| Primary | Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles | 8-point SMBG profiles are measured at morning FBG, midday and evening pre-meal blood glucose (BG), 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. Least squares (LS) mean of the FBG is from mixed-model repeated measures (MMRM) approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-interim analysis [IA], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline hemoglobin A1c [HbA1c] group); visit; visit and treatment interaction; random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | millimoles per Liter (mmol/L) | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | | OG002 | LY2605541 Algorithm 2 | Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0006.83± 0.22
- OG0017.15± 0.22
- OG0026.84± 0.22
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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 | | 0.433 | The statistical significance level is 0.10. | Least Squares Mean Difference (Final) | 0.17 | | | 2-Sided | 90 | -0.18 | 0.52 | | | The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference. | | Superiority or Other | | |
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| Secondary | Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint | FBG is measured by 8-point SMBG profiles, which are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean of the change from baseline to 12 weeks is from MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | mmol/Liter | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Combined | LY2605541 Dosing Algorithm 1 + LY2605541 Dosing Algorithm 2 Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days Algorithm 2: Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
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| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Endpoint | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 dose algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; visit and treatment interaction; and a random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | percentage of glycated hemoglobin | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Combined | LY2605541 Dosing Algorithm 1 + LY2605541 Dosing Algorithm 2 Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days Algorithm 2: Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
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| Secondary | Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. | All randomized participants who took at least one dose of study drug, last observation carried forward (LOCF). Arms are combined due to | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Combined | Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days Algorithm 2: Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
| |
| Secondary | Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole/Liter (mmol/L) (≤70 milligram/deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). | All randomized participants who took at least one dose of study drug, last observation carried forward (LOCF). Arms are combined due to | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Combined | LY2605541 Dosing Algorithm 1 + LY2605541 Dosing Algorithm 2 Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days Algorithm 2: Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
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| Secondary | 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint | 8-point SMBG profiles are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Combined | LY2605541 Dosing Algorithm 1 + LY2605541 Dosing Algorithm 2 Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days Algorithm 2: Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
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| Secondary | Daily Basal Insulin Dose at Week 2 and Week 12 | LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | nanomole per kilogram (nmol/kg) | | Week 2 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Combined | LY2605541 Dosing Algorithm 1 + LY2605541 Dosing Algorithm 2 Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days Algorithm 2: Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
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| Secondary | Percentage of Participants With Hypoglycemia From Baseline Through Week 12 | Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). | All randomized participants who took at least one dose of study drug. | Posted | | Number | | percentage of participants | | Baseline through Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Combined | LY2605541 Dosing Algorithm 1 + LY2605541 Dosing Algorithm 2 Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days Algorithm 2: Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
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| Secondary | Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 | Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30. | All randomized participants who took at least one dose of study drug. | Posted | | Mean | Standard Deviation | Number of Hypoglycemia episodes/30 days | | Baseline through Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Combined | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
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| Secondary | Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16 | Negative is defined as either 'negative' from lab or percent binding <1.16%. Positive is defined as the percent binding is ≥1.16%. The antibody status change is from negative to positive or positive to negative. | All randomized participants who took at least one dose of study drug with both baseline and endpoint antibody measurements. | Posted | | Number | | percentage of participants | | Week 12 and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | | OG002 | LY2605541 Algorithm 2 | Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
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| Secondary | Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 | Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day at baseline, and each day between Week 10 and Week 12. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant. | All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline and Week12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Combined | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
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| Secondary | Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 12 Endpoint | The drug (LY2605541) concentration at steady state (Css) is calculated from the clearance (Liter/hour) and the final dose of the participants. Clearance was estimated using population-based approaches. | Participants who took at least one dose of study drug and had measurements at Week 12. | Posted | | Geometric Mean | Geometric Coefficient of Variation | picomoles per liter (pMol/L) | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | LY2605541 Combined | LY2605541 Dosing Algorithm 1 + LY2605541 Dosing Algorithm 2 Algorithm 1: Participants took both LY2605541 and their pre-study insulin for first several days Algorithm 2: Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
| |
| Secondary | Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms | FBG is measured by 8-point SMBG profiles, which are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean of the change from baseline to 12 weeks is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant. | All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | |
|
| Secondary | Change From Baseline in HbA1c at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; visit and treatment interaction; and a random effect for participant. | All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | percentage of glycated hemoglobin | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | | OG002 |
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| Secondary | Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. | All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, last observation carried forward (LOCF). | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | | OG002 | LY2605541 Algorithm 2 | Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
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| Secondary | Percentage of Participants Who Did Not Experience a Hypoglycemic Episode During Treatment With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). | All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, last observation carried forward (LOCF). | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | | OG002 | LY2605541 Algorithm 2 |
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| Secondary | 8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms | 8-point SMBG profiles are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant. | All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | nmol/L | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | | OG002 |
|
| Secondary | Daily Basal Insulin Dose at Week 2 and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms | LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant. | All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | nmol/kg | | Week 2 and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | | OG002 | LY2605541 Algorithm 2 | Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
|
| Secondary | Percentage of Participants With Hypoglycemia From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms | Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). | All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance. | Posted | | Number | | percentage of participants | | Baseline through Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | | OG002 | LY2605541 Algorithm 2 | Participants took only LY2605541 with first dose doubled Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks |
|
| Secondary | Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms | Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30. | All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance. | Posted | | Mean | Standard Deviation | Number of Hypoglycemia episodes/30 days | | Baseline through Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | | OG002 | LY2605541 Algorithm 2 | |
|
| Secondary | Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms | Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day at baseline, and each day between Week 10 and Week 12. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant. | All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value. | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks | | OG001 | LY2605541 Algorithm 1 | Participants took both LY2605541 and their pre-study insulin for first several days Subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks | | OG002 |
|