A Phase 3 interventional study of LY2963016 and Lantus in Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company. Completed at 52 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-09.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.
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Exclusion Criteria:
LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.
Drug: LY2963016 · Drug: Insulin Lispro
Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.
Drug: Lantus · Drug: Insulin Lispro
Administered subcutaneously
Administered subcutaneously
Administered subcutaneously
Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time frame: Baseline, Endpoint (up to 24 weeks)
Change From Baseline in Insulin Antibody Levels
Blood samples are collected from participants and percentage of insulin antibody binding was measured to determine the insulin antibody levels. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time frame: Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time frame: Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)
7-Point Self-Monitored Blood Glucose (SMBG) Profiles
7-point SMBG measurements are completed at the following timepoints: Morning (AM) Pre-Meal, AM Post-Prandial (PP), Midday (MD) Pre-Meal, MD PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Values for the 7-point SMBG profiles were averaged over the three 7-point SMBG profiles during 2-week period prior to each visit. If only 1 of the 3 days of data was collected, then the value of the 1 day was used. If only 2 of the 3 days of data were collected, then the average of the 2 days was used. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time frame: Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Glycemic Variability of Fasting Blood Glucose
Glycemic variability is the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning premeal blood glucose value from the 7-point self-monitoring blood glucose (SMBG) profiles. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time frame: Baseline and Endpoints (up to 24 weeks and up 52 weeks)
Change From Baseline in Body Weight
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time frame: Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Adult Low Blood Sugar Survey (ALBSS)
ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score (TS) range is 0 to 60 and Worry TS range is 0 to 72. Higher scores on "Behavior" items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on "Worry" items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time frame: Baseline and 24 weeks and Endpoint (up to 52 weeks)
Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. Items divided into 5 domains: Inconvenience of Regimen \[(IR) 5 items: scores range 5-35\], Lifestyle Flexibility \[(LF) 3 items: scores range 3-21\], Glycemic Control \[(GC) 3 items: scores range 3-21\], Hypoglycemic Control \[(HC) 5 items: scores range 5-35\], Insulin Delivery Device \[(IDD) 6 items: scores range 6-42\]. ITSQ Total Overall Scores range from 22-154. Data presented are the transformed score on a scale of 0-100, where transformed score=100×\[(7-raw score)/6\]. Higher scores indicate better treatment satisfaction. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time frame: Baseline and 24 weeks and Endpoint (up to 52 weeks)
Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])
Total daily insulin dose was adjusted for body weight \[units of insulin/kilogram/day (U/kg/day)\]. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time frame: Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])
Units of insulin taken daily were presented. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
Time frame: Endpoints [up to 24 weeks (wk) and up to 52 weeks]
Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with Hemoglobin A1c (HbA1c) \<7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (\<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.
Time frame: Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)
Incidence of Hypoglycemic Events
Incidence of hypoglycemic events is defined as the number of hypoglycemic events. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose (BG) concentration of ≤ 70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines \[American Diabetes Association (ADA) 2005\]. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
Time frame: Baseline through 24 weeks (wk) and 52 weeks
Rate Per 30 Days of Hypoglycemic Events
The rate of hypoglycemic events per 30 days is defined as the total number of events between visits divided by the actual number of days between visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤ 70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
Time frame: Baseline through 24 weeks (wk) and 52 weeks
| Milestone | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Started | 269 | 267 |
| Received at least 1 dose of study drug | 268 | 267 |
| Completed | 253 | 256 |
| Not completed | 16 | 11 |
| Withdrew: Adverse event | 2 | 3 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Physician decision | 2 | 2 |
| Withdrew: Withdrawal by subject | 10 | 5 |
| Milestone | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Started | 253 | 256 |
| Completed | 245 | 245 |
| Not completed | 8 | 11 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 2 | 5 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 5 | 3 |
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
| percentage of glycosylated hemoglobin | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c) | -0.352 ± 0.053 | -0.460 ± 0.054 |
Blood samples are collected from participants and percentage of insulin antibody binding was measured to determine the insulin antibody levels. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
| percentage of insulin antibody binding | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Change at 6 weeks (n=31, 38) | 0.30 ± 0.33 | -0.12 ± 0.33 |
| Change at 12 weeks (n=27, 36) | 0.02 ± 0.39 | -0.38 ± 0.39 |
| Change at Endpoint, up to 24 weeks (n=37, 47) | 0.47 ± 0.45 | 0.09 ± 0.44 |
| Change at Endpoint, up to 52 weeks (n=40, 47) | 0.87 ± 0.58 | 0.06 ± 0.56 |
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
| percentage of glycosylated hemoglobin | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Change at 6 weeks (n=265, 265) | -0.369 ± 0.038 | -0.362 ± 0.039 |
| Change at 12 weeks (n=261, 262) | -0.359 ± 0.049 | -0.472 ± 0.049 |
| Change at 24 weeks (n=256, 258) | -0.383 ± 0.053 | -0.481 ± 0.053 |
| Change at 36 weeks (n=253, 254) | -0.349 ± 0.056 | -0.408 ± 0.056 |
| Change at 52 weeks (n=248, 246) | -0.302 ± 0.059 | -0.306 ± 0.060 |
| Change at Endpoint, up to 52 weeks (n=267, 267) | -0.256 ± 0.057 | -0.276 ± 0.058 |
7-point SMBG measurements are completed at the following timepoints: Morning (AM) Pre-Meal, AM Post-Prandial (PP), Midday (MD) Pre-Meal, MD PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Values for the 7-point SMBG profiles were averaged over the three 7-point SMBG profiles during 2-week period prior to each visit. If only 1 of the 3 days of data was collected, then the value of the 1 day was used. If only 2 of the 3 days of data were collected, then the average of the 2 days was used. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
| millimoles per liter (mmol/L) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Baseline-AM Pre-Meal (n=266, 264) | 8.37 ± 0.18 | 8.19 ± 0.18 |
| Baseline-AM 2 hrs PP (n=263, 262) | 8.93 ± 0.19 | 9.41 ± 0.19 |
| Baseline-MD Pre-Meal (n=266, 265) | 7.86 ± 0.16 | 8.14 ± 0.16 |
| Baseline-MD 2 hrs PP (n=264, 264) | 9.12 ± 0.18 | 8.81 ± 0.18 |
| Baseline-EV Pre-Meal (n=264, 264) | 8.87 ± 0.19 | 8.82 ± 0.19 |
| Baseline-Bed Time (n=266, 264) | 9.26 ± 0.20 | 9.37 ± 0.20 |
| Baseline-0300 hrs (n=262, 257) | 8.27 ± 0.18 | 8.37 ± 0.18 |
| Endpoint, up to 24 wk-AM Pre-Meal (n=266, 264) | 7.98 ± 0.20 | 7.81 ± 0.20 |
| Endpoint, up to 24 wk-AM 2 hrs PP (n=263, 262) | 8.75 ± 0.20 | 8.50 ± 0.21 |
| Endpoint, up to 24 wk-MD Pre-Meal (n=266, 265) | 7.81 ± 0.19 | 7.84 ± 0.20 |
| Endpoint, up to 24 wk-MD 2 hrs PP (n=264, 264) | 8.50 ± 0.21 | 8.41 ± 0.21 |
| Endpoint, up to 24 wk-EV Pre-Meal (n=264, 264) | 8.82 ± 0.21 | 8.61 ± 0.22 |
| Endpoint, up to 24 wk-Bed Time (n=266, 264) | 8.61 ± 0.22 | 9.11 ± 0.22 |
| Endpoint, up to 24 wk-0300 hrs (n=262, 257) | 7.93 ± 0.20 | 8.38 ± 0.20 |
| Endpoint, up to 52 wk- AM Pre-Meal (n=266, 264) | 8.03 ± 0.20 | 8.29 ± 0.21 |
| Endpoint, up to 52 wk-AM 2 hrs PP (n=263, 262) | 8.55 ± 0.21 | 8.88 ± 0.21 |
| Endpoint, up to 52 wk-MD Pre-Meal (n=266, 265) | 7.96 ± 0.19 | 7.99 ± 0.19 |
| Endpoint, up to 52 wk-MD 2 hrs PP (n=264, 264) | 8.61 ± 0.21 | 8.74 ± 0.21 |
| Endpoint, up to 52 wk-EV Pre-Meal (n=264, 264) | 8.37 ± 0.21 | 8.38 ± 0.21 |
| Endpoint, up to 52 wk-Bed Time (n=266, 264) | 8.57 ± 0.21 | 9.06 ± 0.21 |
| Endpoint, up to 52 wk-0300 hrs (n=262, 257) | 8.22 ± 0.21 | 8.43 ± 0.22 |
Glycemic variability is the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning premeal blood glucose value from the 7-point self-monitoring blood glucose (SMBG) profiles. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
| millimoles per liter (mmol/L) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Baseline | 2.51 ± 0.12 | 2.68 ± 0.12 |
| Endpoint, up to 24 weeks | 2.25 ± 0.14 | 2.29 ± 0.14 |
| Endpoint, up to 52 weeks | 2.08 ± 0.13 | 2.34 ± 0.13 |
Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
| kilogram (kg) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Change at 6 weeks (n=265, 265) | 0.45 ± 0.09 | 0.42 ± 0.09 |
| Change at 12 weeks (n=261, 261) | 0.59 ± 0.13 | 0.48 ± 0.13 |
| Change at 18 weeks (n=258, 260) | 0.72 ± 0.15 | 0.55 ± 0.15 |
| Change at Endpoint, up to 24 weeks (n=268, 267) | 0.66 ± 0.17 | 0.42 ± 0.17 |
| Change at Endpoint, up to 52 weeks (n=268, 267) | 0.93 ± 0.21 | 0.59 ± 0.21 |
ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score (TS) range is 0 to 60 and Worry TS range is 0 to 72. Higher scores on "Behavior" items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on "Worry" items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
| units on a scale | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Baseline-Behavior TS (n=265, 263) | 13.63 ± 0.54 | 12.99 ± 0.54 |
| 24 weeks-Behavior TS (n=255, 257) | 12.73 ± 0.66 | 12.53 ± 0.66 |
| Endpoint, up to 52 weeks-Behavior TS (n=265, 263) | 13.19 ± 0.62 | 13.03 ± 0.62 |
| Baseline-Worry TS (n=265, 263) | 16.01 ± 0.83 | 14.81 ± 0.83 |
| 24 weeks-Worry TS (n=255, 258) | 15.39 ± 1.08 | 14.27 ± 1.08 |
| Endpoint, up to 52 weeks-Worry TS (n=265, 263) | 15.18 ± 1.03 | 14.93 ± 1.05 |
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. Items divided into 5 domains: Inconvenience of Regimen \[(IR) 5 items: scores range 5-35\], Lifestyle Flexibility \[(LF) 3 items: scores range 3-21\], Glycemic Control \[(GC) 3 items: scores range 3-21\], Hypoglycemic Control \[(HC) 5 items: scores range 5-35\], Insulin Delivery Device \[(IDD) 6 items: scores range 6-42\]. ITSQ Total Overall Scores range from 22-154. Data presented are the transformed score on a scale of 0-100, where transformed score=100×\[(7-raw score)/6\]. Higher scores indicate better treatment satisfaction. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
| units on a scale | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| IR-Baseline (n=264, 263) | 74.62 ± 1.31 | 75.39 ± 1.32 |
| IR-24 weeks (n=254, 258) | 79.32 ± 1.62 | 78.76 ± 1.62 |
| IR-Endpoint, up to 52 weeks (n=264, 263) | 79.50 ± 1.60 | 80.44 ± 1.62 |
| LF-Baseline (n=264, 263) | 63.19 ± 1.47 | 62.38 ± 1.47 |
| LF-24 weeks (n=254, 258) | 64.18 ± 1.90 | 63.34 ± 1.90 |
| LF-Endpoint, up to 52 weeks (n=264, 263) | 63.25 ± 1.86 | 64.16 ± 1.88 |
| GC-Baseline (n=264, 263) | 64.44 ± 1.34 | 64.34 ± 1.34 |
| GC-24 weeks (n=254, 258) | 72.99 ± 1.62 | 71.73 ± 1.62 |
| GC-Endpoint, up to 52 weeks (n=264, 263) | 70.15 ± 1.67 | 69.24 ± 1.69 |
| HC-Baseline (n=264, 263) | 70.20 ± 1.15 | 70.81 ± 1.15 |
| HC-24 weeks (n=254, 258) | 70.40 ± 1.48 | 71.42 ± 1.48 |
| HC-Endpoint, up to 52 weeks (n=264, 263) | 70.46 ± 1.47 | 71.72 ± 1.49 |
| IDD-Baseline (n=262, 262) | 75.22 ± 1.20 | 76.75 ± 1.20 |
| IDD-24 weeks (n=252, 258) | 79.77 ± 1.42 | 79.36 ± 1.42 |
| IDD-Endpoint, up to 52 weeks (n=262, 262) | 79.46 ± 1.37 | 79.75 ± 1.39 |
| ITSQ Total-Baseline (n=264, 262) | 70.80 ± 0.99 | 71.39 ± 1.00 |
| ITSQ Total-24 weeks (n=253, 258) | 74.46 ± 1.23 | 74.23 ± 1.24 |
| ITSQ Total-Endpoint, up to 52 weeks (n=264, 262) | 73.94 ± 1.25 | 74.48 ± 1.26 |
Total daily insulin dose was adjusted for body weight \[units of insulin/kilogram/day (U/kg/day)\]. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
| U/kg/day | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Endpoint, up to 24 wk-Basal Insulin (n=268, 266) | 0.371 ± 0.011 | 0.358 ± 0.011 |
| Endpoint, up to 24 wk-Bolus Insulin (n=264, 266) | 0.352 ± 0.015 | 0.346 ± 0.016 |
| Endpoint, up to 24 wk-Total Insulin (n=264, 266) | 0.723 ± 0.021 | 0.704 ± 0.021 |
| Endpoint, up to 52 wk-Basal Insulin (n=268, 266) | 0.379 ± 0.012 | 0.361 ± 0.012 |
| Endpoint, up to 52 wk-Bolus Insulin (n=264, 266) | 0.369 ± 0.016 | 0.370 ± 0.016 |
| Endpoint, up to 52 wk-Total Insulin (n=264, 266) | 0.748 ± 0.022 | 0.731 ± 0.022 |
Units of insulin taken daily were presented. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.
| units of insulin per day (U/day) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Endpoint, up to 24 wk-Basal Insulin (n=268, 266) | 27.773 ± 0.970 | 26.049 ± 0.987 |
| Endpoint, up to 24 wk-Bolus Insulin (n=264, 266) | 26.337 ± 1.347 | 25.069 ± 1.362 |
| Endpoint, up to 24 wk-Total Insulin (n=264, 266) | 54.118 ± 1.948 | 51.154 ± 1.970 |
| Endpoint, up to 52 wk-Basal Insulin (n=268, 266) | 28.463 ± 1.073 | 26.404 ± 1.091 |
| Endpoint, up to 52 wk-Bolus Insulin (n=264, 266) | 27.800 ± 1.329 | 27.098 ± 1.344 |
| Endpoint, up to 52 wk-Total Insulin (n=264, 266) | 56.255 ± 2.008 | 53.454 ± 2.031 |
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with Hemoglobin A1c (HbA1c) \<7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (\<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.
| percentage of participants | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| HbA1c- at Baseline <7.0 % (n=267, 267) | 28.8 | 19.5 |
| HbA1c- at Baseline ≤6.5% (n=267, 267) | 13.9 | 12.0 |
| HbA1c- at 6 weeks <7.0% (n=265, 265) | 37.0 | 26.4 |
| HbA1c- at 6 weeks ≤6.5% (n=265, 265) | 21.1 | 14.3 |
| HbA1c- at 12 weeks <7.0% (n=261, 262) | 33.3 | 29.8 |
| HbA1c- at 12 weeks ≤6.5% (n=261, 262) | 19.9 | 15.3 |
| HbA1c- at 24 weeks <7.0% (n=256, 258) | 34.0 | 33.3 |
| HbA1c- at 24 weeks ≤6.5% (n=256, 258) | 19.9 | 19.0 |
| HbA1c- at 36 weeks <7.0% (n=253, 254) | 32.0 | 28.3 |
| HbA1c- at 36 weeks ≤6.5% (n=253, 254) | 15.4 | 18.5 |
| HbA1c- at 52 weeks <7.0% (n=248, 246) | 29.8 | 27.2 |
| HbA1c- at 52 weeks ≤6.5% (n=248, 246) | 15.3 | 14.6 |
| HbA1c- Endpoint, up to 24 weeks <7.0% (n=267, 267) | 34.5 | 32.2 |
| HbA1c- Endpoint, up to 24 weeks ≤6.5% (n=267, 267) | 20.2 | 18.4 |
| HbA1c- Endpoint, up to 52 weeks <7.0% (n=267, 267) | 30.3 | 25.1 |
| HbA1c- Endpoint, up to 52 weeks ≤6.5% (n=267, 267) | 15.7 | 13.5 |
Incidence of hypoglycemic events is defined as the number of hypoglycemic events. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose (BG) concentration of ≤ 70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines \[American Diabetes Association (ADA) 2005\]. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
| events | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Total Events with BG ≤70 mg/dL,if available-24 wk | 10411 | 10976 |
| Total Events with BG ≤70 mg/dL,if available-52-wk | 19541 | 20852 |
| Severe Events-24 wk | 6 | 10 |
| Severe Events-52 wk | 13 | 16 |
| Nocturnal Events with BG ≤70 mg/dL-24 wk | 2217 | 2249 |
| Nocturnal Events with BG ≤70 mg/dL-52 wk | 4105 | 4485 |
The rate of hypoglycemic events per 30 days is defined as the total number of events between visits divided by the actual number of days between visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤ 70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.
| hypoglycemic events per 30 days | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| Total Events with BG ≤70 mg/dL, if available-24 wk | 7.10 ± 6.35 | 7.32 ± 6.58 |
| Severe Events-24 wk | 0.00 ± 0.04 | 0.01 ± 0.04 |
| Nocturnal Events with BG ≤70 mg/dL-24 wk | 1.50 ± 1.93 | 1.51 ± 1.77 |
| Total Events with BG ≤70 mg/dL, if available-52 wk | 6.33 ± 5.64 | 6.56 ± 6.12 |
| Severe Events-52 wk | 0.01 ± 0.04 | 0.01 ± 0.04 |
| Nocturnal Events with BG ≤70 mg/dL-52 wk | 1.32 ± 1.66 | 1.42 ± 1.60 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY2963016 + Insulin Lispro | — | 20/268 (7.5%) | 161/268 (60.1%) |
| Lantus + Insulin Lispro | — | 24/267 (9%) | 158/267 (59.2%) |
| Event | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 13/268 | 12/267 |
| PancytopeniaBlood and lymphatic system disorders | 0/268 | 1/267 |
| Hypertrophic cardiomyopathyCardiac disorders | 0/268 | 1/267 |
| Acute tonsillitisInfections and infestations | 0/268 | 1/267 |
| GastroenteritisInfections and infestations | 0/268 | 1/267 |
| Maternal exposure during pregnancyInjury, poisoning and procedural complications | 0/268 | 1/267 |
| Upper limb fractureInjury, poisoning and procedural complications | 0/268 | 1/267 |
| KetoacidosisMetabolism and nutrition disorders | 0/268 | 1/267 |
| Exostosis of jawMusculoskeletal and connective tissue disorders | 0/268 | 1/267 |
| Gliomatosis cerebriNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/268 | 1/267 |
| Event | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro |
|---|---|---|
| NasopharyngitisInfections and infestations | 43/268 | 45/267 |
| Upper respiratory tract infectionInfections and infestations | 22/268 | 21/267 |
| DiarrhoeaGastrointestinal disorders | 12/268 | 10/267 |
| Back painMusculoskeletal and connective tissue disorders | 10/268 | 9/267 |
| InfluenzaInfections and infestations | 5/268 | 9/267 |
| HypertensionVascular disorders | 9/268 | 5/267 |
| BronchitisInfections and infestations | 4/268 | 8/267 |
| SinusitisInfections and infestations | 7/268 | 8/267 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/268 | 8/267 |
| GastroenteritisInfections and infestations | 8/268 | 7/267 |
All randomized participants who received at least 1 dose of study drug.
| Age, Continuous(years) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro | Total |
|---|---|---|---|
| Mean | 40.96 ± 13.65 | 41.37 ± 13.25 | 41.16 ± 13.44 |
| Sex: Female, Male(Participants) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro | Total |
|---|---|---|---|
| Female | 113 | 112 | 225 |
| Male | 155 | 155 | 310 |
| Ethnicity (NIH/OMB)(Participants) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 10 | 21 |
| Not Hispanic or Latino | 177 | 170 | 347 |
| Unknown or Not Reported | 80 | 87 | 167 |
| Race (NIH/OMB)(Participants) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro | Total |
|---|---|---|---|
| American Indian or Alaska Native | 11 | 12 | 23 |
| Asian | 49 | 51 | 100 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 2 | 11 |
| White | 197 | 201 | 398 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro | Total |
|---|---|---|---|
| United States | 99 | 96 | 195 |
| Hungary | 14 | 16 | 30 |
| Mexico | 17 | 19 | 36 |
| Greece | 15 | 13 | 28 |
| Belgium | 12 | 11 | 23 |
| Poland | 18 | 17 | 35 |
| Romania | 18 | 16 | 34 |
| Germany | 26 | 28 | 54 |
| Japan | 49 | 51 | 100 |
| Baseline Hemoglobin A1c (HbA1c)(percentage of glycosylated hemoglobin) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro | Total |
|---|---|---|---|
| Mean | 7.75 ± 1.13 | 7.79 ± 1.03 | 7.77 ± 1.08 |
| Time of Basal Insulin Injection(participants) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro | Total |
|---|---|---|---|
| Daytime | 51 | 48 | 99 |
| Evening/Bedtime | 217 | 219 | 436 |
| Body Weight(kilograms (kg)) | LY2963016 + Insulin Lispro | Lantus + Insulin Lispro | Total |
|---|---|---|---|
| Mean | 75.80 ± 16.76 | 74.77 ± 15.36 | 75.29 ± 16.07 |
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