| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) | 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) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Least Squares Mean | Standard Error | percentage of HbA1c | | Baseline, 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered subcutaneous (SC) at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.13± 0.12
- OG001-1.12± 0.12
- OG002-1.19± 0.13
|
|
| | 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 |
|---|
| | Mixed Models Analysis | | <0.001 | | Mean Difference (Final Values) | -0.05 | | | 2-Sided | 95 | -0.26 | 0.15 | | | | | Non-Inferiority | Non-Inferiority to Glargine with a 0.4% margin | | | |
|
| Secondary | Percentage of Participants Whose HbA1c Was <7.0% | Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF). | All randomized participants who received at least one dose of study drug and had evaluable post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used | Posted | | Number | | percentage of participants | | 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Percentage of Participants Whose HbA1c Was <8.0% | Percentage of Participants whose HbA1c was <8.0% based on last observation carried forward (LOCF). | All randomized participants who received at least one dose of study drug and had evaluable post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Number | | percentage of participants | | 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG) | The daily mean of 8-point SMPG profile at Week 26 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime). | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and SMPG data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Least Squares Mean | Standard Error | milligrams/deciliter (mg/dL) | | Baseline, 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Change From Baseline in Fasting Glucose (FG) | LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and FG data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Least Squares Mean | Standard Deviation | milligram/deciliter (mg/dL) | | Baseline, 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | |
|
| Secondary | Change From Baseline in Mean Daily Insulin Lispro Dose | The mean daily insulin was based on a 4-week interval prior to week 26 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and insulin lispro dose data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Least Squares Mean | Standard Error | Units/day (U/day) | | Baseline, 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | |
|
| Secondary | Percentage of Participants With Estimated Average Glucose <154 mg/dL | Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF). | All randomized participants who received at least one dose of study drug and had evaluable HbA1c and average self-monitored plasma glucose post-baseline data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Number | | percentage of participants | | 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Change From Baseline in Serum Creatinine (sCr) | Change from baseline in serum creatinine (sCr) levels after treatment. | All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline sCr data. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
| |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) | The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline eGFR data. | Posted | | Median | Inter-Quartile Range | milliliter/minute/1.73m2 (mL/min/1.73m2) | | Baseline, 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Change From Baseline in Estimated Creatinine Clearance (eCrCl) | Estimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline eCrCl data. | Posted | | Median | Inter-Quartile Range | milliliter/minute (ml/min) | | Baseline, 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) | The change from baseline in Urinary Albumin to Creatinine Ratio (UACR). | All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline UACR data. | Posted | | Median | Inter-Quartile Range | gram/kilogram (g/kg) | | Baseline, 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
| |
| Secondary | Change From Baseline in Body Weight | LS means were calculated from a REML based MMRM model: Change from Baseline = treatment, week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured. • | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Least Squares Mean | Standard Error | kilogram (kg) | | Baseline, 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | |
|
| Secondary | Percentage of Participants With Self-Reported Hypoglycemic Events (HE) | Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. | All randomized participants who received at least one dose of study drug and had evaluable post-baseline HE data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Number | | percentage of participants | | Baseline through 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Rate of Hypoglycemic Events | Hypoglycemic events (HE) were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. | All randomized participants who had received at least one dose of study drug and had evaluable post-baseline HE rate data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Mean | Standard Deviation | Events/Participant/Year | | Baseline through 26 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine administered SC to be given at bedtime per sliding scale. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Change From Baseline in HbA1c | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means in HbA1c were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, MA region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Least Squares Mean | Standard Error | percentage of HbA1c | | Baseline, 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 |
|
| Secondary | Percentage of Participants Whose HbA1c is <7.0% | Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF). | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Number | | percentage of participants | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Percentage of Participants Whose HbA1c is <8.0% | Percentage of participants whose HbA1c was <8.0% based on last observation carried forward (LOCF). | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Number | | percentage of participants | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Change From Baseline in 8-Point SMPG | The daily mean of 8-point SMPG profile at Week 52 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime). | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and SMPG data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Change From Baseline in FG | LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and FG data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Change in Mean Daily Insulin Lispro Dose | The mean daily insulin was based on a 4-week interval prior to week 52 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and insulin lispro dose data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Least Squares Mean | Standard Error | U/day | | Baseline, 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 |
|
| Secondary | Percentage of Participants With Estimated Average Glucose <154 mg/dL | Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF). | All randomized participants who received at least one dose of study drug and had evaluable HbA1c and average self-monitored plasma glucose post-baseline data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Number | | percentage of participants | | 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
|
| Secondary | Change From Baseline in sCr | Change from baseline in sCr levels after treatment. | All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline sCr data. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
| |
| Secondary | Change From Baseline in eGFR | The change in eGFR by using CKD-EPI equation. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline eGFR data. | Posted | | Median | Inter-Quartile Range | mL/min/1.73m2 | | Baseline, 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
| |
| Secondary | Change From Baseline in eCrCl | eCrCl was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline eCrCl data. | Posted | | Median | Inter-Quartile Range | mL/min | | Baseline, 52 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
| |
| Secondary | Change From Baseline in UACR | The change from baseline in UACR | All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline UACR data. | Posted | | Median | Inter-Quartile Range | g/kg | | Baseline, 52 Weeks | | | | ID | Title | Description |
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| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
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| Secondary | Change From Baseline in Body Weight | LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Least Squares Mean | Standard Error | kg | | Baseline, 52 Weeks | | | | ID | Title | Description |
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| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | |
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| Secondary | Percentage of Participants With Self-Reported Hypoglycemic Events (HE) | Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. | All randomized participants who received at least one dose of study drug and had evaluable post-baseline HE data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Number | | percentage of participants | | Baseline through 52 Weeks | | | | ID | Title | Description |
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| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
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| Secondary | Rate of Hypoglycemic Events (HE) | HE were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section. | All randomized participants who had received at least one dose of study drug and had evaluable post-baseline HE rate data. Only measurements prior to rescue or study drug discontinuation were used. | Posted | | Mean | Standard Deviation | Events/Participant/Year | | Baseline through 52 Weeks | | | | ID | Title | Description |
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| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
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| Secondary | Participants With Events of Allergic/Hypersensitivity Reactions | Participants with Events of Allergic/Hypersensitivity Reactions: Angioedema Standardized MedDRA Query (SMQ), Anaphylactic Reaction SMQ, or Severe Cutaneous Adverse Reactions SMQ | All randomized participants who received at least one dose of study drug. | Posted | | Number | | participants with events | | Baseline through 52 Weeks | | | | ID | Title | Description |
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| OG000 | Insulin Glargine | Insulin glargine was administered SC at bedtime per a modified forced-titration treat-to-target algorithm. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG001 | Dulaglutide 0.75 mg | Dulaglutide 0.75 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. | | OG002 | Dulaglutide 1.5 mg | Dulaglutide 1.5 mg was administered once weekly as a SC injection. Participants were instructed to administer their titrated prandial insulin lispro dose SC with the three most significant meals of the day. |
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