| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®) | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated using mixed-effects model for repeated measures (MMRM) with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time*Treatment (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and postbaseline HbA1c value. | Posted | | Least Squares Mean | Standard Error | Percentage of HbA1c | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.20± 0.071
- OG001-0.08± 0.071
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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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| | | | | | Mean Difference (Net) | -0.12 | | | 2-Sided | 95 | -0.32 | 0.08 | | | | | Non-Inferiority | Noninferiority of LY2963016 to Lantus® was demonstrated at the 0.4% noninferiority margin and over 80 percent power. | |
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| Secondary | Change From Baseline in HbA1c (Lantus® Noninferior to LY2963016) | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was calculated using MMRM with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time*Treatment (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and postbaseline HbA1c value. | Posted | | Least Squares Mean | Standard Error | Percentage of HbA1c | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values | The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Before Morning Meal Glucose, 2 Hours After Morning Meal Glucose, Before Mid-Day Meal Glucose, 2 Hours After Mid-Day Meal Glucose, Before Evening Meal Glucose, Bedtime Glucose and 0300 Am Glucose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and postbaseline SMBG value. | Posted | | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Percentage of Participants With HbA1c <7% | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. | All randomized participants who received at least one dose of study drug and had baseline and postbaseline HbA1c value. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Percentage of Participants With HbA1c ≤6.5% | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. | All randomized participants who received at least one dose of study drug and had baseline and postbaseline HbA1c value. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Change From Baseline in Intrapatient Blood Glucose (BG) Variability, Measured by the Standard Deviation of 7-point SMBG | Change From Baseline in Intrapatient blood glucose (BG). LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and postbaseline SMBG value. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Change From Baseline in Glycemic Variability of Fasting Blood Glucose | Change From Baseline in Glycemic Variability of Fasting Blood Glucose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and postbaseline SMBG value. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Change From Baseline in Basal Insulin Dose | Change from baseline in basal insulin dose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. | All randomized participants who received at least one dose of study drug and had a baseline and postbaseline Basal Insulin dose value. | Posted | | Least Squares Mean | Standard Error | Units per Day (U/day) | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Change From Baseline in Prandial Insulin Dose | Prandial Insulin Dose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. | All randomized participants who received at least one dose of study drug and had a baseline and postbaseline Prandial Insulin dose value. | Posted | | Least Squares Mean | Standard Error | U/day | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Change From Baseline in Body Weight | Change from baseline in body weight. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. | All randomized participants who received at least one dose of study drug and had a baseline and postbaseline weight value. | Posted | | Least Squares Mean | Standard Error | kilograms (kg) | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) | The ITSQ is a validated 22-item questionnaire that was used to assess treatment satisfaction. Items were measured on a 7-point scale, with lower scores reflecting better outcomes. In addition to an overall score, scores were also obtained for 5 domains, including inconvenience of regimen, lifestyle flexibility, glycemic control, hypoglycemic control, and insulin delivery device. Raw domain and overall scores were transformed on a scale from 0 to 100, where a higher score indicated better treatment satisfaction. LS mean was calculated using ANCOVA with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment (Type III sum of squares). | All randomized participants who received at least one dose of study drug and had a baseline and postbaseline ITSQ score. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Number of Participants With Detectable Anti-Glargine Antibodies | Number of participants with detectable anti-glargine antibodies | All participants who received at least one dose of study drug.Only participants with detected or non-detected insulin antibody levels at baseline and post-baseline were included in analysis. | Posted | | Count of Participants | | Participants | No | Baseline through Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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| Secondary | Rate of Documented Symptomatic Hypoglycemia | Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable. | All randomized participants who received at least one dose of study drug. | Posted | | Least Squares Mean | Standard Error | events/participant/year | | Baseline through Week 24 | | | | ID | Title | Description |
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| OG000 | LY2963016 + Insulin Lispro | Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. | | OG001 | Lantus® + Insulin Lispro | Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal. |
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