| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16 | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. | All randomized participants with baseline and at least one post-baseline HbA1c data. | Posted | | Least Squares Mean | Standard Error | Percentage of HbA1c | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.09± 0.030
- OG001-0.06± 0.031
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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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| | Mixed Models Analysis | | 0.565 | | Mean Difference (Final Values) | 0.02 | | | 2-Sided | 95 | -0.06 | 0.11 | | | | | Non-Inferiority | Noninferiority margin = 0.4% for HbA1c | |
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| Secondary | Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16 | A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. | All randomized participants with baseline and at least one post-baseline 1-hour PPG data. | Posted | | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16 | A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. | All randomized participants with baseline and at least one post-baseline 2-hour PPG data. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16 | Percentage of time with sensor glucose values between 70 and 180 mg/dL using continuous glucose monitoring (CGM). Least square (LS) mean difference will provided for CGM data normalized to a 24hrs period. Daytime: 0600 hours to midnight (06:00:00-23:59:59 on the 24-hour clock). Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | percentage of time | | Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Rate of Severe Hypoglycemia at Week 16 | Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525. | All randomized participants with evaluable hypoglycemic data. | Posted | | Number | | Events per 100 participant years | | Baseline through Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Rate of Documented Symptomatic Hypoglycemia at Week 16 | Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable. | All randomized participants with evaluable hypoglycemic data. | Posted | | Least Squares Mean | Standard Error | Events per participant per year | | Baseline through Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16 | 1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug. | All randomized participants with baseline and at least one post-baseline 1,5-AG data. | Posted | | Least Squares Mean | Standard Error | milligram per liter (mg/L) | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16 | SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, HbA1c stratum : less than or equal to (≤)7.5%, greater than (>)7.5% and participant's personal CGM or FGM use during the study), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug. | All randomized participants with baseline and at least one post-baseline SMBG data. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Change From Baseline in Insulin Dose at Week 16 | LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug. | All randomized participants with baseline and at least one post-baseline basal insulin dose data. | Posted | | Least Squares Mean | Standard Error | units per day (U/day) | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16 | The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit. LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug. | All randomized participants with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | Percentage of bolus/total insulin dose | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Percentage of Participants With HbA1c <7% | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | All randomized participants with baseline and at least one post-baseline HbA1c <7% data. Missing endpoints were imputed by applying the Last Observation Carried Forward (LOCF) method to the post-baseline data. | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change | Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated. | All randomized participants with baseline and at least one post-baseline value. | Posted | | Number | | Percentage of participants | | Baseline through Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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| Secondary | Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia >300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change | Percentage of participants with at least 1 event of unexplained hyperglycemia >300 milligrams per deciliter (mg/dL) confirmed by SMBG that leads to an unplanned infusion set change was evaluated. | All randomized participants with baseline and at least one post-baseline value. | Posted | | Number | | Percentage of participants | | Baseline through Week 16 | | | | ID | Title | Description |
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| OG000 | Insulin Lispro (Humalog) | Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. | | OG001 | Ultra-Rapid Lispro | Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary. |
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