Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).
Interventions
DRUGInsulin Glargine
patient glucose-level dependent, injection, once daily in the evening, 24 weeks
DRUGInsulin Lispro Protamine Suspension (ILPS)
patient glucose-level dependent, injection, once daily in the evening, 24 weeks
DRUGInsulin Lispro
subcutaneous injections prior to meals, 24 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetes Mellitus, Type 2 * Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening) * Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0% * Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m\^2 * Capable and willing to follow the protocol * Give written consent
Exclusion criteria
* Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above) * Have a history of severe hypoglycemia in the past 6 months * Are pregnant or may become pregnant * Women who are breastfeeding * Have significant cardiac disease * Have significant renal or liver disease * Undergoing therapy for a malignancy * Contraindications to the study medications * Have an irregular sleep/wake cycle * Have a serious disease or any condition considered by the investigator to be exclusionary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24 | Baseline, Week 24 | Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint | Week 24 | — |
| 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | 24 weeks | LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal. |
| Glycemic Variability at Endpoint | Week 24 | LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements. |
| Rate Of All Self-reported Hypoglycemic Episodes | Baseline through Week 24 | Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose. |
| Change From Baseline in HbA1c at Week 12 and Week 24 | Baseline, Week 12, Week 24 | LSMean values presented were controlled for treatment, country, baseline HbA1C value and week. |
| Number of Participants With Adverse Events (AE) | Baseline through Week 24 | A listing of adverse events is located in the Reported Adverse Event module. |
| Change in Body Weight From Baseline to Week 24 | Baseline, Week 24 | LSMean values presented were controlled for treatment, country, and baseline HbA1C value. |
| Total Daily Insulin Dose at Endpoint | Week 24 | LSMean values presented were controlled for treatment, country, and baseline HbA1C value. |
| Number of Injections of Insulin at Week 24 | Week 24 | — |
| Percentage of Participants With Self-Reported Hypoglycemic Episodes | Baseline through Week 24 | Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose. |
Countries
Belgium, Czechia, Germany, Greece, Italy, Poland, Romania, Slovakia, Turkey (Türkiye), United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glargine Glargine plus Insulin Lispro (2-3 injections) plus metformin | 187 |
| ILPS Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin | 187 |
| Total | 374 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Entry Criteria Not Met | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 7 | 12 |
Baseline characteristics
| Characteristic | ILPS | Glargine | Total |
|---|---|---|---|
| Age Continuous | 59.3 years STANDARD_DEVIATION 8.36 | 60.3 years STANDARD_DEVIATION 8.07 | 59.8 years STANDARD_DEVIATION 8.22 |
| Body Mass Index (BMI) | 33.00 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 5.004 | 33.27 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 5.04 | 33.13 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 5.017 |
| Body Weight | 90.60 kilograms (kg) STANDARD_DEVIATION 17.075 | 93.53 kilograms (kg) STANDARD_DEVIATION 17.168 | 92.06 kilograms (kg) STANDARD_DEVIATION 17.161 |
| Duration of Diabetes | 11.8 Years STANDARD_DEVIATION 6.66 | 12.7 Years STANDARD_DEVIATION 7.04 | 12.3 Years STANDARD_DEVIATION 6.86 |
| Hemoglobin A1c (HbA1c) | 8.82 Percent of glycosylated hemoglobin STANDARD_DEVIATION 0.895 | 8.83 Percent of glycosylated hemoglobin STANDARD_DEVIATION 0.896 | 8.82 Percent of glycosylated hemoglobin STANDARD_DEVIATION 0.894 |
| Number of Insulin Injections/Inhalations Per Day 1 Insulin Injection/Inhalation per day | 106 Participants | 104 Participants | 210 Participants |
| Number of Insulin Injections/Inhalations Per Day 2 Insulin Injections/Inhalations per day | 34 Participants | 31 Participants | 65 Participants |
| Number of Insulin Injections/Inhalations Per Day 3 Insulin Injections/Inhalations per day | 32 Participants | 30 Participants | 62 Participants |
| Number of Insulin Injections/Inhalations Per Day 4 Insulin Injections/Inhalations per day | 14 Participants | 16 Participants | 30 Participants |
| Number of Insulin Injections/Inhalations Per Day >=5 Insulin Injections/Inhalations per day | 0 Participants | 6 Participants | 6 Participants |
| Number of Insulin Injections/Inhalations Per Day Missing Data | 1 Participants | 0 Participants | 1 Participants |
| Previous Insulin Treatment | 37.6 Units (IU) STANDARD_DEVIATION 25.75 | 36.9 Units (IU) STANDARD_DEVIATION 25.65 | 37.3 Units (IU) STANDARD_DEVIATION 25.67 |
| Race/Ethnicity, Customized African | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 186 Participants | 186 Participants | 372 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Belgium | 2 participants | 5 participants | 7 participants |
| Region of Enrollment Czech Republic | 35 participants | 42 participants | 77 participants |
| Region of Enrollment Germany | 20 participants | 22 participants | 42 participants |
| Region of Enrollment Greece | 15 participants | 12 participants | 27 participants |
| Region of Enrollment Italy | 26 participants | 19 participants | 45 participants |
| Region of Enrollment Poland | 43 participants | 32 participants | 75 participants |
| Region of Enrollment Romania | 25 participants | 15 participants | 40 participants |
| Region of Enrollment Slovakia | 12 participants | 22 participants | 34 participants |
| Region of Enrollment Turkey | 7 participants | 8 participants | 15 participants |
| Region of Enrollment United Kingdom | 2 participants | 10 participants | 12 participants |
| Sex: Female, Male Female | 111 Participants | 101 Participants | 212 Participants |
| Sex: Female, Male Male | 76 Participants | 86 Participants | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 81 / 187 | 65 / 187 |
| serious Total, serious adverse events | 9 / 187 | 14 / 187 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.
Time frame: Baseline, Week 24
Population: Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glargine | Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24 | -1.28 Percent of Glycosylated Hemoglobin | Standard Error 0.08 |
| ILPS | Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24 | -1.18 Percent of Glycosylated Hemoglobin | Standard Error 0.09 |
95% CI: [-0.11, 0.31]ANCOVA
Secondary
7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.
Time frame: 24 weeks
Population: Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glargine | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Midday Pre-Meal | 8.19 millimoles per liter (mmol/L) | Standard Error 0.23 |
| Glargine | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Midday Postprandial | 9.11 millimoles per liter (mmol/L) | Standard Error 0.25 |
| Glargine | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Evening Pre-Meal | 8.80 millimoles per liter (mmol/L) | Standard Error 0.24 |
| Glargine | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Evening Postprandial | 9.27 millimoles per liter (mmol/L) | Standard Error 0.24 |
| Glargine | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | 0300 Hours | 8.16 millimoles per liter (mmol/L) | Standard Error 0.22 |
| Glargine | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Morning Pre-Meal | 8.26 millimoles per liter (mmol/L) | Standard Error 0.22 |
| Glargine | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Morning Postprandial | 8.93 millimoles per liter (mmol/L) | Standard Error 0.25 |
| ILPS | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Midday Pre-Meal | 7.90 millimoles per liter (mmol/L) | Standard Error 0.37 |
| ILPS | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | 0300 Hours | 8.30 millimoles per liter (mmol/L) | Standard Error 0.35 |
| ILPS | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Midday Postprandial | 9.58 millimoles per liter (mmol/L) | Standard Error 0.4 |
| ILPS | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Morning Postprandial | 9.19 millimoles per liter (mmol/L) | Standard Error 0.4 |
| ILPS | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Evening Pre-Meal | 8.75 millimoles per liter (mmol/L) | Standard Error 0.38 |
| ILPS | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Morning Pre-Meal | 8.63 millimoles per liter (mmol/L) | Standard Error 0.34 |
| ILPS | 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint | Evening Postprandial | 9.73 millimoles per liter (mmol/L) | Standard Error 0.37 |
95% CI: [-0.43, 1.17]Mixed Models Analysis
95% CI: [-0.66, 1.19]Mixed Models Analysis
95% CI: [-1.15, 0.57]Mixed Models Analysis
95% CI: [-0.46, 1.4]Mixed Models Analysis
95% CI: [-0.93, 0.83]Mixed Models Analysis
95% CI: [-0.41, 1.34]Mixed Models Analysis
95% CI: [-0.67, 0.96]Mixed Models Analysis
Secondary
Change From Baseline in HbA1c at Week 12 and Week 24
LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.
Time frame: Baseline, Week 12, Week 24
Population: Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Glargine | Change From Baseline in HbA1c at Week 12 and Week 24 | Week 12 Change (n=172, n=168) | -0.99 Percent of Glycosylated Hemoglobin |
| Glargine | Change From Baseline in HbA1c at Week 12 and Week 24 | Week 24 Change (n=170, n=166) | -1.29 Percent of Glycosylated Hemoglobin |
| ILPS | Change From Baseline in HbA1c at Week 12 and Week 24 | Week 12 Change (n=172, n=168) | -0.90 Percent of Glycosylated Hemoglobin |
| ILPS | Change From Baseline in HbA1c at Week 12 and Week 24 | Week 24 Change (n=170, n=166) | -1.07 Percent of Glycosylated Hemoglobin |
p-value: 0.458Mixed Models Analysis
p-value: 0.107Mixed Models Analysis
Secondary
Change in Body Weight From Baseline to Week 24
LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
Time frame: Baseline, Week 24
Population: Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glargine | Change in Body Weight From Baseline to Week 24 | 1.19 Kilograms (kg) | Standard Error 0.27 |
| ILPS | Change in Body Weight From Baseline to Week 24 | 1.03 Kilograms (kg) | Standard Error 0.3 |
95% CI: [-0.86, 0.55]ANCOVA
Secondary
Glycemic Variability at Endpoint
LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.
Time frame: Week 24
Population: Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glargine | Glycemic Variability at Endpoint | Fasting | 0.86 mmol/L | Standard Error 0.1 |
| Glargine | Glycemic Variability at Endpoint | Post-breakfast | 1.56 mmol/L | Standard Error 0.17 |
| Glargine | Glycemic Variability at Endpoint | Post-lunch | 1.61 mmol/L | Standard Error 0.15 |
| Glargine | Glycemic Variability at Endpoint | Post-dinner | 1.43 mmol/L | Standard Error 0.17 |
| ILPS | Glycemic Variability at Endpoint | Post-dinner | 1.40 mmol/L | Standard Error 0.17 |
| ILPS | Glycemic Variability at Endpoint | Fasting | 0.95 mmol/L | Standard Error 0.1 |
| ILPS | Glycemic Variability at Endpoint | Post-lunch | 1.51 mmol/L | Standard Error 0.16 |
| ILPS | Glycemic Variability at Endpoint | Post-breakfast | 1.64 mmol/L | Standard Error 0.18 |
p-value: 0.5568ANCOVA
p-value: 0.7523ANCOVA
p-value: 0.6448ANCOVA
p-value: 0.9122ANCOVA
Secondary
Number of Injections of Insulin at Week 24
Time frame: Week 24
Population: Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glargine | Number of Injections of Insulin at Week 24 | ≥4 per day | 4 Participants |
| Glargine | Number of Injections of Insulin at Week 24 | 3 to <4 per day | 129 Participants |
| Glargine | Number of Injections of Insulin at Week 24 | 2 to <3 per day | 8 Participants |
| ILPS | Number of Injections of Insulin at Week 24 | ≥4 per day | 1 Participants |
| ILPS | Number of Injections of Insulin at Week 24 | 3 to <4 per day | 102 Participants |
| ILPS | Number of Injections of Insulin at Week 24 | 2 to <3 per day | 10 Participants |
Secondary
Number of Participants With Adverse Events (AE)
A listing of adverse events is located in the Reported Adverse Event module.
Time frame: Baseline through Week 24
Population: Safety population - all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glargine | Number of Participants With Adverse Events (AE) | AEs | 81 participants |
| Glargine | Number of Participants With Adverse Events (AE) | Serious adverse events (SAE) | 9 participants |
| ILPS | Number of Participants With Adverse Events (AE) | AEs | 65 participants |
| ILPS | Number of Participants With Adverse Events (AE) | Serious adverse events (SAE) | 14 participants |
Secondary
Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint
Time frame: Week 24
Population: Full Analysis Set: All patients who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glargine | Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint | HbA1c < 7.0% | 50 Percent of Participants |
| Glargine | Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint | HbA1c <= 6.5% | 24 Percent of Participants |
| ILPS | Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint | HbA1c < 7.0% | 36 Percent of Participants |
| ILPS | Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint | HbA1c <= 6.5% | 14 Percent of Participants |
p-value: 0.1333Fisher Exact
p-value: 0.1213Fisher Exact
Secondary
Percentage of Participants With Self-Reported Hypoglycemic Episodes
Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
Time frame: Baseline through Week 24
Population: Safety population - all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glargine | Percentage of Participants With Self-Reported Hypoglycemic Episodes | >=1 hypoglycemic episode | 63.6 percentage of participants |
| Glargine | Percentage of Participants With Self-Reported Hypoglycemic Episodes | >=1 non-nocturnal hypoglycemic episode | 61.0 percentage of participants |
| Glargine | Percentage of Participants With Self-Reported Hypoglycemic Episodes | >=1 nocturnal hypoglycemic episode | 19.3 percentage of participants |
| Glargine | Percentage of Participants With Self-Reported Hypoglycemic Episodes | >=1 severe hypoglycemic episode | 0.5 percentage of participants |
| ILPS | Percentage of Participants With Self-Reported Hypoglycemic Episodes | >=1 nocturnal hypoglycemic episode | 25.7 percentage of participants |
| ILPS | Percentage of Participants With Self-Reported Hypoglycemic Episodes | >=1 hypoglycemic episode | 56.1 percentage of participants |
| ILPS | Percentage of Participants With Self-Reported Hypoglycemic Episodes | >=1 severe hypoglycemic episode | 1.6 percentage of participants |
| ILPS | Percentage of Participants With Self-Reported Hypoglycemic Episodes | >=1 non-nocturnal hypoglycemic episode | 54.0 percentage of participants |
p-value: 0.1701Fisher Exact
p-value: 0.1727Fisher Exact
p-value: 0.2094Fisher Exact
p-value: 0.623Fisher Exact
Secondary
Rate Of All Self-reported Hypoglycemic Episodes
Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
Time frame: Baseline through Week 24
Population: Safety population - all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Glargine | Rate Of All Self-reported Hypoglycemic Episodes | All reported episodes rate | 1.38 episode/30 days/participant | Standard Error 0.21 |
| Glargine | Rate Of All Self-reported Hypoglycemic Episodes | Non-Nocturnal reported episodes rate | 1.16 episode/30 days/participant | Standard Error 0.2 |
| Glargine | Rate Of All Self-reported Hypoglycemic Episodes | Documented <=3.0 mmol/L rate | 0.13 episode/30 days/participant | Standard Error 0.04 |
| Glargine | Rate Of All Self-reported Hypoglycemic Episodes | Severe reported episodes rate | 0 episode/30 days/participant | Standard Error 0.013 |
| Glargine | Rate Of All Self-reported Hypoglycemic Episodes | Nocturnal reported episodes rate | 0.19 episode/30 days/participant | Standard Error 0.05 |
| Glargine | Rate Of All Self-reported Hypoglycemic Episodes | Documented <=3.9 millimoles per liter(mmol/L) rate | 0.89 episode/30 days/participant | Standard Error 0.15 |
| ILPS | Rate Of All Self-reported Hypoglycemic Episodes | Nocturnal reported episodes rate | 0.15 episode/30 days/participant | Standard Error 0.06 |
| ILPS | Rate Of All Self-reported Hypoglycemic Episodes | Documented <=3.0 mmol/L rate | 0.12 episode/30 days/participant | Standard Error 0.05 |
| ILPS | Rate Of All Self-reported Hypoglycemic Episodes | All reported episodes rate | 0.84 episode/30 days/participant | Standard Error 0.26 |
| ILPS | Rate Of All Self-reported Hypoglycemic Episodes | Documented <=3.9 millimoles per liter(mmol/L) rate | 0.49 episode/30 days/participant | Standard Error 0.18 |
| ILPS | Rate Of All Self-reported Hypoglycemic Episodes | Non-Nocturnal reported episodes rate | 0.71 episode/30 days/participant | Standard Error 0.24 |
| ILPS | Rate Of All Self-reported Hypoglycemic Episodes | Severe reported episodes rate | 0 episode/30 days/participant | Standard Error 0.029 |
95% CI: [-1.19, 0.12]Mixed Models Analysis
95% CI: [-0.2, 0.11]Mixed Models Analysis
95% CI: [-1.06, 0.16]Mixed Models Analysis
95% CI: [-0.86, 0.06]Mixed Models Analysis
95% CI: [-0.14, 0.12]Mixed Models Analysis
Secondary
Total Daily Insulin Dose at Endpoint
LSMean values presented were controlled for treatment, country, and baseline HbA1C value.
Time frame: Week 24
Population: Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Glargine | Total Daily Insulin Dose at Endpoint | 78.05 Units | Standard Error 3.15 |
| ILPS | Total Daily Insulin Dose at Endpoint | 80.23 Units | Standard Error 4.31 |
95% CI: [-8.33, 12.68]Mixed Models Analysis