hypoglycemia, validated by the study investigator based on data from patient diaries. | Same as for primary endpoint: mITT population. | Posted | | Mean | Standard Deviation | events per patient-year | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Secondary | Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years | Severe symptomatic hypoglycemia: any event with clinical symptoms considered to result from a hypoglycemic episode for which the patients required the assistance of a third party (ie, other than the patient, or a parent/usual caregiver; eg, from emergency personnel), because the patients/parents could not treat the event with acute neurological impairment directly resulting from the hypoglycemic event. The occurrence of seizure, coma, unconsciousness, or the use of glucagon, were also to qualify a hypoglycemic episode as severe. | Same as for primary endpoint: mITT population. | Posted | | Mean | Standard Deviation | number of events per patient-year | | 6 months | Episodes | Participants | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Secondary | Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of "All Hypoglycemia" Episodes Divided by the Total Duration of the On-treatment Period in Years | Nocturnal hypoglycemia: any event from the "all hypoglycemia" total that occurred between 23:00 and 07:00 hours. | Same as for primary endpoint: mITT population. | Posted | | Mean | Standard Deviation | number of events per patient-year | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Secondary | Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years | Nocturnal symptomatic hypoglycemia: any symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours. | Same as for primary endpoint: mITT population. | Posted | | Mean | Standard Deviation | number of events per patient-year | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Secondary | Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years | Severe nocturnal symptomatic hypoglycemia: any severe symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours. | Same as for primary endpoint: mITT population. | Posted | | Mean | Standard Deviation | number of events per patient-year | | 6 months | Episodes | Participants | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Secondary | Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment | | Same as for primary endpoint: mITT population. However post-baseline HbA1c values were missing for 9 patients: 2 patients in the Lantus group and 7 in the NPH group. | Posted | | Mean | Standard Deviation | percent HbA1c | | baseline, 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Secondary | Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates) | Assessed using an analysis of covariance (ANCOVA) model with treatment, and randomization strata (baseline number of CGM hypoglycemic excursions <0.5 events/24hours or ≥0.5 events/24 hours, and baseline HbA1c <8.5% or ≥8.5%) as fixed effects, and using the baseline value as covariate. | Same as for primary endpoint: mITT population. | Posted | | Least Squares Mean | Standard Error | percent HbA1c | | baseline, 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Secondary | Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit | Percentage of patients reaching International Society for Pediatric and Adolescent Diabetes (ISPAD)-recommended goals of Glycosylated Hemoglobin A1c <7.5% at the end of treatment visit. | The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with post-baseline HbA1c values. 2 patients from the Lantus group and 7 from the NPH group had no post-baseline HbA1c value. | Posted | | Number | | percentage of participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Secondary | Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment | | Same as for primary endpoint: mITT population. However 1 patient in the NPH group did not have baseline CGM value and 2 other patients (1 in the Lantus group and 1 in the NPH group) did not have on-treatment CGM values. | Posted | | Mean | Standard Deviation | mmol/L | | baseline, 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Other Pre-specified | Number of Patients With Different Types of Hypoglycemia Events | Definitions of the different types of hypoglycemia events provided in the outcome measure description of the corresponding event rates. | Same as for primary endpoint: mITT population. | Posted | | Number | | participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Other Pre-specified | Percent of Blood Glucose (BG) Within the Range of 70 - 180 mg/dL (3.9-10 mmol/L) | Calculated for each patient as the percent of all on-treatment CGMS values falling within the range of 70 - 180 mg/dL (3.9 - 10 mmol/L) inclusive. | The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM). | Posted | | Mean | Standard Deviation | percent of CGMS values within the range | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Other Pre-specified | Blood Glucose Variability Based on All On-treatment CGMS Values | Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded over all CGMS placements. | The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM). | Posted | | Mean | Standard Deviation | mmol/L | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Post-Hoc | Event Rate of "All Confirmed Low CGMS Excursions" (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year) | "All confirmed low CGMS excursions" consisted of all 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. | Same as for primary endpoint: mITT population. | Posted | | Mean | Standard Deviation | events per patient-year | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Post-Hoc | Event Rate of "All Confirmed Low FSBG" (Individual Component of the Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year) | "All confirmed low FSBG" consisted of all low FSBG readings (values <70 mg/dL) performed at other times. | Same as for primary endpoint: mITT population. | Posted | | Mean | Standard Deviation | events per patient-year | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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| Other Pre-specified | Nocturnal Blood Glucose Variability Based on All On-treatment CGMS Values | Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded during the nocturnal time period (between 23:00 and 07:00 hours). | The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM). | Posted | | Mean | Standard Deviation | mmol/L | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Lantus (Insulin Glargine) | Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. | | OG001 | NPH Insulin | Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection. Dose: titrated to achieve glycemic targets as described in protocol section. |
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