A Phase 3 interventional study of Glargine and LY2605541 in Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company. Completed at 51 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this study is:
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Have been treated for at least 90 days prior to screening with the following:
This inclusion criterion applies to female participants:
Exclusion Criteria:
Lipid-lowering medications:
Hepatic: Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements as indicated below:
LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Drug: LY2605541 · Drug: Insulin Lispro
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Drug: Glargine · Drug: Insulin Lispro
Administered by SC injection via a pen device.
Administered by SC injection with a pen device.
Administered by SC injection with a pen device.
Also known as: LY275585, Humalog
Hemoglobin A1c (HbA1c) at 26 Weeks
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM), adjusting for treatment, stratification factors (baseline low-density lipoprotein cholesterol \[LDL-C\] \[\<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
Time frame: 26 weeks
Hemoglobin A1c (HbA1c)
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
Time frame: 52 weeks and 78 weeks
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Percentage of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% or Less Than or Equal to 6.5% Using Last Observation Carried Forward (LOCF)
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, then multiplying by 100.
Time frame: 26 weeks and 52 weeks and 78 weeks
Proportion of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% Without Nocturnal Hypoglycemia
Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 millimoles per liter \[mmol/L\]). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c \<7.0% without nocturnal hypoglycemia by the total number of participants analyzed, then multiplying by 100.
Time frame: 26 weeks and 52 weeks and 78 weeks
Total Hypoglycemia Rates (Adjusted by 30 Days)
Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log \[exposure in days/30\] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Time frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Percentage of Participants With Total Hypoglycemia Events
Hypoglycemic events are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.
Time frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Nocturnal Hypoglycemia Rates (Adjusted by 30 Days)
Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log \[exposure in days/30\] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Time frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Percentage of Participants With Nocturnal Hypoglycemic Events
Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.
Time frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Fasting Serum Glucose (FSG) by Laboratory Measurement
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
Time frame: 26 weeks and 52 weeks and 78 weeks
Fasting Blood Glucose (FBG) Intra-participant Variability
FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
Time frame: 26 weeks and 52 weeks and 78 weeks
0300-hour Blood Glucose (BG) to Fasting Blood (FBG) Glucose Excursion
Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Time frame: 26 weeks and 52 weeks and 78 weeks
9 Point Self-monitored Blood Glucose (SMBG)
9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, 52, 65, and 78. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the pre-morning meal the next day. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Time frame: 26 weeks and 52 weeks and 78 weeks
Change From Baseline in Body Weight
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
Time frame: Baseline and 26 weeks and 52 weeks and 78 weeks
Basal, Bolus, and Total Insulin Dose
Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Time frame: 26 weeks and 52 weeks and 78 weeks
Lipid Profile
Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM, adjusting for stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], country, LDL-C \[\<100 mg/dL and ≥100 mg/dL\] except for the LDL-C outcome variable), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable.
Time frame: 26 weeks and 52 weeks and 78 weeks
Percentage of Participants With Change in Anti-LY2605541 Antibodies
The percentage of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable or from detectable to the value with at least 130% relative increase from baseline.
Time frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 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. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification (baseline HbA1c \[≤8.5% or \>8.5%\] and country) as fixed effects and baseline value of the dependent variable as a covariate.
Time frame: 26 weeks
Low Blood Sugar Survey (LBSS)
LBSS (also referenced as Hypoglycemia Fear Survey - II \[HFS-II\]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\] and country), visit, treatment-by-visit interaction , and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Time frame: 26 weeks and 52 weeks and 78 weeks
European Quality of Life-5 Dimension (EQ-5D)
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using ANCOVA, adjusting for treatment and stratification factors (baseline HbA1c \[≤8.5% or \>8.5%\] and country) as fixed effects and baseline EQ-5D score as a covariate.
Time frame: 26 weeks
Rapid Assessment of Physical Activity (RAPA)
The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant's amount and intensity of physical activity, allowing each participant's aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants' physical activities that increase strength and improve flexibility. Each participant's strength and flexibility activity level is then categorized as neither strength nor flexibility (flex) activity, either strength or flex (not both), both strength and flex activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, then multiplying by 100.
Time frame: 26 weeks and 78 weeks
| Milestone | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Started | 295 | 160 |
| Received at least 1 dose of study drug | 294 | 159 |
| Completed | 225 | 132 |
| Not completed | 70 | 28 |
| Withdrew: Adverse event | 23 | 5 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Protocol violation | 2 | 3 |
| Withdrew: Withdrawal by subject | 26 | 13 |
| Withdrew: Physician decision | 13 | 4 |
| Withdrew: Sponsor decision | 3 | 1 |
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM), adjusting for treatment, stratification factors (baseline low-density lipoprotein cholesterol \[LDL-C\] \[\<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
| percentage of HbA1c | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Hemoglobin A1c (HbA1c) at 26 Weeks | 7.06 ± 0.04 | 7.43 ± 0.06 |
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
| percentage of HbA1c | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Week 52 | 7.30 ± 0.05 | 7.55 ± 0.06 |
| Week 78 | 7.43 ± 0.05 | 7.70 ± 0.07 |
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
| percentage of HbA1c | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Week 26 | -0.69 ± 0.04 | -0.33 ± 0.06 |
| Week 56 | -0.46 ± 0.05 | -0.21 ± 0.06 |
| Week 78 | -0.33 ± 0.05 | -0.05 ± 0.07 |
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, then multiplying by 100.
| percentage of participants | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| HbA1c ≤6.5%, Week 26 | 28.6 | 13.7 |
| HbA1c ≤6.5%, Week 52 | 23.3 | 13.1 |
| HbA1c ≤6.5%, Week 78 | 20.2 | 13.1 |
| HbA1c <7.0%, Week 26 | 44.9 | 27.5 |
| HbA1c <7.0%, Week 52 | 37.3 | 28.1 |
| HbA1c <7.0%, Week 78 | 34.5 | 22.9 |
Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 millimoles per liter \[mmol/L\]). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c \<7.0% without nocturnal hypoglycemia by the total number of participants analyzed, then multiplying by 100.
| percentage of participants | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Week 26 | 3.8 | 2.0 |
| Week 52 | 2.1 | 0.7 |
| Week 78 | 1.0 | 0.0 |
Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log \[exposure in days/30\] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
| episodes/participant/30 days | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Baseline-Week 26 | 16.01 ± 0.44 | 12.43 ± 0.55 |
| Baseline-Week 52 | 14.84 ± 0.42 | 11.75 ± 0.55 |
| Baseline-Week 78 | 14.33 ± 0.42 | 11.43 ± 0.55 |
Hypoglycemic events are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.
| percentage of participants | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Baseline-Week 26 | 99.0 | 96.9 |
| Baseline-Week 52 | 99.0 | 96.9 |
| Baseline-Week 78 | 99.0 | 96.9 |
Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log \[exposure in days/30\] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
| episodes/participant/30 days | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Baseline-Week 26 | 1.69 ± 0.12 | 2.66 ± 0.19 |
| Baseline-Week 52 | 1.63 ± 0.11 | 2.45 ± 0.19 |
| Baseline-Week 78 | 1.58 ± 0.11 | 2.28 ± 0.17 |
Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.
| percentage of participants | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Baseline-Week 26 | 87.4 | 90.6 |
| Baseline-Week 52 | 91.5 | 91.8 |
| Baseline-Week 78 | 93.5 | 92.5 |
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
| mg/dL | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Week 26 | 138.22 ± 3.80 | 160.35 ± 5.06 |
| Week 52 | 146.55 ± 4.42 | 164.28 ± 5.72 |
| Week 78 | 144.64 ± 4.53 | 164.78 ± 5.81 |
FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
| mg/dL | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Week 26 | 52.49 ± 1.79 | 59.25 ± 2.43 |
| Week 52 | 53.44 ± 1.85 | 58.15 ± 2.43 |
| Week 78 | 54.87 ± 2.20 | 60.66 ± 2.79 |
Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
| mg/dL | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Week 26 | -9.92 ± 6.24 | -14.08 ± 8.75 |
| Week 52 | -6.15 ± 6.91 | -9.02 ± 9.58 |
| Week 78 | -10.82 ± 8.25 | -28.94 ± 10.50 |
9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, 52, 65, and 78. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the pre-morning meal the next day. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
| mg/dL | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Pre-morning meal, Week 26 | 158.58 ± 3.82 | 144.40 ± 5.20 |
| Pre-morning meal, Week 52 | 160.89 ± 4.13 | 152.55 ± 5.38 |
| Pre-morning meal, Week 78 | 163.09 ± 4.66 | 153.38 ± 5.99 |
| 2 hours post-morning meal, Week 26 | 172.39 ± 4.59 | 165.53 ± 6.44 |
| 2 hours post-morning meal, Week 52 | 176.32 ± 5.61 | 168.38 ± 7.47 |
| 2 hours post-morning meal, Week 78 | 183.64 ± 6.23 | 190.54 ± 7.91 |
| Pre-midday meal, Week 26 | 136.21 ± 3.92 | 153.12 ± 5.33 |
| Pre-midday meal, Week 52 | 142.82 ± 4.27 | 149.78 ± 5.66 |
| Pre-midday meal, Week 78 | 150.83 ± 4.90 | 154.56 ± 6.33 |
| 2 hours post-midday meal, Week 26 | 157.17 ± 4.78 | 164.75 ± 6.69 |
| 2 hours post-midday meal, Week 52 | 159.59 ± 5.11 | 168.83 ± 6.94 |
| 2 hours post-midday meal, Week 78 | 154.46 ± 5.76 | 175.52 ± 7.51 |
| Pre-evening meal, Week 26 | 153.20 ± 4.29 | 168.08 ± 5.75 |
| Pre-evening meal, Week 52 | 153.01 ± 5.17 | 183.18 ± 6.81 |
| Pre-evening meal, Week 78 | 149.89 ± 4.92 | 174.50 ± 6.17 |
| 2 hours post-evening meal, Week 26 | 149.74 ± 5.17 | 191.99 ± 7.20 |
| 2 hours post-evening meal, Week 52 | 157.81 ± 6.79 | 198.10 ± 9.06 |
| 2 hours post-evening meal, Week 78 | 163.27 ± 6.07 | 189.43 ± 7.75 |
| Bedtime, Week 26 | 151.66 ± 4.15 | 176.17 ± 5.63 |
| Bedtime, Week 52 | 167.35 ± 5.33 | 182.08 ± 7.11 |
| Bedtime, Week 78 | 165.63 ± 5.37 | 185.45 ± 6.74 |
| 0300 hours, Week 26 | 159.73 ± 5.30 | 163.18 ± 7.50 |
| 0300 hours, Week 52 | 157.52 ± 6.06 | 148.26 ± 8.36 |
| 0300 hours, Week 78 | 165.82 ± 7.19 | 170.35 ± 9.02 |
| Pre-morning meal next day, Week 26 | 149.94 ± 3.74 | 143.89 ± 5.10 |
| Pre-morning meal next day, Week 52 | 155.79 ± 4.24 | 145.55 ± 5.59 |
| Pre-morning meal next day, Week 78 | 156.87 ± 4.80 | 152.63 ± 6.11 |
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
| kilograms (kg) | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Week 26 | -1.17 ± 0.20 | 0.71 ± 0.27 |
| Week 52 | -1.22 ± 0.25 | 1.00 ± 0.33 |
| Week 78 | -0.93 ± 0.28 | 1.04 ± 0.37 |
Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C level \[\<100 mg/dL and ≥100 mg/dL\], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
| units/kg/day | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Basal Insulin, Week 26 | 0.40 ± 0.01 | 0.34 ± 0.01 |
| Basal Insulin, Week 52 | 0.40 ± 0.01 | 0.34 ± 0.01 |
| Basal Insulin, Week 78 | 0.41 ± 0.01 | 0.35 ± 0.01 |
| Bolus Insulin, Week 26 | 0.37 ± 0.01 | 0.46 ± 0.02 |
| Bolus Insulin, Week 52 | 0.38 ± 0.01 | 0.47 ± 0.02 |
| Bolus Insulin, Week 78 | 0.37 ± 0.02 | 0.48 ± 0.02 |
| Total Insulin, Week 26 | 0.73 ± 0.02 | 0.78 ± 0.02 |
| Total Insulin, Week 52 | 0.74 ± 0.02 | 0.79 ± 0.03 |
| Total Insulin, Week 78 | 0.75 ± 0.02 | 0.80 ± 0.03 |
Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM, adjusting for stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], country, LDL-C \[\<100 mg/dL and ≥100 mg/dL\] except for the LDL-C outcome variable), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable.
| mg/dL | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Cholesterol, Week 26 | 191.86 ± 1.63 | 187.93 ± 2.19 |
| Cholesterol, Week 52 | 190.72 ± 1.59 | 188.65 ± 2.10 |
| Cholesterol, Week 78 | 191.78 ± 1.86 | 190.06 ± 2.39 |
| HDL-C, Week 26 | 61.87 ± 0.59 | 62.75 ± 0.80 |
| HDL-C, Week 52 | 61.01 ± 0.56 | 61.46 ± 0.74 |
| HDL-C, Week 78 | 60.77 ± 0.66 | 61.97 ± 0.85 |
| LDL-C, Week 26 | 108.85 ± 1.33 | 108.31 ± 1.79 |
| LDL-C, Week 52 | 109.40 ± 1.39 | 109.74 ± 1.84 |
| LDL-C, Week 78 | 109.62 ± 1.62 | 110.35 ± 2.09 |
| Triglycerides, Week 26 | 109.64 ± 3.89 | 85.35 ± 5.24 |
| Triglycerides, Week 52 | 105.17 ± 3.64 | 87.94 ± 4.80 |
| Triglycerides, Week 78 | 110.80 ± 4.78 | 88.96 ± 6.14 |
The percentage of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable or from detectable to the value with at least 130% relative increase from baseline.
| percentage of participants | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Week 26 | 30.6 | 15.8 |
| Week 52 | 29.9 | 17.1 |
| Week 78 | 26.4 | 13.1 |
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification (baseline HbA1c \[≤8.5% or \>8.5%\] and country) as fixed effects and baseline value of the dependent variable as a covariate.
| units on a scale | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Insulin Treatment Satisfaction Questionnaire (ITSQ) | 72.43 ± 0.69 | 73.91 ± 0.94 |
LBSS (also referenced as Hypoglycemia Fear Survey - II \[HFS-II\]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\] and country), visit, treatment-by-visit interaction , and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
| units on a scale | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| Week 26 | 28.09 ± 0.70 | 27.09 ± 0.95 |
| Week 52 | 27.76 ± 0.77 | 27.00 ± 1.01 |
| Week 78 | 27.68 ± 0.91 | 27.14 ± 1.18 |
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using ANCOVA, adjusting for treatment and stratification factors (baseline HbA1c \[≤8.5% or \>8.5%\] and country) as fixed effects and baseline EQ-5D score as a covariate.
| units on a scale | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| European Quality of Life-5 Dimension (EQ-5D) | 0.92 ± 0.01 | 0.91 ± 0.01 |
The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant's amount and intensity of physical activity, allowing each participant's aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants' physical activities that increase strength and improve flexibility. Each participant's strength and flexibility activity level is then categorized as neither strength nor flexibility (flex) activity, either strength or flex (not both), both strength and flex activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, then multiplying by 100.
| percentage of participants | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| RAPA 1, Sedentary, Week 26 | 1.0 | 0.0 |
| RAPA 1, Sedentary, Week 78 | 1.3 | 0.0 |
| RAPA 1, Underactive, Week 26 | 3.1 | 3.5 |
| RAPA 1, Underactive, Week 78 | 3.8 | 2.0 |
| RAPA 1, Light activity, Week 26 | 13.3 | 10.5 |
| RAPA 1, Light activity, Week 78 | 7.5 | 13.7 |
| RAPA 1, Regular underactive, Week 26 | 24.5 | 29.8 |
| RAPA 1, Regular underactive, Week 78 | 31.3 | 29.4 |
| RAPA 1, Active, Week 26 | 58.2 | 56.1 |
| RAPA 1, Active, Week 78 | 56.3 | 54.9 |
| RAPA 2, Neither strength/flex, Week 26 | 35.7 | 43.9 |
| RAPA 2, Neither strength/flex, Week 78 | 37.0 | 47.1 |
| RAPA 2, Either strength/flex, Week 26 | 30.6 | 35.1 |
| RAPA 2, Either strength/flex, Week 78 | 33.3 | 29.4 |
| RAPA 2, Both strength/flex, Week 26 | 33.7 | 21.1 |
| RAPA 2, Both strength/flex, Week 78 | 29.6 | 23.5 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY2605541 + Insulin Lispro | — | 67/294 (22.8%) | 256/294 (87.1%) |
| Glargine + Insulin Lispro | — | 25/159 (15.7%) | 112/159 (70.4%) |
| Event | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 45/294 | 13/159 |
| Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/157 | 0/73 |
| Atrial fibrillationCardiac disorders | 3/294 | 1/159 |
| PancreatitisGastrointestinal disorders | 2/294 | 0/159 |
| GastroenteritisInfections and infestations | 2/294 | 0/159 |
| OsteomyelitisInfections and infestations | 2/294 | 1/159 |
| Skin ulcerSkin and subcutaneous tissue disorders | 2/294 | 0/159 |
| Cervix carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/157 | 0/73 |
| Cervical polypReproductive system and breast disorders | 1/157 | 0/73 |
| MenorrhagiaReproductive system and breast disorders | 1/157 | 0/73 |
| Event | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro |
|---|---|---|
| NasopharyngitisInfections and infestations | 92/294 | 38/159 |
| LipohypertrophySkin and subcutaneous tissue disorders | 45/294 | 0/159 |
| InfluenzaInfections and infestations | 25/294 | 14/159 |
| Upper respiratory tract infectionInfections and infestations | 13/294 | 12/159 |
| HeadacheNervous system disorders | 18/294 | 10/159 |
| Lipodystrophy acquiredSkin and subcutaneous tissue disorders | 17/294 | 1/159 |
| Urinary tract infectionInfections and infestations | 15/294 | 8/159 |
| Back painMusculoskeletal and connective tissue disorders | 15/294 | 7/159 |
| GastroenteritisInfections and infestations | 11/294 | 8/159 |
| DiarrhoeaGastrointestinal disorders | 13/294 | 3/159 |
All randomized participants.
| Age, Continuous(years) | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro | Total |
|---|---|---|---|
| Mean | 39.68 ± 12.93 | 38.91 ± 14.10 | 39.41 ± 13.34 |
| Sex: Female, Male(Participants) | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro | Total |
|---|---|---|---|
| Female | 157 | 73 | 230 |
| Male | 138 | 87 | 225 |
| Ethnicity (NIH/OMB)(Participants) | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro | Total |
|---|---|---|---|
| Hispanic or Latino | 33 | 16 | 49 |
| Not Hispanic or Latino | 153 | 85 | 238 |
| Unknown or Not Reported | 109 | 59 | 168 |
| Race (NIH/OMB)(Participants) | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro | Total |
|---|---|---|---|
| American Indian or Alaska Native | 6 | 3 | 9 |
| Asian | 63 | 31 | 94 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 0 | 5 |
| White | 221 | 125 | 346 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | LY2605541 + Insulin Lispro | Glargine + Insulin Lispro | Total |
|---|---|---|---|
| France | 23 | 14 | 37 |
| United States | 85 | 45 | 130 |
| Mexico | 25 | 15 | 40 |
| Poland | 27 | 14 | 41 |
| Austria | 7 | 4 | 11 |
| Russia | 11 | 9 | 20 |
| Germany | 45 | 21 | 66 |
| Japan | 60 | 31 | 91 |
| Italy | 12 | 7 | 19 |
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: LY2605541