Diabetes Mellitus, Type 2
Conditions
Keywords
diabetes, type 2
Brief summary
This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled. This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications. The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.
Interventions
DRUGInsulin glargine
Subcutaneous injection daily
DRUGLispro Low Mix
Subcutaneous injection twice daily.
DRUGLispro Mid Mix
Lispro Mid Mix subcutaneous injection 3 times daily.
DRUGLispro
Lispro subcutaneous injection 3 times daily.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Must have type 2 diabetes. * Must be at least 30 and less than 80 years of age at the time of Visit 1. * Must be on at least two oral antidiabetes medications for at least 90 days. * Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.
Exclusion criteria
* Must not have used insulin on a regular basis in the last 12 months. * Must not have had more than one episode of severe hypoglycemia in the last 24 weeks. * Must not have a body mass index (BMI) of greater than 45 (morbid obesity). * Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease. * Must not be pregnant or intend to get pregnant during course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c) | Endpoint (Initiation: Week 24) | — |
| MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix) | Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years) | HbA1c goal: HbA1c ≤7.0% or HbA1c \>7.0% but increased \<0.4% from last HbA1c ≤7.0% |
| ADDENDUM: 24-Week Endpoint HbA1c | Endpoint (Addendum) (24 weeks: Week 48) | HbA1c at 24-week endpoint in Intensification Addendum of the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| INITIATION: HbA1c | Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF) | — |
| INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Endpoint (LOCF) (Initiation: Week 24) | Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose. |
| INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG) | Baseline (Initiation), Endpoint (Week 24) | — |
| INITIATION: Incremental Change From Baseline in Body Weight | Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF) | — |
| INITIATION: Body Weight | Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF) | — |
| INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]). | Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. |
| INITIATION: Rate of Self-reported Hypoglycemic Episodes | Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0]) | Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. |
| INITIATION: Insulin Dose | Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF) | — |
| INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age | Endpoint (Initiation: Week 24) | Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). |
| INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | Endpoint (Initiation: Week 24) | Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). |
| INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Endpoint (Initiation: Week 24) | Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) \* fasting plasma glucose (millimoles per liter) / 22.5. |
| INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c | Endpoint (Initiation: Week 24) | Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). |
| INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group | Endpoint (Initiation: Week 24) | Comparison of baseline HbA1c percentage group (\<8.5,\>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). |
| INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG | Endpoint (Initiation: Week 24) | Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). |
| INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose | Endpoint (Initiation: Week 24) | Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). |
| INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline | Endpoint (Initiation: Week 24) | Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). |
| MAINTENANCE: HbA1c at Specified Visits and Endpoint | Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years) | — |
| MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years) | Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose. |
| MAINTENANCE: Rate of Increase in HbA1c | Endpoint (LOCF) (Maintenance: up to 2.5 years) | Rate of increase: HbA1c change/time period (month). |
| MAINTENANCE: Incremental Change From Baseline in Body Weight | Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years) | — |
| MAINTENANCE: Body Weight | Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years) | — |
| MAINTENANCE: Insulin Dose | Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years) | — |
| MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0) | Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. |
| MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0]) | Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. |
| MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol | Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years) | — |
| MAINTENANCE: Change From Baseline to Endpoint in HbA1c | Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years) | — |
| MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of duration of diabetes group (\<10, 10-\<20, \>=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of duration of diabetes group (\<10, 10-\<20, \>=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of baseline HbA1c group (\<8.5,\>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of baseline HbA1c group (\<8.5,\>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Endpoint (LOCF) (Maintenance) (up to 2.5 years) | Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%. |
| ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint | Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48]) | — |
| ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | Endpoint (Addendum: 24 weeks [Week 48]) | — |
| ADDENDUM: 7-point SMPG Profiles | Endpoint (Addendum: 24 weeks [Week 48]) | Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose. |
| ADDENDUM: Incremental Change From Baseline in Body Weight | Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF) | — |
| ADDENDUM: Body Weight | Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF) | — |
| MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5% | Endpoint (LOCF) (Maintenance: up to 2.5 years) | — |
| ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF) | Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. |
| ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase | Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia. |
| ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48) | — |
| ADDENDUM: HbA1c at Specified Visits and Endpoint | Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48) | — |
| ADDENDUM: Insulin Dose | Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF) | — |
| INITIATION: Change in HbA1c From Baseline to 24 Weeks | Baseline (Initiation) to Endpoint (LOCF, Week 24) | — |
| INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint | Endpoint (Initiation: Week 24) | — |
Countries
Argentina, Australia, Brazil, Canada, Greece, Hungary, India, Netherlands, Puerto Rico, Romania, Spain, United States
Participant flow
Pre-assignment details
Initiation: Glargine or Lispro LM - 24 weeks. Maintenance: Up to 2 more years treatment if HbA1c \<=7.0 at 24 weeks. After Initiation, if HbA1c \>7.0 after 24 weeks, instead of entering Maintenance, those from Lispro LM could receive Basal bolus or Mid Mix; glargine could receive Basal bolus or Lispro LM for 24 weeks in Intensification Addendum.
Participants by arm
| Arm | Count |
|---|---|
| Insulin Glargine Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks. | 1,046 |
| Lispro LM Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks. | 1,045 |
| Total | 2,091 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Initiation | Adverse Event | 6 | 15 | 0 | 0 | 0 | 0 |
| Initiation | Death | 1 | 5 | 0 | 0 | 0 | 0 |
| Initiation | Discontinuation Oral Antihyperglycemics | 0 | 1 | 0 | 0 | 0 | 0 |
| Initiation | Entry Criteria Exclusion | 7 | 9 | 0 | 0 | 0 | 0 |
| Initiation | Lost to Follow-up | 42 | 41 | 0 | 0 | 0 | 0 |
| Initiation | Physician Decision | 15 | 18 | 0 | 0 | 0 | 0 |
| Initiation | Protocol Violation | 9 | 10 | 0 | 0 | 0 | 0 |
| Initiation | Sponsor Decision | 13 | 5 | 0 | 0 | 0 | 0 |
| Initiation | Withdrawal by Subject | 35 | 41 | 0 | 0 | 0 | 0 |
| Intensification Addendum | Adverse Event | 0 | 0 | 0 | 4 | 1 | 3 |
| Intensification Addendum | Death | 0 | 0 | 0 | 0 | 1 | 0 |
| Intensification Addendum | Entry Criteria Exclusion | 0 | 0 | 1 | 0 | 0 | 0 |
| Intensification Addendum | Lack of Efficacy | 0 | 0 | 0 | 1 | 1 | 0 |
| Intensification Addendum | Lost to Follow-up | 0 | 0 | 4 | 6 | 7 | 7 |
| Intensification Addendum | Physician Decision | 0 | 0 | 4 | 1 | 3 | 2 |
| Intensification Addendum | Protocol Violation | 0 | 0 | 2 | 2 | 6 | 6 |
| Intensification Addendum | Sponsor Decision | 0 | 0 | 0 | 0 | 1 | 1 |
| Intensification Addendum | Withdrawal by Subject | 0 | 0 | 12 | 14 | 9 | 18 |
| Maintenance | Adverse Event | 4 | 4 | 0 | 0 | 0 | 0 |
| Maintenance | Death | 4 | 4 | 0 | 0 | 0 | 0 |
| Maintenance | Discontinuation Antihyperglycemic Drugs | 3 | 2 | 0 | 0 | 0 | 0 |
| Maintenance | Entry Criteria Exclusion | 1 | 4 | 0 | 0 | 0 | 0 |
| Maintenance | HbA1c>7.5% | 123 | 126 | 0 | 0 | 0 | 0 |
| Maintenance | Lack of Efficacy | 32 | 30 | 0 | 0 | 0 | 0 |
| Maintenance | Lost to Follow-up | 17 | 13 | 0 | 0 | 0 | 0 |
| Maintenance | Physician Decision | 9 | 9 | 0 | 0 | 0 | 0 |
| Maintenance | Protocol Violation | 16 | 24 | 0 | 0 | 0 | 0 |
| Maintenance | Sponsor Decision | 4 | 0 | 0 | 0 | 0 | 0 |
| Maintenance | Withdrawal by Subject | 18 | 18 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Insulin Glargine | Total | Lispro LM |
|---|---|---|---|
| 1,5 Anhydroglucitol (1,5 AG) | 4.97 micrograms per milliliter (ug/mL) STANDARD_DEVIATION 4.06 | 4.99 micrograms per milliliter (ug/mL) STANDARD_DEVIATION 4.09 | 5.02 micrograms per milliliter (ug/mL) STANDARD_DEVIATION 4.12 |
| Age Continuous | 56.59 years STANDARD_DEVIATION 9.95 | 56.82 years STANDARD_DEVIATION 9.84 | 57.05 years STANDARD_DEVIATION 9.73 |
| Average of All Blood Glucose | 218.05 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 56.55 | 217.08 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 55.48 | 216.12 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 54.4 |
| Body Mass Index (BMI) | 31.69 kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 6.01 | 31.68 kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 5.98 | 31.67 kilograms per meters squared (kg/m^2) STANDARD_DEVIATION 5.96 |
| Duration of Diabetes | 9.30 years STANDARD_DEVIATION 5.93 | 9.51 years STANDARD_DEVIATION 6.11 | 9.73 years STANDARD_DEVIATION 6.29 |
| Fasting Blood Glucose | 196.16 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 55.14 | 194.53 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 54.2 | 192.91 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 53.22 |
| Glycosylated Hemoglobin (HbA1c) | 9.02 percent glycosylated hemoglobin STANDARD_DEVIATION 1.24 | 9.04 percent glycosylated hemoglobin STANDARD_DEVIATION 1.26 | 9.06 percent glycosylated hemoglobin STANDARD_DEVIATION 1.29 |
| Mean of Post Meals Blood Glucose (Postprandial) | 241.58 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 61.06 | 240.82 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 59.61 | 240.08 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 58.15 |
| Mean of Pre-Meals Blood Glucose | 201.29 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 57.4 | 200.13 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 56.14 | 198.97 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 54.87 |
| Race/Ethnicity, Customized African Descent | 70 participants | 132 participants | 62 participants |
| Race/Ethnicity, Customized Caucasian | 668 participants | 1319 participants | 651 participants |
| Race/Ethnicity, Customized East/Southeast Asian | 27 participants | 45 participants | 18 participants |
| Race/Ethnicity, Customized Hispanic | 116 participants | 252 participants | 136 participants |
| Race/Ethnicity, Customized Other | 29 participants | 68 participants | 39 participants |
| Race/Ethnicity, Customized Western Asian | 136 participants | 275 participants | 139 participants |
| Region of Enrollment Argentina | 98 participants | 193 participants | 95 participants |
| Region of Enrollment Australia | 48 participants | 96 participants | 48 participants |
| Region of Enrollment Brazil | 45 participants | 91 participants | 46 participants |
| Region of Enrollment Canada | 60 participants | 120 participants | 60 participants |
| Region of Enrollment Greece | 25 participants | 50 participants | 25 participants |
| Region of Enrollment Hungary | 24 participants | 50 participants | 26 participants |
| Region of Enrollment India | 131 participants | 259 participants | 128 participants |
| Region of Enrollment Netherlands | 30 participants | 57 participants | 27 participants |
| Region of Enrollment Romania | 29 participants | 57 participants | 28 participants |
| Region of Enrollment Spain | 47 participants | 96 participants | 49 participants |
| Region of Enrollment United States | 509 participants | 1022 participants | 513 participants |
| Sex: Female, Male Female | 494 Participants | 987 Participants | 493 Participants |
| Sex: Female, Male Male | 552 Participants | 1104 Participants | 552 Participants |
| Weight | 88.23 kilograms (kg) STANDARD_DEVIATION 20.78 | 88.53 kilograms (kg) STANDARD_DEVIATION 20.87 | 88.84 kilograms (kg) STANDARD_DEVIATION 20.97 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 785 / 1,024 | 826 / 1,026 | 96 / 171 | 111 / 198 | 88 / 164 | 92 / 192 | 394 / 419 | 463 / 473 |
| serious Total, serious adverse events | 45 / 1,046 | 65 / 1,045 | 5 / 174 | 10 / 200 | 9 / 171 | 11 / 199 | 48 / 419 | 48 / 473 |
Outcome results
Primary
ADDENDUM: 24-Week Endpoint HbA1c
HbA1c at 24-week endpoint in Intensification Addendum of the trial.
Time frame: Endpoint (Addendum) (24 weeks: Week 48)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: Week 24: 48 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | ADDENDUM: 24-Week Endpoint HbA1c | 8.19 percent glycosylated hemoglobin | Standard Deviation 1.26 |
| Lispro Low Mix | ADDENDUM: 24-Week Endpoint HbA1c | 8.03 percent glycosylated hemoglobin | Standard Deviation 1.15 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 24-Week Endpoint HbA1c | 8.16 percent glycosylated hemoglobin | Standard Deviation 1.43 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 24-Week Endpoint HbA1c | 8.14 percent glycosylated hemoglobin | Standard Deviation 1.53 |
p-value: 0.271ANCOVA
p-value: 0.99ANCOVA
Primary
INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)
Time frame: Endpoint (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment in the initiation phase. Initiation baseline: Week 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c) | 7.33 percent glycosylated hemoglobin | Standard Deviation 1.07 |
| Lispro Low Mix | INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c) | 7.23 percent glycosylated hemoglobin | Standard Deviation 1.08 |
p-value: 0.005ANCOVA
Primary
MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)
HbA1c goal: HbA1c ≤7.0% or HbA1c \>7.0% but increased \<0.4% from last HbA1c ≤7.0%
Time frame: Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)
Population: Last observation carried forward method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Insulin Glargine | MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix) | 14.40 months |
| Lispro Low Mix | MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix) | 16.80 months |
p-value: 0.04Log Rank
Secondary
ADDENDUM: 7-point SMPG Profiles
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Time frame: Endpoint (Addendum: 24 weeks [Week 48])
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Mean all BG values (n=135,150,161,178) | 156.41 mg/dL | Standard Deviation 33.04 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Mean all 2-hour PP BG (n=135,150,161,178) | 168.55 mg/dL | Standard Deviation 38.92 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Midday 2-hour (hr) PP BG (n=135,149,160,176)) | 165.24 mg/dL | Standard Deviation 46.46 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Mean AM/PM 2hr BG excursion (n=135,150,161,178) | 20.74 mg/dL | Standard Deviation 30.4 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Mean all premeal blood glucose (n=135,150,161,178) | 147.68 mg/dL | Standard Deviation 32.85 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Mean fast blood glucose (BG) (n=135,150,161,178) | 145.33 mg/dL | Standard Deviation 35.23 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Mean combined AM/PM 2hr PP BG (n=135,150,161,178) | 170.04 mg/dL | Standard Deviation 39.98 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | AM 2-hour postprandial (PP) BG (n=135,149,160,176) | 168.71 mg/dL | Standard Deviation 44.9 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Baseline average of all BG (n=152,161,183,187) | 164.02 mg/dL | Standard Deviation 39.2 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | PM premeal blood glucose (n=135,150,161,178) | 153.62 mg/dL | Standard Deviation 41.82 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | PM 2-hour postprandial BG (n=134,150,161,178) | 171.51 mg/dL | Standard Deviation 44.42 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Baseline mean of postmeal BG (n=152,161,182,187) | 183.82 mg/dL | Standard Deviation 45.13 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | 3 AM blood glucose (n=132,146,153,171) | 146.50 mg/dL | Standard Deviation 40.09 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Baseline fasting glucose (n=152,161,183,187) | 147.93 mg/dL | Standard Deviation 39.46 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | AM 2-hour BG excursion (n=135,149,160,176) | 23.30 mg/dL | Standard Deviation 39.14 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Midday premeal blood glucose (n=135,150,161,177) | 144.08 mg/dL | Standard Deviation 43.93 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Baseline mean all premeals BG (n=152,161,183,187) | 149.91 mg/dL | Standard Deviation 38.96 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Midday 2-hour BG excursion (n=135,148,160,176) | 20.71 mg/dL | Standard Deviation 43.35 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | PM 2-hour BG excursion (n=134,150,161,178) | 17.88 mg/dL | Standard Deviation 38.16 |
| Insulin Glargine | ADDENDUM: 7-point SMPG Profiles | Mean all mealtime excursions (n=135,150,161,178) | 20.61 mg/dL | Standard Deviation 28.41 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Mean all BG values (n=135,150,161,178) | 157.52 mg/dL | Standard Deviation 32.67 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Mean all mealtime excursions (n=135,150,161,178) | 19.64 mg/dL | Standard Deviation 27.87 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Baseline average of all BG (n=152,161,183,187) | 162.18 mg/dL | Standard Deviation 35.22 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Mean AM/PM 2hr BG excursion (n=135,150,161,178) | 20.06 mg/dL | Standard Deviation 34.62 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | PM 2-hour postprandial BG (n=134,150,161,178) | 172.98 mg/dL | Standard Deviation 48.01 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Mean all 2-hour PP BG (n=135,150,161,178) | 169.14 mg/dL | Standard Deviation 39.27 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Mean fast blood glucose (BG) (n=135,150,161,178) | 151.15 mg/dL | Standard Deviation 37.31 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Baseline fasting glucose (n=152,161,183,187) | 143.99 mg/dL | Standard Deviation 34.91 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | PM 2-hour BG excursion (n=134,150,161,178) | 21.14 mg/dL | Standard Deviation 42.48 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Mean all premeal blood glucose (n=135,150,161,178) | 149.67 mg/dL | Standard Deviation 33.2 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | 3 AM blood glucose (n=132,146,153,171) | 146.30 mg/dL | Standard Deviation 41.36 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Mean combined AM/PM 2hr PP BG (n=135,150,161,178) | 171.65 mg/dL | Standard Deviation 43.23 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Midday 2-hour BG excursion (n=135,148,160,176) | 18.97 mg/dL | Standard Deviation 41.4 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Midday 2-hour (hr) PP BG (n=135,149,160,176)) | 164.13 mg/dL | Standard Deviation 42.17 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Baseline mean all premeals BG (n=152,161,183,187) | 149.50 mg/dL | Standard Deviation 34.82 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Midday premeal blood glucose (n=135,150,161,177) | 145.89 mg/dL | Standard Deviation 42.61 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | AM 2-hour BG excursion (n=135,149,160,176) | 18.97 mg/dL | Standard Deviation 46.88 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | PM premeal blood glucose (n=135,150,161,178) | 151.96 mg/dL | Standard Deviation 41.66 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | AM 2-hour postprandial (PP) BG (n=135,149,160,176) | 170.36 mg/dL | Standard Deviation 50.25 |
| Lispro Low Mix | ADDENDUM: 7-point SMPG Profiles | Baseline mean of postmeal BG (n=152,161,182,187) | 181.18 mg/dL | Standard Deviation 43.49 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Mean all premeal blood glucose (n=135,150,161,178) | 149.04 mg/dL | Standard Deviation 38.35 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Mean fast blood glucose (BG) (n=135,150,161,178) | 126.22 mg/dL | Standard Deviation 39 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | AM 2-hour postprandial (PP) BG (n=135,149,160,176) | 170.14 mg/dL | Standard Deviation 49.27 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Midday premeal blood glucose (n=135,150,161,177) | 144.61 mg/dL | Standard Deviation 41.39 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Midday 2-hour (hr) PP BG (n=135,149,160,176)) | 167.45 mg/dL | Standard Deviation 48.27 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | PM premeal blood glucose (n=135,150,161,178) | 157.15 mg/dL | Standard Deviation 54.22 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | PM 2-hour postprandial BG (n=134,150,161,178) | 175.34 mg/dL | Standard Deviation 53.17 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | 3 AM blood glucose (n=132,146,153,171) | 147.14 mg/dL | Standard Deviation 39.99 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | AM 2-hour BG excursion (n=135,149,160,176) | 24.35 mg/dL | Standard Deviation 38.44 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Midday 2-hour BG excursion (n=135,148,160,176) | 23.30 mg/dL | Standard Deviation 37.21 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | PM 2-hour BG excursion (n=134,150,161,178) | 18.58 mg/dL | Standard Deviation 41.86 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Mean all mealtime excursions (n=135,150,161,178) | 21.82 mg/dL | Standard Deviation 26.09 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Mean all 2-hour PP BG (n=135,150,161,178) | 170.95 mg/dL | Standard Deviation 42.89 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Mean combined AM/PM 2hr PP BG (n=135,150,161,178) | 172.73 mg/dL | Standard Deviation 45.15 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Mean AM/PM 2hr BG excursion (n=135,150,161,178) | 21.42 mg/dL | Standard Deviation 32.09 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Mean all BG values (n=135,150,161,178) | 158.33 mg/dL | Standard Deviation 37.89 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Baseline mean all premeals BG (n=152,161,183,187) | 146.64 mg/dL | Standard Deviation 39.89 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Baseline mean of postmeal BG (n=152,161,182,187) | 186.19 mg/dL | Standard Deviation 46.23 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Baseline average of all BG (n=152,161,183,187) | 163.19 mg/dL | Standard Deviation 40.08 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: 7-point SMPG Profiles | Baseline fasting glucose (n=152,161,183,187) | 131.54 mg/dL | Standard Deviation 42.16 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | PM 2-hour BG excursion (n=134,150,161,178) | 21.59 mg/dL | Standard Deviation 43.88 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Midday 2-hour BG excursion (n=135,148,160,176) | 39.40 mg/dL | Standard Deviation 46.21 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Baseline average of all BG (n=152,161,183,187) | 163.20 mg/dL | Standard Deviation 34.69 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Mean all BG values (n=135,150,161,178) | 157.41 mg/dL | Standard Deviation 33.21 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | AM 2-hour BG excursion (n=135,149,160,176) | 31.33 mg/dL | Standard Deviation 43.27 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | 3 AM blood glucose (n=132,146,153,171) | 139.86 mg/dL | Standard Deviation 39.15 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | AM 2-hour postprandial (PP) BG (n=135,149,160,176) | 171.40 mg/dL | Standard Deviation 46.9 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Baseline mean all premeals BG (n=152,161,183,187) | 146.01 mg/dL | Standard Deviation 34.8 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | PM 2-hour postprandial BG (n=134,150,161,178) | 174.94 mg/dL | Standard Deviation 46.73 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | PM premeal blood glucose (n=135,150,161,178) | 153.19 mg/dL | Standard Deviation 40.74 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Mean fast blood glucose (BG) (n=135,150,161,178) | 139.45 mg/dL | Standard Deviation 34.92 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Baseline mean of postmeal BG (n=152,161,182,187) | 185.62 mg/dL | Standard Deviation 41.67 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Midday 2-hour (hr) PP BG (n=135,149,160,176)) | 181.46 mg/dL | Standard Deviation 53.34 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Mean all premeal blood glucose (n=135,150,161,178) | 144.85 mg/dL | Standard Deviation 32.07 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Midday premeal blood glucose (n=135,150,161,177) | 141.87 mg/dL | Standard Deviation 43.33 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Mean combined AM/PM 2hr PP BG (n=135,150,161,178) | 172.88 mg/dL | Standard Deviation 41.56 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Mean all 2-hour PP BG (n=135,150,161,178) | 175.61 mg/dL | Standard Deviation 42.15 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Mean all mealtime excursions (n=135,150,161,178) | 30.38 mg/dL | Standard Deviation 31.11 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Baseline fasting glucose (n=152,161,183,187) | 131.02 mg/dL | Standard Deviation 34.91 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: 7-point SMPG Profiles | Mean AM/PM 2hr BG excursion (n=135,150,161,178) | 26.45 mg/dL | Standard Deviation 33.36 |
p-value: 0.241ANCOVA
p-value: 0.305ANCOVA
p-value: 0.842ANCOVA
p-value: 0.917ANCOVA
p-value: 0.648ANCOVA
p-value: 0.613ANCOVA
p-value: 0.813ANCOVA
p-value: 0.953ANCOVA
p-value: 0.933ANCOVA
p-value: 0.348ANCOVA
p-value: 0.625ANCOVA
p-value: 0.573ANCOVA
p-value: 0.711ANCOVA
p-value: 0.372ANCOVA
p-value: 0.516ANCOVA
p-value: 0.639ANCOVA
p-value: 0.131ANCOVA
p-value: 0.53ANCOVA
p-value: 0.578ANCOVA
p-value: 0.004ANCOVA
p-value: 0.951ANCOVA
p-value: 0.58ANCOVA
p-value: 0.071ANCOVA
p-value: 0.081ANCOVA
p-value: <0.001ANCOVA
p-value: 0.542ANCOVA
p-value: 0.003ANCOVA
p-value: 0.105ANCOVA
p-value: 0.487ANCOVA
p-value: 0.491ANCOVA
p-value: 0.127ANCOVA
p-value: 0.861ANCOVA
Secondary
ADDENDUM: Body Weight
Time frame: Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | ADDENDUM: Body Weight | Week 24 (n=145,151,164,176) | 91.92 kilograms | Standard Deviation 23.32 |
| Insulin Glargine | ADDENDUM: Body Weight | Week 6 (n=162,163,184,193) | 91.53 kilograms | Standard Deviation 23.33 |
| Insulin Glargine | ADDENDUM: Body Weight | Endpoint (n=164,170,192,198) | 92.40 kilograms | Standard Deviation 23.67 |
| Insulin Glargine | ADDENDUM: Body Weight | Week 12 (n=151,158,174,187) | 91.59 kilograms | Standard Deviation 22.88 |
| Insulin Glargine | ADDENDUM: Body Weight | Baseline (n=170,173,198,200) | 91.85 kilograms | Standard Deviation 23.41 |
| Lispro Low Mix | ADDENDUM: Body Weight | Week 12 (n=151,158,174,187) | 94.60 kilograms | Standard Deviation 25.08 |
| Lispro Low Mix | ADDENDUM: Body Weight | Week 24 (n=145,151,164,176) | 94.18 kilograms | Standard Deviation 24.99 |
| Lispro Low Mix | ADDENDUM: Body Weight | Endpoint (n=164,170,192,198) | 94.09 kilograms | Standard Deviation 24.65 |
| Lispro Low Mix | ADDENDUM: Body Weight | Week 6 (n=162,163,184,193) | 93.71 kilograms | Standard Deviation 24.82 |
| Lispro Low Mix | ADDENDUM: Body Weight | Baseline (n=170,173,198,200) | 93.63 kilograms | Standard Deviation 24.21 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Body Weight | Week 12 (n=151,158,174,187) | 89.62 kilograms | Standard Deviation 22.04 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Body Weight | Baseline (n=170,173,198,200) | 89.25 kilograms | Standard Deviation 21.62 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Body Weight | Week 6 (n=162,163,184,193) | 89.66 kilograms | Standard Deviation 21.97 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Body Weight | Week 24 (n=145,151,164,176) | 89.80 kilograms | Standard Deviation 21.95 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Body Weight | Endpoint (n=164,170,192,198) | 90.09 kilograms | Standard Deviation 21.95 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Body Weight | Week 24 (n=145,151,164,176) | 91.22 kilograms | Standard Deviation 23.3 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Body Weight | Week 6 (n=162,163,184,193) | 89.85 kilograms | Standard Deviation 22.5 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Body Weight | Baseline (n=170,173,198,200) | 90.09 kilograms | Standard Deviation 23.45 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Body Weight | Week 12 (n=151,158,174,187) | 91.19 kilograms | Standard Deviation 23.68 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Body Weight | Endpoint (n=164,170,192,198) | 91.45 kilograms | Standard Deviation 23.64 |
p-value: 0.467ANOVA
p-value: 0.575ANCOVA
p-value: 0.726ANCOVA
p-value: 0.978ANCOVA
p-value: 0.345ANCOVA
p-value: 0.745ANOVA
p-value: 0.166ANCOVA
p-value: 0.064ANCOVA
p-value: 0.199ANCOVA
p-value: 0.098ANCOVA
Secondary
ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
Time frame: Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Baseline (n=166,172,197,199) | 7.84 ug/mL | Standard Deviation 5.27 |
| Insulin Glargine | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Change (n=142,150,165,171) | 0.26 ug/mL | Standard Deviation 4.4 |
| Insulin Glargine | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Endpoint (n=142,150,165,171) | 8.18 ug/mL | Standard Deviation 6.27 |
| Lispro Low Mix | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Baseline (n=166,172,197,199) | 7.77 ug/mL | Standard Deviation 5.01 |
| Lispro Low Mix | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Change (n=142,150,165,171) | -0.18 ug/mL | Standard Deviation 4.91 |
| Lispro Low Mix | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Endpoint (n=142,150,165,171) | 7.73 ug/mL | Standard Deviation 5.74 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Endpoint (n=142,150,165,171) | 8.43 ug/mL | Standard Deviation 6.17 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Baseline (n=166,172,197,199) | 7.31 ug/mL | Standard Deviation 4.99 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Change (n=142,150,165,171) | 0.90 ug/mL | Standard Deviation 4.31 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Baseline (n=166,172,197,199) | 7.37 ug/mL | Standard Deviation 5.07 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Change (n=142,150,165,171) | 0.53 ug/mL | Standard Deviation 4.53 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24 | Endpoint (n=142,150,165,171) | 8.14 ug/mL | Standard Deviation 5.21 |
p-value: 0.917ANOVA
p-value: 0.754ANOVA
p-value: 0.42ANCOVA
p-value: 0.514ANCOVA
Secondary
ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint
Time frame: Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint | Endpoint (n=160,187,159,176) | 0.19 percent | Standard Deviation 1.12 |
| Insulin Glargine | ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint | Baseline (n=174,200,171,199) | 8.01 percent | Standard Deviation 0.93 |
| Lispro Low Mix | ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint | Endpoint (n=160,187,159,176) | 0.04 percent | Standard Deviation 1.06 |
| Lispro Low Mix | ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint | Baseline (n=174,200,171,199) | 8.03 percent | Standard Deviation 0.95 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint | Baseline (n=174,200,171,199) | 8.00 percent | Standard Deviation 0.92 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint | Endpoint (n=160,187,159,176) | 0.19 percent | Standard Deviation 1.16 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint | Endpoint (n=160,187,159,176) | 0.18 percent | Standard Deviation 1.26 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint | Baseline (n=174,200,171,199) | 7.98 percent | Standard Deviation 0.95 |
p-value: 0.552ANOVA
p-value: 0.271ANCOVA
p-value: 0.77ANOVA
p-value: 0.99ANCOVA
Secondary
ADDENDUM: HbA1c at Specified Visits and Endpoint
Time frame: Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | ADDENDUM: HbA1c at Specified Visits and Endpoint | Baseline (n=174,200,171,199) | 8.01 percent glycosylated hemoglobin | Standard Deviation 0.93 |
| Insulin Glargine | ADDENDUM: HbA1c at Specified Visits and Endpoint | Week 12 (n=150,175,151,161) | 8.11 percent glycosylated hemoglobin | Standard Deviation 1.06 |
| Insulin Glargine | ADDENDUM: HbA1c at Specified Visits and Endpoint | Week 24 (n=145,171,144,159) | 8.19 percent glycosylated hemoglobin | Standard Deviation 1.27 |
| Insulin Glargine | ADDENDUM: HbA1c at Specified Visits and Endpoint | Endpoint (n=160, 187,159,176) | 8.19 percent glycosylated hemoglobin | Standard Deviation 1.26 |
| Lispro Low Mix | ADDENDUM: HbA1c at Specified Visits and Endpoint | Week 12 (n=150,175,151,161) | 8.07 percent glycosylated hemoglobin | Standard Deviation 1.2 |
| Lispro Low Mix | ADDENDUM: HbA1c at Specified Visits and Endpoint | Week 24 (n=145,171,144,159) | 8.05 percent glycosylated hemoglobin | Standard Deviation 1.18 |
| Lispro Low Mix | ADDENDUM: HbA1c at Specified Visits and Endpoint | Endpoint (n=160, 187,159,176) | 8.03 percent glycosylated hemoglobin | Standard Deviation 1.15 |
| Lispro Low Mix | ADDENDUM: HbA1c at Specified Visits and Endpoint | Baseline (n=174,200,171,199) | 8.03 percent glycosylated hemoglobin | Standard Deviation 0.95 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: HbA1c at Specified Visits and Endpoint | Week 24 (n=145,171,144,159) | 8.19 percent glycosylated hemoglobin | Standard Deviation 1.47 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: HbA1c at Specified Visits and Endpoint | Week 12 (n=150,175,151,161) | 8.13 percent glycosylated hemoglobin | Standard Deviation 1.26 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: HbA1c at Specified Visits and Endpoint | Endpoint (n=160, 187,159,176) | 8.16 percent glycosylated hemoglobin | Standard Deviation 1.43 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: HbA1c at Specified Visits and Endpoint | Baseline (n=174,200,171,199) | 8.00 percent glycosylated hemoglobin | Standard Deviation 0.92 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: HbA1c at Specified Visits and Endpoint | Endpoint (n=160, 187,159,176) | 8.14 percent glycosylated hemoglobin | Standard Deviation 1.53 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: HbA1c at Specified Visits and Endpoint | Week 12 (n=150,175,151,161) | 8.19 percent glycosylated hemoglobin | Standard Deviation 1.38 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: HbA1c at Specified Visits and Endpoint | Baseline (n=174,200,171,199) | 7.98 percent glycosylated hemoglobin | Standard Deviation 0.95 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: HbA1c at Specified Visits and Endpoint | Week 24 (n=145,171,144,159) | 8.14 percent glycosylated hemoglobin | Standard Deviation 1.55 |
p-value: 0.77ANOVA
p-value: 0.566ANCOVA
p-value: 0.812ANCOVA
p-value: 0.99ANCOVA
p-value: 0.552ANOVA
p-value: 0.179ANCOVA
p-value: 0.377ANCOVA
p-value: 0.271ANCOVA
Secondary
ADDENDUM: Incremental Change From Baseline in Body Weight
Time frame: Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 24 change (n=144,151,163,176) | 0.77 kilograms | Standard Deviation 3.01 |
| Insulin Glargine | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 6 change (n=161,162,183,193) | 0.38 kilograms | Standard Deviation 2.78 |
| Insulin Glargine | ADDENDUM: Incremental Change From Baseline in Body Weight | Endpoint change (n=163,169,191,198) | 0.85 kilograms | Standard Deviation 3.46 |
| Insulin Glargine | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 12 change (n=150,158,173,187) | 0.43 kilograms | Standard Deviation 2.61 |
| Insulin Glargine | ADDENDUM: Incremental Change From Baseline in Body Weight | Baseline (n=170,173,198,200) | 91.85 kilograms | Standard Deviation 23.41 |
| Lispro Low Mix | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 12 change (n=150,158,173,187) | 0.54 kilograms | Standard Deviation 2.36 |
| Lispro Low Mix | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 24 change (n=144,151,163,176) | 0.73 kilograms | Standard Deviation 2.85 |
| Lispro Low Mix | ADDENDUM: Incremental Change From Baseline in Body Weight | Endpoint change (n=163,169,191,198) | 0.55 kilograms | Standard Deviation 2.85 |
| Lispro Low Mix | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 6 change (n=161,162,183,193) | 0.28 kilograms | Standard Deviation 1.76 |
| Lispro Low Mix | ADDENDUM: Incremental Change From Baseline in Body Weight | Baseline (n=170,173,198,200) | 93.63 kilograms | Standard Deviation 24.21 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 12 change (n=150,158,173,187) | 0.27 kilograms | Standard Deviation 3.31 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Incremental Change From Baseline in Body Weight | Baseline (n=170,173,198,200) | 89.25 kilograms | Standard Deviation 21.62 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 6 change (n=161,162,183,193) | 0.32 kilograms | Standard Deviation 2.15 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 24 change (n=144,151,163,176) | 1.03 kilograms | Standard Deviation 3.24 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Incremental Change From Baseline in Body Weight | Endpoint change (n=163,169,191,198) | 0.86 kilograms | Standard Deviation 3.41 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 24 change (n=144,151,163,176) | 1.51 kilograms | Standard Deviation 3.11 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 6 change (n=161,162,183,193) | 0.64 kilograms | Standard Deviation 2.1 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Incremental Change From Baseline in Body Weight | Baseline (n=170,173,198,200) | 90.09 kilograms | Standard Deviation 23.45 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Incremental Change From Baseline in Body Weight | Week 12 change (n=150,158,173,187) | 0.83 kilograms | Standard Deviation 2.37 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Incremental Change From Baseline in Body Weight | Endpoint change (n=163,169,191,198) | 1.42 kilograms | Standard Deviation 3.03 |
p-value: 0.745ANOVA
p-value: 0.467ANOVA
p-value: 0.575ANCOVA
p-value: 0.726ANCOVA
p-value: 0.978ANCOVA
p-value: 0.345ANCOVA
p-value: 0.166ANCOVA
p-value: 0.064ANCOVA
p-value: 0.199ANCOVA
p-value: 0.098ANCOVA
Secondary
ADDENDUM: Insulin Dose
Time frame: Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | ADDENDUM: Insulin Dose | Week 12 (n=152,161,177,190) | 0.80 units/kg/day | Standard Deviation 0.33 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Week 24 (n=147,151,166,179) | 0.82 units/kg/day | Standard Deviation 0.35 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Week 2 (n=147,159,180,187) | 0.63 units/kg/day | Standard Deviation 0.29 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Endpoint (n=165,170,199,200) | 0.81 units/kg/day | Standard Deviation 0.35 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Baseline (n=171,174,199,200) | 0.55 units/kg/day | Standard Deviation 0.26 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Week 3 (n=149,158,179,184) | 0.65 units/kg/day | Standard Deviation 0.28 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Week 4 (n=145,157,178,178) | 0.69 units/kg/day | Standard Deviation 0.29 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Week 6 (n=162,168,190,196) | 0.73 units/kg/day | Standard Deviation 0.29 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Week 5 (n=148,153,172,173) | 0.73 units/kg/day | Standard Deviation 0.29 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Week 8 (n=139,154,164,174) | 0.76 units/kg/day | Standard Deviation 0.29 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Week 1 (n=152,158,183,183) | 0.58 units/kg/day | Standard Deviation 0.26 |
| Insulin Glargine | ADDENDUM: Insulin Dose | Week 10 (n=141,152,158,174) | 0.78 units/kg/day | Standard Deviation 0.31 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Week 8 (n=139,154,164,174) | 0.75 units/kg/day | Standard Deviation 0.32 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Week 12 (n=152,161,177,190) | 0.79 units/kg/day | Standard Deviation 0.33 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Week 4 (n=145,157,178,178) | 0.67 units/kg/day | Standard Deviation 0.27 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Week 3 (n=149,158,179,184) | 0.64 units/kg/day | Standard Deviation 0.26 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Week 6 (n=162,168,190,196) | 0.72 units/kg/day | Standard Deviation 0.29 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Week 24 (n=147,151,166,179) | 0.80 units/kg/day | Standard Deviation 0.35 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Week 5 (n=148,153,172,173) | 0.70 units/kg/day | Standard Deviation 0.28 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Week 10 (n=141,152,158,174) | 0.77 units/kg/day | Standard Deviation 0.32 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Week 1 (n=152,158,183,183) | 0.57 units/kg/day | Standard Deviation 0.25 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Endpoint (n=165,170,199,200) | 0.79 units/kg/day | Standard Deviation 0.35 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Baseline (n=171,174,199,200) | 0.55 units/kg/day | Standard Deviation 0.25 |
| Lispro Low Mix | ADDENDUM: Insulin Dose | Week 2 (n=147,159,180,187) | 0.59 units/kg/day | Standard Deviation 0.26 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Week 10 (n=141,152,158,174) | 0.76 units/kg/day | Standard Deviation 0.43 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Week 3 (n=149,158,179,184) | 0.57 units/kg/day | Standard Deviation 0.28 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Week 8 (n=139,154,164,174) | 0.71 units/kg/day | Standard Deviation 0.38 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Week 4 (n=145,157,178,178) | 0.63 units/kg/day | Standard Deviation 0.34 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Week 5 (n=148,153,172,173) | 0.65 units/kg/day | Standard Deviation 0.34 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Baseline (n=171,174,199,200) | 0.46 units/kg/day | Standard Deviation 0.27 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Week 2 (n=147,159,180,187) | 0.54 units/kg/day | Standard Deviation 0.29 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Week 12 (n=152,161,177,190) | 0.77 units/kg/day | Standard Deviation 0.42 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Week 1 (n=152,158,183,183) | 0.49 units/kg/day | Standard Deviation 0.27 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Week 24 (n=147,151,166,179) | 0.79 units/kg/day | Standard Deviation 0.45 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Week 6 (n=162,168,190,196) | 0.68 units/kg/day | Standard Deviation 0.37 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Insulin Dose | Endpoint (n=165,170,199,200) | 0.77 units/kg/day | Standard Deviation 0.43 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Endpoint (n=165,170,199,200) | 0.76 units/kg/day | Standard Deviation 0.33 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Baseline (n=171,174,199,200) | 0.46 units/kg/day | Standard Deviation 0.24 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Week 1 (n=152,158,183,183) | 0.49 units/kg/day | Standard Deviation 0.25 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Week 2 (n=147,159,180,187) | 0.53 units/kg/day | Standard Deviation 0.24 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Week 3 (n=149,158,179,184) | 0.58 units/kg/day | Standard Deviation 0.24 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Week 5 (n=148,153,172,173) | 0.65 units/kg/day | Standard Deviation 0.26 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Week 6 (n=162,168,190,196) | 0.66 units/kg/day | Standard Deviation 0.28 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Week 8 (n=139,154,164,174) | 0.69 units/kg/day | Standard Deviation 0.29 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Week 10 (n=141,152,158,174) | 0.73 units/kg/day | Standard Deviation 0.31 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Week 12 (n=152,161,177,190) | 0.74 units/kg/day | Standard Deviation 0.32 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Week 24 (n=147,151,166,179) | 0.76 units/kg/day | Standard Deviation 0.32 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Insulin Dose | Week 4 (n=145,157,178,178) | 0.61 units/kg/day | Standard Deviation 0.25 |
p-value: 0.837ANOVA
p-value: 0.205ANOVA
p-value: 0.704ANOVA
p-value: 0.61ANOVA
p-value: 0.352ANOVA
p-value: 0.636ANOVA
p-value: 0.88ANOVA
p-value: 0.904ANOVA
p-value: 0.859ANOVA
p-value: 0.654ANOVA
p-value: 0.566ANOVA
p-value: 0.926ANOVA
p-value: 0.902ANOVA
p-value: 0.766ANOVA
p-value: 0.449ANOVA
p-value: 0.797ANOVA
p-value: 0.438ANOVA
p-value: 0.602ANOVA
p-value: 0.493ANOVA
p-value: 0.335ANOVA
p-value: 0.398ANOVA
p-value: 0.903ANOVA
Secondary
ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%
Time frame: Endpoint (Addendum: 24 weeks [Week 48])
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <=7.0% | 12.5 percent of participants |
| Insulin Glargine | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <=6.5% | 4.4 percent of participants |
| Insulin Glargine | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <7.0% | 8.8 percent of participants |
| Lispro Low Mix | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <=7.0% | 16.0 percent of participants |
| Lispro Low Mix | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <=6.5% | 3.7 percent of participants |
| Lispro Low Mix | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <7.0% | 13.9 percent of participants |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <7.0% | 17.6 percent of participants |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <=7.0% | 22.0 percent of participants |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <=6.5% | 5.0 percent of participants |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <=7.0% | 18.2 percent of participants |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <=6.5% | 4.0 percent of participants |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5% | <7.0% | 4.0 percent of participants |
p-value: 0.027Fisher Exact
p-value: 0.021Fisher Exact
p-value: 0.799Fisher Exact
p-value: 0.676Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
Secondary
ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Time frame: Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes overall | 0.0 percentage of participants |
| Insulin Glargine | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Hypoglycemia episodes endpoint | 40.9 percentage of participants |
| Insulin Glargine | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes endpoint | 0.0 percentage of participants |
| Insulin Glargine | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Overall hypoglycemia episodes | 53.7 percentage of participants |
| Insulin Glargine | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes endpoint | 25.0 percentage of participants |
| Insulin Glargine | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes overall | 31.1 percentage of participants |
| Lispro Low Mix | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes endpoint | 20.5 percentage of participants |
| Lispro Low Mix | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes overall | 31.0 percentage of participants |
| Lispro Low Mix | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Overall hypoglycemia episodes | 56.1 percentage of participants |
| Lispro Low Mix | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes endpoint | 0.0 percentage of participants |
| Lispro Low Mix | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Hypoglycemia episodes endpoint | 41.5 percentage of participants |
| Lispro Low Mix | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes overall | 1.2 percentage of participants |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Overall hypoglycemia episodes | 47.9 percentage of participants |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes endpoint | 19.3 percentage of participants |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes overall | 0.0 percentage of participants |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Hypoglycemia episodes endpoint | 34.9 percentage of participants |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes endpoint | 0.0 percentage of participants |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes overall | 27.1 percentage of participants |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes overall | 36.9 percentage of participants |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Overall hypoglycemia episodes | 56.1 percentage of participants |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes endpoint | 0.0 percentage of participants |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes overall | 1.0 percentage of participants |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes endpoint | 23.7 percentage of participants |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes | Hypoglycemia episodes endpoint | 40.9 percentage of participants |
p-value: 0.25Cochran-Mantel-Haenszel
p-value: 0.953Cochran-Mantel-Haenszel
p-value: 0.953Cochran-Mantel-Haenszel
p-value: 0.188Cochran-Mantel-Haenszel
p-value: 0.226Cochran-Mantel-Haenszel
p-value: 0.855Cochran-Mantel-Haenszel
p-value: 0.123Cochran-Mantel-Haenszel
p-value: 0.166Cochran-Mantel-Haenszel
p-value: 0.273Cochran-Mantel-Haenszel
p-value: 0.039Cochran-Mantel-Haenszel
Secondary
ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Time frame: Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Addendum baseline: 24 weeks: Week 48.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Endpoint | 11.10 episodes/participant/year | Standard Deviation 20.36 |
| Insulin Glargine | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Overall | 11.54 episodes/participant/year | Standard Deviation 18.7 |
| Insulin Glargine | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Endpoint | 2.46 episodes/participant/year | Standard Deviation 8.14 |
| Insulin Glargine | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Overall | 2.47 episodes/participant/year | Standard Deviation 6.29 |
| Insulin Glargine | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Endpoint | 0.00 episodes/participant/year | Standard Deviation 0 |
| Insulin Glargine | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Overall | 0.02 episodes/participant/year | Standard Deviation 0.23 |
| Lispro Low Mix | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Overall | 0.02 episodes/participant/year | Standard Deviation 0.21 |
| Lispro Low Mix | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Overall | 3.14 episodes/participant/year | Standard Deviation 6.58 |
| Lispro Low Mix | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Endpoint | 10.11 episodes/participant/year | Standard Deviation 21.84 |
| Lispro Low Mix | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Endpoint | 2.51 episodes/participant/year | Standard Deviation 7.03 |
| Lispro Low Mix | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Overall | 10.73 episodes/participant/year | Standard Deviation 18.06 |
| Lispro Low Mix | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Endpoint | 0.00 episodes/participant/year | Standard Deviation 0 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Overall | 11.39 episodes/participant/year | Standard Deviation 22.75 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Endpoint | 2.37 episodes/participant/year | Standard Deviation 6.1 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Overall | 2.09 episodes/participant/year | Standard Deviation 5.25 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Overall | 0.00 episodes/participant/year | Standard Deviation 0 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Endpoint | 0.00 episodes/participant/year | Standard Deviation 0 |
| Basal Bolus Prior Lispro Low Mix Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Endpoint | 12.11 episodes/participant/year | Standard Deviation 28.2 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Endpoint | 0.00 episodes/participant/year | Standard Deviation 0 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Overall | 0.00 episodes/participant/year | Standard Deviation 0 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Overall | 9.04 episodes/participant/year | Standard Deviation 21.45 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Overall | 2.15 episodes/participant/year | Standard Deviation 5.56 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Endpoint | 11.18 episodes/participant/year | Standard Deviation 44.8 |
| Basal Bolus Prior Glargine Addendum | ADDENDUM: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Endpoint | 3.01 episodes/participant/year | Standard Deviation 13.62 |
p-value: 0.623ANOVA
p-value: 0.949ANOVA
p-value: 0.73ANOVA
p-value: 0.445ANOVA
p-value: 0.949ANOVA
p-value: 0.59ANOVA
p-value: 0.657ANOVA
p-value: 0.108ANOVA
p-value: 0.161ANOVA
p-value: 0.178ANOVA
Secondary
INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Time frame: Endpoint (LOCF) (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Midday 2-hour postprandial BG (n=929,916) | 169.38 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 46.78 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | AM/PM 2-hour postprandial BG (n=935,921) | 173.73 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 42.83 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline mean fasting blood glucose (n=986,993) | 196.16 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 55.14 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Mean fasting blood glucose (n=938,922) | 121.52 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 33.41 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline AM 2-hour postprandial BG (n=977,989) | 251.45 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 64.78 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | AM 2-hour postprandial blood glucose (n=932,920) | 171.79 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 49.14 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline midday premeal BG (n=976,988) | 203.87 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 67.31 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Midday premeal blood glucose (BG) (n=934,919) | 137.43 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 44.05 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline midday 2-hour postprandial BG (n=974,988) | 232.73 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 68.84 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline evening pre-meal BG (n=983,993) | 203.33 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 66.5 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Evening pre-meal blood glucose (n=936,922) | 141.86 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 45.44 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline evening 2hour postprandial BG (n=983,991) | 239.73 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 70.28 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Evening 2-hour postprandial BG (n=932,921) | 175.73 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 48.66 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline 3 AM blood glucose (n=955,975) | 197.99 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 64.28 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | 3 AM blood glucose (n=912,899) | 131.08 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 42.38 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline AM 2-hour BG excursion (n=975,987) | 55.32 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 46.93 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | AM 2-hour blood glucose excursion (n=932,920) | 50.57 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 43.59 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline midday 2-hour BG excursion (n=966,981) | 26.60 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 48.5 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Midday 2-hour blood glucose excursion (n=928,916) | 32.21 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 40.4 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline PM 2-hour BG excursion (n=979,988) | 36.50 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 46.11 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | PM 2-hour blood glucose excursion (n=929,921) | 34.17 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 40.3 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline mean all meal time excursions (n=985,991) | 40.80 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 29.92 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Mean of all meal time excursions (n=935,921) | 38.96 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 27.22 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline mean all 2hour PP BG (n=986,993) | 241.58 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 61.06 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Mean of all 2-hour postprandial BG (n=935,921) | 172.28 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 41.04 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline AM/PM 2-hour postprandial BG (n=986,993) | 245.67 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 62.02 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline mean all premeal BG (n=988,994) | 201.29 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 57.4 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Mean of all premeal blood glucose (n=938,922) | 133.62 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 34.09 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline AM/PM 2-hour BG excursion (n=985,991) | 46.05 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 35.06 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | AM/PM 2-hour blood glucose excursion (n=935,921) | 42.42 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 31.96 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline mean of all BG values (n=989,995) | 218.05 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 56.55 |
| Insulin Glargine | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Mean of all blood glucose values (n=938,922) | 149.89 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 34.32 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Mean of all blood glucose values (n=938,922) | 147.96 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 32.92 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | AM 2-hour blood glucose excursion (n=932,920) | 34.01 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 45.04 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Mean of all 2-hour postprandial BG (n=935,921) | 166.17 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 39.82 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline mean fasting blood glucose (n=986,993) | 192.91 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 53.22 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline midday 2-hour BG excursion (n=966,981) | 28.08 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 45.09 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Mean fasting blood glucose (n=938,922) | 133.54 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 35 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline AM/PM 2-hour BG excursion (n=985,991) | 48.11 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 35.77 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline AM 2-hour postprandial BG (n=977,989) | 252.46 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 64.54 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Midday 2-hour blood glucose excursion (n=928,916) | 37.46 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 44.4 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | AM 2-hour postprandial blood glucose (n=932,920) | 167.40 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 49.46 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | AM/PM 2-hour postprandial BG (n=935,921) | 165.19 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 41.71 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline midday premeal BG (n=976,988) | 203.76 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 65.93 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline PM 2-hour BG excursion (n=979,988) | 36.31 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 44.37 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Midday premeal blood glucose (BG) (n=934,919) | 130.36 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 42.44 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline mean of all BG values (n=989,995) | 216.12 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 54.4 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline midday 2-hour postprandial BG (n=974,988) | 231.53 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 66.18 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline AM/PM 2-hour postprandial BG (n=986,993) | 244.36 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 59.24 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Midday 2-hour postprandial BG (n=929,916) | 167.91 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 48 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | PM 2-hour blood glucose excursion (n=929,921) | 19.51 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 42.9 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline evening pre-meal BG (n=983,993) | 200.36 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 64.56 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline mean all premeal BG (n=988,994) | 198.97 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 54.87 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Evening pre-meal blood glucose (n=936,922) | 143.44 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 43.09 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline mean all meal time excursions (n=985,991) | 41.63 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 28.58 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline evening 2hour postprandial BG (n=983,991) | 236.33 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 64.92 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | AM/PM 2-hour blood glucose excursion (n=935,921) | 26.74 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 34.01 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Evening 2-hour postprandial BG (n=932,921) | 163.20 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 46.67 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Mean of all meal time excursions (n=935,921) | 30.34 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 28.22 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline 3 AM blood glucose (n=955,975) | 194.11 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 61.96 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Mean of all premeal blood glucose (n=938,922) | 135.80 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 32.8 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | 3 AM blood glucose (n=912,899) | 129.70 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 40.51 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline mean all 2hour PP BG (n=986,993) | 240.08 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 58.15 |
| Lispro Low Mix | INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions | Baseline AM 2-hour BG excursion (n=975,987) | 60.06 milligrams per 100 Milliliters (mg/dL) | Standard Deviation 47.21 |
p-value: 0.179ANOVA
p-value: <0.001ANCOVA
p-value: 0.7ANOVA
p-value: 0.016ANCOVA
p-value: 0.971ANOVA
p-value: <0.001ANCOVA
p-value: 0.759ANOVA
p-value: 0.514ANCOVA
p-value: 0.321ANOVA
p-value: 0.161ANCOVA
p-value: 0.297ANOVA
p-value: <0.001ANCOVA
p-value: 0.199ANOVA
p-value: 0.693ANCOVA
p-value: 0.021ANOVA
p-value: <0.001ANCOVA
p-value: 0.567ANOVA
p-value: 0.005ANCOVA
p-value: 0.994ANOVA
p-value: <0.001ANCOVA
p-value: 0.436ANOVA
p-value: <0.001ANCOVA
p-value: 0.628ANOVA
p-value: <0.001ANCOVA
p-value: 0.677ANOVA
p-value: <0.001ANCOVA
p-value: 0.364ANOVA
p-value: 0.055ANCOVA
p-value: 0.165ANOVA
p-value: <0.001ANCOVA
p-value: 0.464ANOVA
p-value: 0.305ANCOVA
Secondary
INITIATION: Body Weight
Time frame: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | INITIATION: Body Weight | Actual weight at Baseline (n=1046,1044) | 88.23 kilograms | Standard Deviation 20.78 |
| Insulin Glargine | INITIATION: Body Weight | Actual weight at Week 6 (n=1008,995) | 89.24 kilograms | Standard Deviation 20.88 |
| Insulin Glargine | INITIATION: Body Weight | Actual weight at Week 12 (n=970,960) | 89.80 kilograms | Standard Deviation 20.96 |
| Insulin Glargine | INITIATION: Body Weight | Actual weight at Week 18 (n=943,927) | 90.33 kilograms | Standard Deviation 21.17 |
| Insulin Glargine | INITIATION: Body Weight | Actual weight at Week 24 (n=925,911) | 90.78 kilograms | Standard Deviation 21.46 |
| Insulin Glargine | INITIATION: Body Weight | Actual weight Endpoint (n=1016,1008) | 90.74 kilograms | Standard Deviation 21.36 |
| Lispro Low Mix | INITIATION: Body Weight | Actual weight at Week 24 (n=925,911) | 92.63 kilograms | Standard Deviation 21.23 |
| Lispro Low Mix | INITIATION: Body Weight | Actual weight at Baseline (n=1046,1044) | 88.84 kilograms | Standard Deviation 20.97 |
| Lispro Low Mix | INITIATION: Body Weight | Actual weight at Week 18 (n=943,927) | 92.46 kilograms | Standard Deviation 21.27 |
| Lispro Low Mix | INITIATION: Body Weight | Actual weight at Week 6 (n=1008,995) | 90.63 kilograms | Standard Deviation 20.94 |
| Lispro Low Mix | INITIATION: Body Weight | Actual weight Endpoint (n=1016,1008) | 92.67 kilograms | Standard Deviation 21.19 |
| Lispro Low Mix | INITIATION: Body Weight | Actual weight at Week 12 (n=970,960) | 91.79 kilograms | Standard Deviation 21.16 |
p-value: 0.497ANOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.0001ANCOVA
Secondary
INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)
Time frame: Baseline (Initiation), Endpoint (Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG) | 4.61 micrograms per milliliter (ug/mL) | Standard Deviation 4.85 |
| Lispro Low Mix | INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG) | 5.25 micrograms per milliliter (ug/mL) | Standard Deviation 4.85 |
p-value: 0.003ANCOVA
Secondary
INITIATION: Change in HbA1c From Baseline to 24 Weeks
Time frame: Baseline (Initiation) to Endpoint (LOCF, Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | INITIATION: Change in HbA1c From Baseline to 24 Weeks | -1.68 percent glycosylated hemoglobin | Standard Deviation 1.27 |
| Lispro Low Mix | INITIATION: Change in HbA1c From Baseline to 24 Weeks | -1.83 percent glycosylated hemoglobin | Standard Deviation 1.27 |
p-value: 0.005ANCOVA
Secondary
INITIATION: HbA1c
Time frame: Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | INITIATION: HbA1c | Baseline (n=1030,1017) | 9.02 percent glycosylated hemoglobin | Standard Deviation 1.24 |
| Insulin Glargine | INITIATION: HbA1c | Week 12 (n=952,953) | 7.42 percent glycosylated hemoglobin | Standard Deviation 0.95 |
| Insulin Glargine | INITIATION: HbA1c | Week 24 (n=922,911) | 7.28 percent glycosylated hemoglobin | Standard Deviation 1.06 |
| Insulin Glargine | INITIATION: HbA1c | Endpoint (LOCF) (n=990,986) | 7.33 percent glycosylated hemoglobin | Standard Deviation 1.07 |
| Lispro Low Mix | INITIATION: HbA1c | Endpoint (LOCF) (n=990,986) | 7.23 percent glycosylated hemoglobin | Standard Deviation 1.08 |
| Lispro Low Mix | INITIATION: HbA1c | Baseline (n=1030,1017) | 9.06 percent glycosylated hemoglobin | Standard Deviation 1.29 |
| Lispro Low Mix | INITIATION: HbA1c | Week 24 (n=922,911) | 7.19 percent glycosylated hemoglobin | Standard Deviation 1.03 |
| Lispro Low Mix | INITIATION: HbA1c | Week 12 (n=952,953) | 7.27 percent glycosylated hemoglobin | Standard Deviation 0.99 |
p-value: 0.416ANOVA
p-value: <0.001ANCOVA
p-value: 0.003ANCOVA
p-value: 0.005ANCOVA
Secondary
INITIATION: Incremental Change From Baseline in Body Weight
Time frame: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | INITIATION: Incremental Change From Baseline in Body Weight | Change from baseline at Week 12 (n=970, 960) | 1.60 kilograms (kg) | Standard Deviation 3.41 |
| Insulin Glargine | INITIATION: Incremental Change From Baseline in Body Weight | Change from baseline at Week 24 (n=925,911) | 2.59 kilograms (kg) | Standard Deviation 4.09 |
| Insulin Glargine | INITIATION: Incremental Change From Baseline in Body Weight | Change from baseline at Week 18 (n=943,927) | 2.24 kilograms (kg) | Standard Deviation 3.65 |
| Insulin Glargine | INITIATION: Incremental Change From Baseline in Body Weight | Change from baseline at endpoint (n=1016,1008) | 2.45 kilograms (kg) | Standard Deviation 4.02 |
| Insulin Glargine | INITIATION: Incremental Change From Baseline in Body Weight | Change from baseline at Week 6 (n=1008,995) | 0.97 kilograms (kg) | Standard Deviation 2.48 |
| Lispro Low Mix | INITIATION: Incremental Change From Baseline in Body Weight | Change from baseline at endpoint (n=1016,1008) | 3.60 kilograms (kg) | Standard Deviation 3.99 |
| Lispro Low Mix | INITIATION: Incremental Change From Baseline in Body Weight | Change from baseline at Week 6 (n=1008,995) | 1.66 kilograms (kg) | Standard Deviation 2.29 |
| Lispro Low Mix | INITIATION: Incremental Change From Baseline in Body Weight | Change from baseline at Week 12 (n=970, 960) | 2.63 kilograms (kg) | Standard Deviation 3.16 |
| Lispro Low Mix | INITIATION: Incremental Change From Baseline in Body Weight | Change from baseline at Week 18 (n=943,927) | 3.44 kilograms (kg) | Standard Deviation 3.65 |
| Lispro Low Mix | INITIATION: Incremental Change From Baseline in Body Weight | Change from baseline at Week 24 (n=925,911) | 3.76 kilograms (kg) | Standard Deviation 4 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
INITIATION: Insulin Dose
Time frame: Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | INITIATION: Insulin Dose | Week 1 (n=994,1001) | 0.13 units/kg/day | Standard Deviation 0.04 |
| Insulin Glargine | INITIATION: Insulin Dose | Week 2 (n=991, 987) | 0.18 units/kg/day | Standard Deviation 0.07 |
| Insulin Glargine | INITIATION: Insulin Dose | Week 3 (n=990,968) | 0.23 units/kg/day | Standard Deviation 0.09 |
| Insulin Glargine | INITIATION: Insulin Dose | Week 4 (n=971,958) | 0.26 units/kg/day | Standard Deviation 0.11 |
| Insulin Glargine | INITIATION: Insulin Dose | Week 5 (n=958,930) | 0.30 units/kg/day | Standard Deviation 0.14 |
| Insulin Glargine | INITIATION: Insulin Dose | Week 6 (n=998,1023) | 0.32 units/kg/day | Standard Deviation 0.15 |
| Insulin Glargine | INITIATION: Insulin Dose | Week 8 (n=949,933) | 0.34 units/kg/day | Standard Deviation 0.17 |
| Insulin Glargine | INITIATION: Insulin Dose | Week 10 (n=925,916) | 0.37 units/kg/day | Standard Deviation 0.19 |
| Insulin Glargine | INITIATION: Insulin Dose | Week 12 (n=970,972) | 0.38 units/kg/day | Standard Deviation 0.2 |
| Insulin Glargine | INITIATION: Insulin Dose | Week 18 (n=943,943) | 0.39 units/kg/day | Standard Deviation 0.22 |
| Insulin Glargine | INITIATION: Insulin Dose | Week 24 (n=915,920) | 0.41 units/kg/day | Standard Deviation 0.23 |
| Insulin Glargine | INITIATION: Insulin Dose | Endpoint (n=1029,1036) | 0.40 units/kg/day | Standard Deviation 0.23 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 24 (n=915,920) | 0.48 units/kg/day | Standard Deviation 0.23 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 1 (n=994,1001) | 0.24 units/kg/day | Standard Deviation 0.07 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 8 (n=949,933) | 0.42 units/kg/day | Standard Deviation 0.17 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 2 (n=991, 987) | 0.28 units/kg/day | Standard Deviation 0.09 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 18 (n=943,943) | 0.46 units/kg/day | Standard Deviation 0.21 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 3 (n=990,968) | 0.32 units/kg/day | Standard Deviation 0.1 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 10 (n=925,916) | 0.44 units/kg/day | Standard Deviation 0.18 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 4 (n=971,958) | 0.35 units/kg/day | Standard Deviation 0.12 |
| Lispro Low Mix | INITIATION: Insulin Dose | Endpoint (n=1029,1036) | 0.47 units/kg/day | Standard Deviation 0.23 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 5 (n=958,930) | 0.38 units/kg/day | Standard Deviation 0.14 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 12 (n=970,972) | 0.45 units/kg/day | Standard Deviation 0.19 |
| Lispro Low Mix | INITIATION: Insulin Dose | Week 6 (n=998,1023) | 0.39 units/kg/day | Standard Deviation 0.15 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: 0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG
Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Time frame: Endpoint (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG | 5.74 micrograms per milliliter (ug/mL) | Standard Deviation 4.37 |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG | 4.28 micrograms per milliliter (ug/mL) | Standard Deviation 3.64 |
p-value: <0.001ANOVA
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age
Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Time frame: Endpoint (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age | 58.21 years | Standard Deviation 9.31 |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age | 55.85 years | Standard Deviation 9.99 |
p-value: <0.001ANOVA
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
Comparison of baseline HbA1c percentage group (\<8.5,\>=8.5) between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Time frame: Endpoint (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group | <8.5% HbA1c | 464 participants |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group | >=8.5% HbA1c | 451 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group | <8.5% HbA1c | 220 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group | >=8.5% HbA1c | 665 participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c
Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Time frame: Endpoint (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c | 8.66 percent glycosylated hemoglobin | Standard Deviation 1.13 |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c | 9.40 percent glycosylated hemoglobin | Standard Deviation 1.25 |
p-value: <0.001ANOVA
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%). HOMA-IR = fasting insulin (milliunits per milliliter) \* fasting plasma glucose (millimoles per liter) / 22.5.
Time frame: Endpoint (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 4.44 units on a scale | Standard Deviation 3.73 |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 5.45 units on a scale | Standard Deviation 5.58 |
p-value: <0.001ANOVA
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Time frame: Endpoint (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | African Descent | 50 participants |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | Hispanic | 96 participants |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | Caucasian | 680 participants |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | East/Southeast Asian | 11 participants |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | Western Asian | 70 participants |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | Other | 20 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | Western Asian | 175 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | Caucasian | 521 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | African Descent | 44 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | East/Southeast Asian | 28 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | Hispanic | 102 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin | Other | 36 participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Time frame: Endpoint (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose | Pre Meals Blood Glucose (n=892,866) | 190.47 milligrams per deciliter (mg/dL) | Standard Deviation 49.67 |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose | Post Meals Blood Glucose (n=891,865) | 228.87 milligrams per deciliter (mg/dL) | Standard Deviation 54.58 |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose | Average of All Blood Glucose (n=894,866) | 206.43 milligrams per deciliter (mg/dL) | Standard Deviation 50.05 |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose | Fasting Blood Glucose (n=891,864) | 189.04 milligrams per deciliter (mg/dL) | Standard Deviation 48.73 |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose | Fasting Blood Glucose (n=891,864) | 201.22 milligrams per deciliter (mg/dL) | Standard Deviation 57.41 |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose | Pre Meals Blood Glucose (n=892,866) | 209.86 milligrams per deciliter (mg/dL) | Standard Deviation 59.08 |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose | Average of All Blood Glucose (n=894,866) | 227.77 milligrams per deciliter (mg/dL) | Standard Deviation 57.04 |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose | Post Meals Blood Glucose (n=891,865) | 252.90 milligrams per deciliter (mg/dL) | Standard Deviation 60.85 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary
INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
Time frame: Endpoint (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline | Sulfonylurea/Metformin | 563 participants |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline | TZD/Metformin | 95 participants |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline | Sulfonylurea/TZD | 51 participants |
| Insulin Glargine | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline | Patients with 3 drugs (Sulfonylurea/TZD/Metformin) | 208 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline | Patients with 3 drugs (Sulfonylurea/TZD/Metformin) | 184 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline | Sulfonylurea/Metformin | 631 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline | Sulfonylurea/TZD | 51 participants |
| Lispro Low Mix | INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline | TZD/Metformin | 35 participants |
p-value: <0.001Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: 0.969Cochran-Mantel-Haenszel
p-value: 0.225Cochran-Mantel-Haenszel
Secondary
INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
Time frame: Endpoint (Initiation: Week 24)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint | <=7.0% | 45.8 percentage of participants |
| Insulin Glargine | INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint | <7.0% | 40.3 percentage of participants |
| Insulin Glargine | INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint | <=6.5% | 22.2 percentage of participants |
| Lispro Low Mix | INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint | <=7.0% | 52.5 percentage of participants |
| Lispro Low Mix | INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint | <7.0% | 47.5 percentage of participants |
| Lispro Low Mix | INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint | <=6.5% | 24.6 percentage of participants |
p-value: 0.002Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: 0.174Cochran-Mantel-Haenszel
Secondary
INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Time frame: Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Overall hypoglycemic episodes | 76.7 percentage of participants |
| Insulin Glargine | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Hypoglycemic episodes endpoint | 51.8 percentage of participants |
| Insulin Glargine | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal hypoglycemic episodes endpoint | 34.3 percentage of participants |
| Insulin Glargine | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal hypoglycemic episodes overall | 58.4 percentage of participants |
| Insulin Glargine | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe hypoglycemic episodes endpoint | 0.2 percentage of participants |
| Insulin Glargine | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe hypoglycemic episodes overall | 1.2 percentage of participants |
| Lispro Low Mix | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe hypoglycemic episodes endpoint | 0.6 percentage of participants |
| Lispro Low Mix | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal hypoglycemic episodes overall | 59.6 percentage of participants |
| Lispro Low Mix | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Hypoglycemic episodes endpoint | 57.1 percentage of participants |
| Lispro Low Mix | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Overall hypoglycemic episodes | 80.5 percentage of participants |
| Lispro Low Mix | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe hypoglycemic episodes overall | 2.1 percentage of participants |
| Lispro Low Mix | INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal hypoglycemic episodes endpoint | 33.9 percentage of participants |
p-value: 0.016Cochran-Mantel-Haenszel
p-value: 0.037Cochran-Mantel-Haenszel
p-value: 0.834Cochran-Mantel-Haenszel
p-value: 0.585Cochran-Mantel-Haenszel
p-value: 0.241Cochran-Mantel-Haenszel
p-value: 0.08Cochran-Mantel-Haenszel
Secondary
INITIATION: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Time frame: Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Initiation baseline: Week 0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Endpoint | 11.42 Episodes/participant/year | Standard Deviation 25.31 |
| Insulin Glargine | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Overall | 9.80 Episodes/participant/year | Standard Deviation 17.5 |
| Insulin Glargine | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Endpoint | 0.02 Episodes/participant/year | Standard Deviation 0.38 |
| Insulin Glargine | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Overall | 0.03 Episodes/participant/year | Standard Deviation 0.31 |
| Insulin Glargine | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Endpoint | 20.28 Episodes/participant/year | Standard Deviation 38.25 |
| Insulin Glargine | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Overall | 18.14 Episodes/participant/year | Standard Deviation 28.05 |
| Lispro Low Mix | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Endpoint | 24.96 Episodes/participant/year | Standard Deviation 39.45 |
| Lispro Low Mix | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Endpoint | 8.86 Episodes/participant/year | Standard Deviation 19.27 |
| Lispro Low Mix | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Overall | 0.10 Episodes/participant/year | Standard Deviation 1.61 |
| Lispro Low Mix | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Overall | 9.22 Episodes/participant/year | Standard Deviation 16.66 |
| Lispro Low Mix | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Overall | 25.49 Episodes/participant/year | Standard Deviation 36.04 |
| Lispro Low Mix | INITIATION: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Endpoint | 0.09 Episodes/participant/year | Standard Deviation 0.1 |
p-value: 0.009ANOVA
p-value: 0.42ANOVA
p-value: 0.165ANOVA
p-value: 0.167ANOVA
p-value: 0.006ANOVA
p-value: <0.001ANOVA
Secondary
MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial. A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
Time frame: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline PM pre-meal blood glucose (n=402,455) | 190.06 mg/dL | Standard Deviation 57.83 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint mean fasting blood glucose (n=372,426) | 119.50 mg/dL | Standard Deviation 29.04 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline AM 2-hour (hr) postprandial (n=398,455) | 243.62 mg/dL | Standard Deviation 58.58 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint AM 2-hour postprandial (n=368,426) | 164.94 mg/dL | Standard Deviation 44.29 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline midday premeal blood glucose (n=400,454) | 193.21 mg/dL | Standard Deviation 61.66 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint midday premeal blood glucose (n=370,425) | 132.25 mg/dL | Standard Deviation 38.28 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline midday 2hr postprandial (n=397,456) | 217.67 mg/dL | Standard Deviation 61.9 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint midday 2hr postprandial (n=370,424) | 159.81 mg/dL | Standard Deviation 42.21 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline mean fasting blood glucose (n=403,456) | 190.90 mg/dL | Standard Deviation 48.9 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint PM pre-meal blood glucose (n=371,425) | 131.58 mg/dL | Standard Deviation 37.22 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline PM 2hr postprandial (n=399,455) | 223.83 mg/dL | Standard Deviation 62.7 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint PM 2hr postprandial (n=369,425) | 167.66 mg/dL | Standard Deviation 43.81 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline 3AM blood glucose (n=393,450) | 189.36 mg/dL | Standard Deviation 59.87 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint 3AM blood glucose (n=363,419) | 126.05 mg/dL | Standard Deviation 34.33 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline AM 2hr excursion (n=397,455) | 52.63 mg/dL | Standard Deviation 44.06 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint AM 2hr excursion (n=368,426) | 45.69 mg/dL | Standard Deviation 39.41 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline midday 2hr excursion (n=395,452) | 25.13 mg/dL | Standard Deviation 46.67 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint midday 2hr excursion (n=370,423) | 27.78 mg/dL | Standard Deviation 37.38 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline PM 2hr excursion (n=398,453) | 33.87 mg/dL | Standard Deviation 42.37 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint PM 2hr excursion (n=369,424) | 36.24 mg/dL | Standard Deviation 37.55 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline mean all meal time excursions (n=402,455) | 37.36 mg/dL | Standard Deviation 27.26 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint mean all meal time excursions (n=370,426) | 36.32 mg/dL | Standard Deviation 26.25 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline mean of all 2hr postprandial (n=402,457) | 228.52 mg/dL | Standard Deviation 54.01 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint mean of all 2hr postprandial (n=370,426) | 164.17 mg/dL | Standard Deviation 36.3 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline mean all premeal (n=404,456) | 191.46 mg/dL | Standard Deviation 50.02 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint mean all premeal (n=372,426) | 127.61 mg/dL | Standard Deviation 28.4 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline combined AM/PM 2hr postprandial (402,457) | 233.82 mg/dL | Standard Deviation 55.31 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint combined AM/PM 2hr postprandial (370,426) | 166.34 mg/dL | Standard Deviation 38.28 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline AM/PM 2hr postprandial excursion (402,455 | 43.46 mg/dL | Standard Deviation 32.72 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint AM/PM 2hr postprandial excursion (370,426 | 40.76 mg/dL | Standard Deviation 32.01 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline mean all blood glucose values (n=405,457) | 207.01 mg/dL | Standard Deviation 49.91 |
| Insulin Glargine | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint mean all blood glucose values (n=372,426) | 142.94 mg/dL | Standard Deviation 29.16 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint mean all blood glucose values (n=372,426) | 141.01 mg/dL | Standard Deviation 28.97 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline mean fasting blood glucose (n=403,456) | 187.12 mg/dL | Standard Deviation 48.16 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline midday 2hr excursion (n=395,452) | 27.02 mg/dL | Standard Deviation 43.17 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint mean fasting blood glucose (n=372,426) | 127.92 mg/dL | Standard Deviation 32.9 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline mean all premeal (n=404,456) | 188.95 mg/dL | Standard Deviation 48.34 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline AM 2-hour (hr) postprandial (n=398,455) | 243.55 mg/dL | Standard Deviation 61.38 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint midday 2hr excursion (n=370,423) | 32.03 mg/dL | Standard Deviation 38.64 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint AM 2-hour postprandial (n=368,426) | 161.37 mg/dL | Standard Deviation 44.66 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline AM/PM 2hr postprandial excursion (402,455 | 45.80 mg/dL | Standard Deviation 33.8 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline midday premeal blood glucose (n=400,454) | 192.02 mg/dL | Standard Deviation 60.21 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline PM 2hr excursion (n=398,453) | 34.78 mg/dL | Standard Deviation 44.4 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint midday premeal blood glucose (n=370,425) | 126.42 mg/dL | Standard Deviation 37.84 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint mean all premeal (n=372,426) | 129.16 mg/dL | Standard Deviation 29.41 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline midday 2hr postprandial (n=397,456) | 218.54 mg/dL | Standard Deviation 60.65 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint PM 2hr excursion (n=369,424) | 23.45 mg/dL | Standard Deviation 41.99 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint midday 2hr postprandial (n=370,424) | 158.58 mg/dL | Standard Deviation 40 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline mean all blood glucose values (n=405,457) | 205.17 mg/dL | Standard Deviation 48.86 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline PM pre-meal blood glucose (n=402,455) | 187.92 mg/dL | Standard Deviation 56.68 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline mean all meal time excursions (n=402,455) | 39.65 mg/dL | Standard Deviation 25.6 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint PM pre-meal blood glucose (n=371,425) | 133.15 mg/dL | Standard Deviation 37.3 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline combined AM/PM 2hr postprandial (402,457) | 233.25 mg/dL | Standard Deviation 55.06 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline PM 2hr postprandial (n=399,455) | 223.02 mg/dL | Standard Deviation 60.64 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint mean all meal time excursions (n=370,426) | 29.81 mg/dL | Standard Deviation 27.04 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint PM 2hr postprandial (n=369,425) | 156.48 mg/dL | Standard Deviation 44.1 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint AM/PM 2hr postprandial excursion (370,426 | 28.69 mg/dL | Standard Deviation 31.08 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline 3AM blood glucose (n=393,450) | 183.18 mg/dL | Standard Deviation 57.15 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline mean of all 2hr postprandial (n=402,457) | 228.39 mg/dL | Standard Deviation 53.63 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint 3AM blood glucose (n=363,419) | 123.43 mg/dL | Standard Deviation 35.37 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint combined AM/PM 2hr postprandial (370,426) | 158.97 mg/dL | Standard Deviation 38.59 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Baseline AM 2hr excursion (n=397,455) | 56.96 mg/dL | Standard Deviation 45.4 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint mean of all 2hr postprandial (n=370,426) | 158.91 mg/dL | Standard Deviation 36.07 |
| Lispro Low Mix | MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions | Endpoint AM 2hr excursion (n=368,426) | 33.61 mg/dL | Standard Deviation 38.67 |
p-value: 0.234ANCOVA
p-value: 0.175ANOVA
p-value: 0.869ANOVA
p-value: <0.001ANCOVA
p-value: 0.164ANOVA
p-value: 0.218ANOVA
p-value: <0.001ANCOVA
p-value: 0.897ANOVA
p-value: 0.138ANCOVA
p-value: 0.867ANOVA
p-value: 0.031ANCOVA
p-value: 0.792ANOVA
p-value: 0.51ANCOVA
p-value: 0.535ANOVA
p-value: 0.517ANCOVA
p-value: <0.001ANCOVA
p-value: 0.589ANOVA
p-value: 0.161ANCOVA
p-value: 0.674ANOVA
p-value: <0.001ANCOVA
p-value: 0.201ANOVA
p-value: <0.001ANCOVA
p-value: 0.956ANOVA
p-value: 0.019ANCOVA
p-value: 0.445ANOVA
p-value: 0.371ANOVA
p-value: 0.848ANOVA
p-value: 0.002ANCOVA
p-value: 0.281ANOVA
p-value: <0.001ANCOVA
p-value: 0.588ANOVA
p-value: 0.217ANCOVA
Secondary
MAINTENANCE: Body Weight
Time frame: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Body Weight | Week 48 (n=399,460) | 93.23 kilograms | Standard Deviation 20.53 |
| Insulin Glargine | MAINTENANCE: Body Weight | Week 84 (n=281,327) | 93.46 kilograms | Standard Deviation 20.56 |
| Insulin Glargine | MAINTENANCE: Body Weight | Week 36 (n=411, 465) | 93.13 kilograms | Standard Deviation 20.68 |
| Insulin Glargine | MAINTENANCE: Body Weight | Week 96 (n=248, 297) | 93.33 kilograms | Standard Deviation 20.14 |
| Insulin Glargine | MAINTENANCE: Body Weight | Week 60 (n=362,414) | 93.17 kilograms | Standard Deviation 20.6 |
| Insulin Glargine | MAINTENANCE: Body Weight | Week 108 (n=228,268) | 93.39 kilograms | Standard Deviation 20.23 |
| Insulin Glargine | MAINTENANCE: Body Weight | Week 24 (n=417, 470) | 92.64 kilograms | Standard Deviation 20.53 |
| Insulin Glargine | MAINTENANCE: Body Weight | Week 120 (n=204,253) | 93.99 kilograms | Standard Deviation 20.22 |
| Insulin Glargine | MAINTENANCE: Body Weight | Week 72 (n=315,372) | 93.62 kilograms | Standard Deviation 20.4 |
| Insulin Glargine | MAINTENANCE: Body Weight | Endpoint (n=414,470) | 94.14 kilograms | Standard Deviation 21.04 |
| Insulin Glargine | MAINTENANCE: Body Weight | Baseline (n=419,473) | 90.56 kilograms | Standard Deviation 20.12 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Endpoint (n=414,470) | 94.01 kilograms | Standard Deviation 19.92 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Baseline (n=419,473) | 88.62 kilograms | Standard Deviation 19.05 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Week 24 (n=417, 470) | 92.35 kilograms | Standard Deviation 19.1 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Week 36 (n=411, 465) | 93.24 kilograms | Standard Deviation 19.38 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Week 48 (n=399,460) | 93.57 kilograms | Standard Deviation 19.41 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Week 60 (n=362,414) | 94.57 kilograms | Standard Deviation 19.62 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Week 72 (n=315,372) | 95.50 kilograms | Standard Deviation 19.63 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Week 84 (n=281,327) | 95.63 kilograms | Standard Deviation 19.78 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Week 96 (n=248, 297) | 95.34 kilograms | Standard Deviation 19.5 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Week 108 (n=228,268) | 95.07 kilograms | Standard Deviation 19.61 |
| Lispro Low Mix | MAINTENANCE: Body Weight | Week 120 (n=204,253) | 94.82 kilograms | Standard Deviation 19.62 |
p-value: 0.128ANOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: 0.002ANCOVA
p-value: <0.001ANCOVA
Secondary
MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
Time frame: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol | Baseline | 5.66 ug/dL | Standard Deviation 4.34 |
| Insulin Glargine | MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol | Endpoint | 10.48 ug/dL | Standard Deviation 6.26 |
| Insulin Glargine | MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol | Change | 4.82 ug/dL | Standard Deviation 5.28 |
| Lispro Low Mix | MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol | Baseline | 5.87 ug/dL | Standard Deviation 4.51 |
| Lispro Low Mix | MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol | Endpoint | 11.71 ug/dL | Standard Deviation 6.44 |
| Lispro Low Mix | MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol | Change | 5.84 ug/dL | Standard Deviation 5.19 |
p-value: 0.004ANCOVA
Secondary
MAINTENANCE: Change From Baseline to Endpoint in HbA1c
Time frame: Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Change From Baseline to Endpoint in HbA1c | Baseline at Week 0 (n=415,464) | 8.59 percent glycosylated hemoglobin | Standard Deviation 1.08 |
| Insulin Glargine | MAINTENANCE: Change From Baseline to Endpoint in HbA1c | Change from baseline to endpoint (n=409,462) | -1.38 percent glycosylated hemoglobin | Standard Deviation 1.18 |
| Insulin Glargine | MAINTENANCE: Change From Baseline to Endpoint in HbA1c | Change Week 24 to Week 120 endpoint (n=412,469) | 0.71 percent glycosylated hemoglobin | Standard Deviation 0.11 |
| Lispro Low Mix | MAINTENANCE: Change From Baseline to Endpoint in HbA1c | Baseline at Week 0 (n=415,464) | 8.69 percent glycosylated hemoglobin | Standard Deviation 1.16 |
| Lispro Low Mix | MAINTENANCE: Change From Baseline to Endpoint in HbA1c | Change from baseline to endpoint (n=409,462) | -1.59 percent glycosylated hemoglobin | Standard Deviation 1.22 |
| Lispro Low Mix | MAINTENANCE: Change From Baseline to Endpoint in HbA1c | Change Week 24 to Week 120 endpoint (n=412,469) | 0.61 percent glycosylated hemoglobin | Standard Deviation 0.75 |
p-value: 0.204ANOVA
p-value: 0.017ANCOVA
p-value: 0.02ANCOVA
Secondary
MAINTENANCE: HbA1c at Specified Visits and Endpoint
Time frame: Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 0 (n=415,464) | 8.59 percent glycosylated hemoglobin | Standard Deviation 1.08 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 12 (n=412,465) | 6.82 percent glycosylated hemoglobin | Standard Deviation 0.56 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 24 (n=418,471) | 6.49 percent glycosylated hemoglobin | Standard Deviation 0.4 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 36 (n=403,460) | 6.72 percent glycosylated hemoglobin | Standard Deviation 0.6 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 48 (n=395,443) | 6.85 percent glycosylated hemoglobin | Standard Deviation 0.7 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 60 (n=332,403) | 6.85 percent glycosylated hemoglobin | Standard Deviation 0.63 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 72 (n=305,363) | 6.80 percent glycosylated hemoglobin | Standard Deviation 0.68 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 84 (n=268,312) | 6.79 percent glycosylated hemoglobin | Standard Deviation 0.6 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 96 (n=242,291) | 6.85 percent glycosylated hemoglobin | Standard Deviation 0.64 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 108 (n=219,257) | 6.83 percent glycosylated hemoglobin | Standard Deviation 0.63 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 120 (n=204,240) | 6.87 percent glycosylated hemoglobin | Standard Deviation 0.65 |
| Insulin Glargine | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Endpoint (n=414,470) | 7.20 percent glycosylated hemoglobin | Standard Deviation 0.82 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 120 (n=204,240) | 6.75 percent glycosylated hemoglobin | Standard Deviation 0.6 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 0 (n=415,464) | 8.69 percent glycosylated hemoglobin | Standard Deviation 1.16 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 72 (n=305,363) | 6.79 percent glycosylated hemoglobin | Standard Deviation 0.66 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 12 (n=412,465) | 6.75 percent glycosylated hemoglobin | Standard Deviation 1.16 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 108 (n=219,257) | 6.72 percent glycosylated hemoglobin | Standard Deviation 0.56 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 24 (n=418,471) | 6.49 percent glycosylated hemoglobin | Standard Deviation 0.42 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 84 (n=268,312) | 6.74 percent glycosylated hemoglobin | Standard Deviation 0.6 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 36 (n=403,460) | 6.71 percent glycosylated hemoglobin | Standard Deviation 0.61 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Endpoint (n=414,470) | 7.10 percent glycosylated hemoglobin | Standard Deviation 0.81 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 48 (n=395,443) | 6.80 percent glycosylated hemoglobin | Standard Deviation 0.7 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 96 (n=242,291) | 6.73 percent glycosylated hemoglobin | Standard Deviation 0.6 |
| Lispro Low Mix | MAINTENANCE: HbA1c at Specified Visits and Endpoint | Week 60 (n=332,403) | 6.83 percent glycosylated hemoglobin | Standard Deviation 0.63 |
p-value: 0.204ANOVA
p-value: 0.004ANCOVA
p-value: 0.657ANCOVA
p-value: 0.595ANCOVA
p-value: 0.142ANCOVA
p-value: 0.551ANCOVA
p-value: 0.779ANCOVA
p-value: 0.175ANCOVA
p-value: 0.018ANCOVA
p-value: 0.047ANCOVA
p-value: 0.027ANCOVA
p-value: 0.017ANCOVA
Secondary
MAINTENANCE: Incremental Change From Baseline in Body Weight
Time frame: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 48 (n=399,460) | 3.08 kilograms | Standard Deviation 4.46 |
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 84 (n=281,327) | 3.16 kilograms | Standard Deviation 5.2 |
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 36 (n=411,465) | 2.71 kilograms | Standard Deviation 4.22 |
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 96 (n=248,297) | 3.11 kilograms | Standard Deviation 5.35 |
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 60 (n=362,414) | 3.33 kilograms | Standard Deviation 4.76 |
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 108 (n=228,268) | 3.48 kilograms | Standard Deviation 5.65 |
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 24 (n=417,470) | 2.05 kilograms | Standard Deviation 3.79 |
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 120 (n=204,253) | 3.71 kilograms | Standard Deviation 5.47 |
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 72 (n=315,372) | 3.12 kilograms | Standard Deviation 5.15 |
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Endpoint (n=414,470) | 3.65 kilograms | Standard Deviation 5.6 |
| Insulin Glargine | MAINTENANCE: Incremental Change From Baseline in Body Weight | Baseline (n=419,473) | 90.56 kilograms | Standard Deviation 20.12 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Endpoint (n=414,470) | 5.40 kilograms | Standard Deviation 5.83 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Baseline (n=419,473) | 88.62 kilograms | Standard Deviation 19.05 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 24 (n=417,470) | 3.68 kilograms | Standard Deviation 3.89 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 36 (n=411,465) | 4.56 kilograms | Standard Deviation 4.44 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 48 (n=399,460) | 4.82 kilograms | Standard Deviation 4.81 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 60 (n=362,414) | 5.13 kilograms | Standard Deviation 5.22 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 72 (n=315,372) | 5.40 kilograms | Standard Deviation 5.72 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 84 (n=281,327) | 5.84 kilograms | Standard Deviation 5.87 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 96 (n=248,297) | 5.60 kilograms | Standard Deviation 5.68 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 108 (n=228,268) | 5.57 kilograms | Standard Deviation 5.66 |
| Lispro Low Mix | MAINTENANCE: Incremental Change From Baseline in Body Weight | Change from baseline at Week 120 (n=204,253) | 5.48 kilograms | Standard Deviation 5.88 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: 0.002ANCOVA
p-value: <0.001ANCOVA
Secondary
MAINTENANCE: Insulin Dose
Time frame: Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Insulin Dose | Week 48 (n=407,464) | 0.37 units/kg/day | Standard Deviation 0.2 |
| Insulin Glargine | MAINTENANCE: Insulin Dose | Week 84 (n=284,334) | 0.36 units/kg/day | Standard Deviation 0.2 |
| Insulin Glargine | MAINTENANCE: Insulin Dose | Week 36 (n=415,470) | 0.36 units/kg/day | Standard Deviation 0.19 |
| Insulin Glargine | MAINTENANCE: Insulin Dose | Week 96 (n=251,303) | 0.37 units/kg/day | Standard Deviation 0.21 |
| Insulin Glargine | MAINTENANCE: Insulin Dose | Week 60 (n=364,419) | 0.37 units/kg/day | Standard Deviation 0.19 |
| Insulin Glargine | MAINTENANCE: Insulin Dose | Week 24 (n=418,473) | 0.36 units/kg/day | Standard Deviation 0.19 |
| Insulin Glargine | MAINTENANCE: Insulin Dose | Week 120 (n=205,254) | 0.36 units/kg/day | Standard Deviation 0.2 |
| Insulin Glargine | MAINTENANCE: Insulin Dose | Week 72 (n=317,374) | 0.37 units/kg/day | Standard Deviation 0.2 |
| Insulin Glargine | MAINTENANCE: Insulin Dose | Endpoint (n=416,472) | 0.37 units/kg/day | Standard Deviation 0.21 |
| Insulin Glargine | MAINTENANCE: Insulin Dose | Week 108 (n=233,273) | 0.36 units/kg/day | Standard Deviation 0.2 |
| Lispro Low Mix | MAINTENANCE: Insulin Dose | Endpoint (n=416,472) | 0.45 units/kg/day | Standard Deviation 0.21 |
| Lispro Low Mix | MAINTENANCE: Insulin Dose | Week 24 (n=418,473) | 0.43 units/kg/day | Standard Deviation 0.19 |
| Lispro Low Mix | MAINTENANCE: Insulin Dose | Week 36 (n=415,470) | 0.44 units/kg/day | Standard Deviation 0.2 |
| Lispro Low Mix | MAINTENANCE: Insulin Dose | Week 48 (n=407,464) | 0.44 units/kg/day | Standard Deviation 0.2 |
| Lispro Low Mix | MAINTENANCE: Insulin Dose | Week 60 (n=364,419) | 0.44 units/kg/day | Standard Deviation 0.19 |
| Lispro Low Mix | MAINTENANCE: Insulin Dose | Week 72 (n=317,374) | 0.44 units/kg/day | Standard Deviation 0.2 |
| Lispro Low Mix | MAINTENANCE: Insulin Dose | Week 84 (n=284,334) | 0.44 units/kg/day | Standard Deviation 0.21 |
| Lispro Low Mix | MAINTENANCE: Insulin Dose | Week 96 (n=251,303) | 0.44 units/kg/day | Standard Deviation 0.21 |
| Lispro Low Mix | MAINTENANCE: Insulin Dose | Week 108 (n=233,273) | 0.43 units/kg/day | Standard Deviation 0.21 |
| Lispro Low Mix | MAINTENANCE: Insulin Dose | Week 120 (n=205,254) | 0.44 units/kg/day | Standard Deviation 0.21 |
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG | 6.29 ug/mL | Standard Deviation 4.6 |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG | 5.39 ug/mL | Standard Deviation 4.22 |
p-value: 0.004ANOVA
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c | 8.27 percent glycosylated hemoglobin | Standard Deviation 0.94 |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c | 8.77 percent glycosylated hemoglobin | Standard Deviation 1.11 |
p-value: <0.001ANOVA
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Comparison of baseline HbA1c group (\<8.5,\>=8.5) between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | Less than 8.5% HbA1c | 97 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | >=8.5% HbA1c | 46 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | Less than 8.5% HbA1c | 121 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | >=8.5% HbA1c | 149 participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes | 8.44 years | Standard Deviation 4.92 |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes | 9.70 years | Standard Deviation 6.12 |
p-value: 0.036ANOVA
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Comparison of duration of diabetes group (\<10, 10-\<20, \>=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | Less than 10 years | 96 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | 10 years to less than 20 years | 45 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | 20 or more years | 6 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | Less than 10 years | 152 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | 10 years to less than 20 years | 94 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | 20 or more years | 26 participants |
p-value: 0.028Cochran-Mantel-Haenszel
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Mean of post meals blood glucose (n=141,261) | 219.28 mg/dL | Standard Deviation 51.23 |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Average of all blood glucose (n=141,264) | 200.60 mg/dL | Standard Deviation 48.07 |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Mean of post meals blood glucose (n=141,261) | 233.51 mg/dL | Standard Deviation 54.9 |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Average of all blood glucose (n=141,264) | 210.44 mg/dL | Standard Deviation 50.63 |
p-value: 0.01ANOVA
p-value: 0.035ANOVA
Secondary
MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/TZD | 16 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/metformin | 73 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Metformin/TZD | 22 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/metformin/TZD | 33 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/metformin/TZD | 59 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/TZD | 13 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Metformin/TZD | 22 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/metformin | 175 participants |
p-value: 0.037Cochran-Mantel-Haenszel
p-value: 0.025Cochran-Mantel-Haenszel
p-value: 0.132Cochran-Mantel-Haenszel
p-value: 0.849Cochran-Mantel-Haenszel
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG | 5.93 ug/ml | Standard Deviation 4.17 |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG | 5.73 ug/ml | Standard Deviation 4.64 |
p-value: 0.553ANOVA
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c | 8.54 percent glycosylated hemoglobin | Standard Deviation 1.13 |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c | 8.80 percent glycosylated hemoglobin | Standard Deviation 1.17 |
p-value: 0.043ANOVA
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Comparison of baseline HbA1c group (\<8.5,\>=8.5) between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | Less than 8.5 | 110 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | 8.5 or more | 88 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | Less than 8.5 | 121 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group | 8.5 or more | 147 participants |
p-value: 0.032Cochran-Mantel-Haenszel
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes | 9.42 years | Standard Deviation 6.24 |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes | 9.87 years | Standard Deviation 6.38 |
p-value: 0.708ANOVA
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Comparison of duration of diabetes group (\<10, 10-\<20, \>=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | <10 years | 112 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | 10 to <20 years | 78 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | >=20 years | 12 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | <10 years | 148 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | 10 to <20 years | 97 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group | >=20 years | 26 participants |
p-value: 0.738Cochran-Mantel-Haenszel
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Mean of post meals blood glucose | 223.98 mg/dL | Standard Deviation 52.54 |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Average of all blood glucose | 201.42 mg/dL | Standard Deviation 48.42 |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Mean of post meals blood glucose | 231.66 mg/dL | Standard Deviation 54.3 |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose | Average of all blood glucose | 207.96 mg/dL | Standard Deviation 49.09 |
p-value: 0.516ANOVA
p-value: 0.425ANOVA
Secondary
MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not. Participants who maintained goal are those who did not fail during their duration on study. Failure is defined by HbA1c \> 7.0% with change \>= 0.4% from most recent HbA1c that was \<=7.0%.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/TZD | 14 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/metformin | 115 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Metformin/TZD | 25 participants |
| Insulin Glargine | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/metformin/TZD | 45 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/metformin/TZD | 59 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/TZD | 5 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Metformin/TZD | 21 participants |
| Lispro Low Mix | MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline | Sulfonylurea/metformin | 185 participants |
p-value: 0.006Cochran-Mantel-Haenszel
p-value: 0.048Cochran-Mantel-Haenszel
p-value: 0.258Cochran-Mantel-Haenszel
p-value: 0.848Cochran-Mantel-Haenszel
Secondary
MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
Time frame: Endpoint (LOCF) (Maintenance: up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5% | <=7.0% | 44.9 percentage of participants |
| Insulin Glargine | MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5% | <7.0% | 40.1 percentage of participants |
| Insulin Glargine | MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5% | <=6.5% | 23.7 percentage of participants |
| Lispro Low Mix | MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5% | <=7.0% | 49.1 percentage of participants |
| Lispro Low Mix | MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5% | <7.0% | 45.1 percentage of participants |
| Lispro Low Mix | MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5% | <=6.5% | 26.4 percentage of participants |
p-value: 0.134Cochran-Mantel-Haenszel
p-value: 0.089Cochran-Mantel-Haenszel
p-value: 0.235Cochran-Mantel-Haenszel
Secondary
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Overall hypoglycemic episodes endpoint (n=415,471) | 45.3 percentage of participants |
| Insulin Glargine | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Overall hypoglycemic episodes (n=419,473) | 94.0 percentage of participants |
| Insulin Glargine | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes endpoint (n=415,471) | 30.4 percentage of participants |
| Insulin Glargine | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes overall (n=419,473) | 81.1 percentage of participants |
| Insulin Glargine | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes endpoint (n=415,471) | 0.5 percentage of participants |
| Insulin Glargine | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes overall (n=419,473) | 2.9 percentage of participants |
| Lispro Low Mix | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes endpoint (n=415,471) | 0.6 percentage of participants |
| Lispro Low Mix | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Overall hypoglycemic episodes endpoint (n=415,471) | 49.9 percentage of participants |
| Lispro Low Mix | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes overall (n=419,473) | 84.4 percentage of participants |
| Lispro Low Mix | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Overall hypoglycemic episodes (n=419,473) | 97.9 percentage of participants |
| Lispro Low Mix | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Severe episodes overall (n=419,473) | 4.2 percentage of participants |
| Lispro Low Mix | MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes | Nocturnal episodes endpoint (n=415,471) | 28.9 percentage of participants |
p-value: 0.37Cochran-Mantel-Haenszel
p-value: 0.006Cochran-Mantel-Haenszel
p-value: 0.397Cochran-Mantel-Haenszel
p-value: 0.253Cochran-Mantel-Haenszel
p-value: 0.893Cochran-Mantel-Haenszel
p-value: 0.391Cochran-Mantel-Haenszel
Secondary
MAINTENANCE: Rate of Increase in HbA1c
Rate of increase: HbA1c change/time period (month).
Time frame: Endpoint (LOCF) (Maintenance: up to 2.5 years)
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Rate of Increase in HbA1c | 0.06 HbA1c percent increase per month | Standard Deviation 0.08 |
| Lispro Low Mix | MAINTENANCE: Rate of Increase in HbA1c | 0.05 HbA1c percent increase per month | Standard Deviation 0.09 |
p-value: 0.3ANCOVA
Secondary
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L). Severe hypoglycemia = participant requires assistance. Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
Time frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
Population: Last observation carried forward (LOCF) method was performed on the intent-to-treat (ITT) population who had at least 1 post-baseline assessment. Maintenance baseline: Week 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Endpoint | 16.41 episodes/participant/year | Standard Deviation 34.78 |
| Insulin Glargine | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Overall | 21.80 episodes/participant/year | Standard Deviation 26.77 |
| Insulin Glargine | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Endpoint | 7.70 episodes/participant/year | Standard Deviation 19.36 |
| Insulin Glargine | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Overall | 9.77 episodes/participant/year | Standard Deviation 15.01 |
| Insulin Glargine | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Endpoint | 0.23 episodes/participant/year | Standard Deviation 4.43 |
| Insulin Glargine | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Overall | 0.12 episodes/participant/year | Standard Deviation 2.12 |
| Lispro Low Mix | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Endpoint | 0.03 episodes/participant/year | Standard Deviation 0.46 |
| Lispro Low Mix | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Endpoint | 18.56 episodes/participant/year | Standard Deviation 35.5 |
| Lispro Low Mix | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Overall | 8.02 episodes/participant/year | Standard Deviation 13.49 |
| Lispro Low Mix | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Hypoglycemia episodes Overall | 26.08 episodes/participant/year | Standard Deviation 31.69 |
| Lispro Low Mix | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Severe episodes Overall | 0.03 episodes/participant/year | Standard Deviation 0.21 |
| Lispro Low Mix | MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes | Nocturnal episodes Endpoint | 5.86 episodes/participant/year | Standard Deviation 15.96 |
p-value: 0.497ANOVA
p-value: 0.071ANOVA
p-value: 0.065ANOVA
p-value: 0.021ANOVA
p-value: 0.2ANOVA
p-value: 0.208ANOVA