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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IOQC | Other Identifier | Eli Lilly and Company |
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Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on basal insulin.
Participants who enter the study and are already taking insulin glargine with a screening HbA1c >7.0% will be randomized to one of two treatment arms. Both arms will add prandial insulin to existing basal insulin therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 Day Algorithm | Experimental | Basal insulin glargine plus mealtime bolus insulin lispro titrated based on blood glucose readings from the past three days. (Sites were assigned to Study A and Study B according to an allocation plan that was pre-specified before initiation of Study A and Study B) |
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| Daily Algorithm | Experimental | Basal insulin glargine plus mealtime bolus insulin lispro titrated based on blood glucose readings from the previous day. (Sites were assigned to Study A and Study B according to an allocation plan that was pre-specified before initiation of Study A and Study B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin lispro | Drug | Administered subcutaneously, up to three times daily for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 24 Week Endpoint in Glycated Hemoglobin (HbA1c) | The change from baseline to 24 weeks in the percentage of HbA1c in plasma. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: fixed effects for treatment, country, sulfonylurea/meglitinide use, visit, treatment by visit interaction with baseline HbA1c as a covariate. | Baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) Target Values | Percentage of participants who achieved HbA1c levels of ≤7.0% or ≤6.5%. | 24-week endpoint |
| Percentage of Participants ≥65 Years of Age Achieving Glycated Hemoglobin (HbA1c) Target Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Phoenix | Arizona | 85050 |
Protocol had 2 independent studies (Study A, Study B) from which data was analyzed separately and independently: Participants were randomized to 1of the 2 treatment arms (Q1D, Q3D) at the site level. Sites were assigned to a study according to an allocation plan that was pre-specified before initiation of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study A Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Glargine | Drug | Administered subcutaneously, dosage determined by investigator once daily for 24 weeks |
|
Percentage of participants ≥65 years of age achieving HbA1c target concentration of ≤7.0% or ≤6.5%. |
| 24-week endpoint |
| Change From Baseline to 24 Week Endpoint in Body Weight | Body weight was measured twice at each indicated visit and the average of the 2 measurements was used for analyses. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction . | Baseline, 24-weeks |
| Time to Reach Glycated Hemoglobin (HbA1c) Target Values | Percentage of participants is the number of participants who achieved HbA1c target values of ≤6.5% or ≤7.0% during the specified time period divided by the total number of participants who did not discontinue from the study but had not reached HbA1c target at the beginning of the specified post baseline time period (≤100 days and ≥101 days). Participants who did not experience an outcome before discontinuation or completion of the study were censored using the date of discontinuation. Participants who were lost to follow up the date of discontinuation were considered to be the date of last contact. | Baseline through 24 weeks |
| Change From Baseline to 24 Week Endpoint in Fasting Glucose | Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | Baseline, 24 weeks |
| Change From Baseline to 24 Week Endpoint in Fasting Glucose in Participants ≥65 Years of Age | Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | Baseline, 24 weeks |
| Change From Baseline to 24 Week Endpoint in 1,5-anhydroglucitol (1,5-AG) | Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | Baseline, 24 weeks |
| Change From Baseline to 24 Weeks in 7-Point Self-Monitored Blood Glucose (SMBG) Profile | 7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 time a day at the morning pre-meal, morning 2-hours (HR) postprandial (PP), midday pre-meal, midday 2-hours post-meal, evening pre-meal, bedtime and 0300 hour (3 am). Each participant took measures over any 3 days and the average was calculated for each of the 7 time points. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | Baseline, 24 weeks |
| Daily Dose of Insulin: Total, Basal and Prandial (Bolus) | Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | 24 weeks |
| Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial (Bolus) | Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Total, basal and prandial amounts were then divided by the participant's body weight in kilograms (kg). Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | 24 weeks |
| The Number of Participants With a Hypoglycemic Episode (Incidence) | A hypoglycemic episode was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines). | Randomization through 24 weeks overall |
| The Number of Participants ≥65 Years of Age With Hypoglycemic Episodes (Incidence) | A hypoglycemic episode in participants ≥ 65 years of age was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines). | Randomization through 24 weeks overall |
| The Rate of Hypoglycemic Episodes | The hypoglycemia rate per 30 days was calculated as the number of hypoglycemic episodes reported divided by the number of days at risk times 30. | Randomization through 24 weeks overall |
| Percentage of Participants With Severe Hypoglycemic Episodes | Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by low plasma glucose. | Randomization up to 24 weeks |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Concord | California | 94520 | United States |
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| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rio Piedras | 00921 | Puerto Rico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Juan | 00917 | Puerto Rico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bucharest | 022441 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Oradea | 410169 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saint Petersburg | 197022 | Russia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Saratov | 410053 | Russia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Stavropol | 355035 | Russia |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Halfway House | 1685 | South Africa |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Somerset West | 7130 | South Africa |
| FG001 | Study A Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A. |
| FG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| FG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set-all participants who entered this study, completed the lead-in period (if applicable), were randomized and received ≥1 dose of study insulin, except the participants from the site excluded due to quality issues and data validity.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study A Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A. |
| BG001 | Study A Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based dose was on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A. |
| BG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| BG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to 24 Week Endpoint in Glycated Hemoglobin (HbA1c) | The change from baseline to 24 weeks in the percentage of HbA1c in plasma. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: fixed effects for treatment, country, sulfonylurea/meglitinide use, visit, treatment by visit interaction with baseline HbA1c as a covariate. | Full Analysis Set: All participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with a baseline value for HbA1C, except participants from the excluded site. | Posted | Least Squares Mean | Standard Error | percentage HbA1c | Baseline, 24 weeks |
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| Secondary | Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) Target Values | Percentage of participants who achieved HbA1c levels of ≤7.0% or ≤6.5%. | Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, except participants from the excluded site; last observation carried forward (LOCF) was used. | Posted | Number | percentage of participants | 24-week endpoint |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants ≥65 Years of Age Achieving Glycated Hemoglobin (HbA1c) Target Concentration | Percentage of participants ≥65 years of age achieving HbA1c target concentration of ≤7.0% or ≤6.5%. | A subset of the Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and were ≥65 years of age, except participants from the excluded site. Last observation carried forward (LOCF) was used. | Posted | Number | percentage of participants | 24-week endpoint |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 24 Week Endpoint in Body Weight | Body weight was measured twice at each indicated visit and the average of the 2 measurements was used for analyses. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction . | Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized and received ≥1 dose of study insulin with a baseline body weight, except participants from the excluded site. | Posted | Least Squares Mean | Standard Error | kilograms (kg) | Baseline, 24-weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Glycated Hemoglobin (HbA1c) Target Values | Percentage of participants is the number of participants who achieved HbA1c target values of ≤6.5% or ≤7.0% during the specified time period divided by the total number of participants who did not discontinue from the study but had not reached HbA1c target at the beginning of the specified post baseline time period (≤100 days and ≥101 days). Participants who did not experience an outcome before discontinuation or completion of the study were censored using the date of discontinuation. Participants who were lost to follow up the date of discontinuation were considered to be the date of last contact. | Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, except participants from the excluded site. Censored participants: Study A: ≤6.5% Q1D=186 and Q3D=197; Study A ≤7.0% Q1D=120 and Q3D=134; Study B: ≤6.5% Q1D=206 and Q3D=212, Study B ≤7.0% Q1D=135 and Q3D=152. | Posted | Number | percentage of participants | Baseline through 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 24 Week Endpoint in Fasting Glucose | Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with baseline fasting glucose values, except participants from the excluded site. | Posted | Least Squares Mean | Standard Error | millimoles/liter (mmoles/L) | Baseline, 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 24 Week Endpoint in Fasting Glucose in Participants ≥65 Years of Age | Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | A subset of the Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, who are ≥65 years of age with baseline fasting glucose values, except participants from the excluded site. | Posted | Least Squares Mean | Standard Error | millimoles/liter (mmoles/L) | Baseline, 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 24 Week Endpoint in 1,5-anhydroglucitol (1,5-AG) | Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with baseline 1,5-AG value, except participants from the excluded site. | Posted | Least Squares Mean | Standard Error | microgram/milliliter (mcg/mL) | Baseline, 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 24 Weeks in 7-Point Self-Monitored Blood Glucose (SMBG) Profile | 7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 time a day at the morning pre-meal, morning 2-hours (HR) postprandial (PP), midday pre-meal, midday 2-hours post-meal, evening pre-meal, bedtime and 0300 hour (3 am). Each participant took measures over any 3 days and the average was calculated for each of the 7 time points. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and had values at baseline and the specified timepoint, except participants from the excluded site. | Posted | Least Squares Mean | Standard Error | milligrams/deciliter (mg/dL) | Baseline, 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Daily Dose of Insulin: Total, Basal and Prandial (Bolus) | Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and with values in the specified category, except participants from the excluded site. | Posted | Least Squares Mean | Standard Error | international units (IU) | 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial (Bolus) | Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Total, basal and prandial amounts were then divided by the participant's body weight in kilograms (kg). Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction. | Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and with values in the specified category, except participants from the excluded site. | Posted | Least Squares Mean | Standard Error | international units/kilogram (IU/kg) | 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With a Hypoglycemic Episode (Incidence) | A hypoglycemic episode was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines). | All randomized participants except from the excluded site. | Posted | Number | participants | Randomization through 24 weeks overall |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants ≥65 Years of Age With Hypoglycemic Episodes (Incidence) | A hypoglycemic episode in participants ≥ 65 years of age was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines). | All randomized participants ≥65 years old except those from the excluded site. | Posted | Number | participants | Randomization through 24 weeks overall |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Rate of Hypoglycemic Episodes | The hypoglycemia rate per 30 days was calculated as the number of hypoglycemic episodes reported divided by the number of days at risk times 30. | All randomized participants except those from the excluded site. | Posted | Mean | Standard Deviation | hypoglycemic episodes per 30 day period | Randomization through 24 weeks overall |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Severe Hypoglycemic Episodes | Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by low plasma glucose. | All randomized participants except those from the excluded site. | Posted | Number | percentage of participants | Randomization up to 24 weeks |
|
Not provided
The number of participants at risk does not include 3 participants in Study B Q1D and 2 participants in Study B Q3D who were from the site excluded due to quality issues and data validity.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study A Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A. | 21 | 268 | 136 | 268 | ||
| EG001 | Study A Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A. | 17 | 263 | 142 | 263 | ||
| EG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. | 21 | 289 | 130 | 289 | ||
| EG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. | 27 | 292 | 150 | 292 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment | Event resulted in death in arm Study A Q1D |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Adrenal mass | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Rickettsiosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment | Event resulted in death in arm Study A Q1D |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase mb increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment | Event resulted in death |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinopathy | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
Five (5) randomized participants (3 Study B Q1D, 2 Study B Q3D) from 1 site were excluded from efficacy and safety analyses due to quality issues and validity of the data at that site.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
Not provided
Not provided
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Austria |
|
| Brazil |
|
| Canada |
|
| Croatia |
|
| Denmark |
|
| France |
|
| Lithuania |
|
| Mexico |
|
| Poland |
|
| Puerto Rico |
|
| Romania |
|
| Russian Federation |
|
| South Africa |
|
| United States |
|
| LS Mean Difference |
| 0.06 |
| 2-Sided |
| 95 |
| -0.12 |
| 0.24 |
No imputation was performed. Participants without a 24-week value were handled by the statistical model. |
| No |
| Superiority or Other |
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| Study A Q3D |
Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A. |
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A. |
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| Study B Q1D |
Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|
| OG002 | Study B Q1D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
| OG003 | Study B Q3D | Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D). Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks. Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B. |
|
|
|