A Phase 3 interventional study of LY2605541 and Insulin glargine in Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Completed at 61 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks:
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Exclusion Criteria:
Lipid-lowering medication: Are using or have used any of the following:
Administered by subcutaneous (SQ) injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications (OAMs) whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.
Drug: LY2605541
Administered by SQ injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG. Insulin glargine will be used alone or in combination with up to 3 pre-study OAMs whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.
Drug: Insulin glargine
Also known as: Insulin peglispro
Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)
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 stratification factors (country, baseline low-density lipoprotein cholesterol \[LDL-C, \<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Time frame: Baseline, 26 weeks
Change From Baseline to 52 Weeks in HbA1c
LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Time frame: Baseline, 52 weeks
Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)
Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter \[mmol/L\]). A nocturnal hypoglycemic event occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline hypoglycemia rate + baseline SU or meglitinide use, 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
Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events
Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.
Time frame: Baseline through 26 weeks and Baseline through 52 weeks
Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Time frame: 26 and 52 weeks
Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. 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, multiplied by 100.
Time frame: 26 and 52 weeks
Fasting Serum Glucose (FSG) (by Laboratory)
LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \[≤8.0% and \>8.0%\], baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FSG.
Time frame: 26 and 52 weeks
Fasting Blood Glucose (FBG) (by Self Monitoring)
LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \[≤8.0% and \>8.0%\], baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FBG.
Time frame: 26 and 52 weeks
Intra-participant Variability in Fasting Blood Glucose (FBG)
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 the stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline FBG intra-participant variability.
Time frame: 26 and 52 weeks
6-point Self-monitored Blood Glucose (SMBG)
SMBG measurements were taken at 6 time points (pre-morning meal \[fasting\], pre-midday meal, pre-evening meal, bedtime, approximately 0300 hours, and pre-morning meal \[fasting\] on the next day) and were performed on 2 non-consecutive days in the week prior to next office visit. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], country, LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline BG values.
Time frame: 26 and 52 weeks
HbA1c
LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Time frame: 26 and 52 weeks
Insulin Dose Per Kilogram of Body Weight
Daily basal insulin dose is presented. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline insulin dose.
Time frame: 26 and 52 weeks
Number of Insulin Dose Adjustments to Steady-state
The number of dose adjustments required to reach a steady dose is presented. LS means were calculated from negative binomial regression models, where the number of dose adjustments = treatment + stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use).
Time frame: Baseline through 26 weeks
European Quality of Life - 5 Dimension (EuroQol-5D) Score
The EuroQol-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 an analysis of covariance (ANCOVA) model adjusting for treatment, stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], and SU or meglitinide use), and baseline EuroQol-5D score.
Time frame: 26 weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
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, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], and SU or meglitinide use) as fixed effects and baseline value of the ITSQ score as a covariate.
Time frame: 26 weeks
Adult Low Blood Sugar Survey (LBSS) Score
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 ANCOVA with treatment and stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], and SU or meglitinide use) as fixed effects and baseline value of the LBSS score as a covariate.
Time frame: 26 weeks
Change From Baseline in Body Weight
LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], LDL-C \[\<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline body weight.
Time frame: Baseline, 26 weeks, 52 weeks
Change From Baseline in 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 (country, baseline HbA1c \[≤8.5% and \>8.5%\], LDL-C \[\<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.
Time frame: Baseline, 26 weeks, 52 weeks
Number of Participants With Change in Anti-LY2605541 Antibodies
The number 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 52 weeks
| Milestone | LY2605541 | Insulin Glargine |
|---|---|---|
| Started | 307 | 159 |
| Received at least 1 dose of study drug | 305 | 159 |
| Completed | 275 | 139 |
| Not completed | 32 | 20 |
| Withdrew: Adverse event | 1 | 3 |
| Withdrew: Death | 3 | 3 |
| Withdrew: Lost to follow-up | 0 | 2 |
| Withdrew: Protocol violation | 11 | 3 |
| Withdrew: Withdrawal by subject | 13 | 9 |
| Withdrew: Physician decision | 3 | 0 |
| Withdrew: Sponsor decision | 1 | 0 |
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 stratification factors (country, baseline low-density lipoprotein cholesterol \[LDL-C, \<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
| percentage of HbA1c | LY2605541 | Insulin Glargine |
|---|---|---|
| Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c) | -0.82 ± 0.04 | -0.29 ± 0.06 |
LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
| percentage of HbA1c | LY2605541 | Insulin Glargine |
|---|---|---|
| Change From Baseline to 52 Weeks in HbA1c | -0.67 ± 0.05 | -0.22 ± 0.06 |
Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter \[mmol/L\]). A nocturnal hypoglycemic event occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline hypoglycemia rate + baseline SU or meglitinide use, 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.
| events/participant/30 days | LY2605541 | Insulin Glargine |
|---|---|---|
| Total hypoglycemia, 0-26 weeks | 1.55 ± 0.13 | 1.98 ± 0.19 |
| Total hypoglycemia, 0-52 weeks | 1.24 ± 0.10 | 1.62 ± 0.15 |
| Nocturnal hypoglycemia, 0-26 weeks | 0.43 ± 0.06 | 1.04 ± 0.15 |
| Nocturnal hypoglycemia, 0-52 weeks | 0.35 ± 0.06 | 0.88 ± 0.14 |
Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.
| percentage of participants | LY2605541 | Insulin Glargine |
|---|---|---|
| Total hypoglycemia, 0-26 weeks | 76.3 | 80.5 |
| Total hypoglycemia, 0-52 weeks | 80.3 | 83.0 |
| Nocturnal hypoglycemia, 0-26 weeks | 46.1 | 62.3 |
| Nocturnal hypoglycemia, 0-52 weeks | 50.3 | 67.3 |
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
| percentage of participants | LY2605541 | Insulin Glargine |
|---|---|---|
| HbA1c ≤6.5%, 26 weeks | 50.3 | 28.7 |
| HbA1c ≤6.5%, 52 weeks | 43.4 | 28.0 |
| HbA1c <7.0%, 26 weeks | 72.5 | 52.2 |
| HbA1c <7.0%, 52 weeks | 63.9 | 45.9 |
Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. 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, multiplied by 100.
| percentage of participants | LY2605541 | Insulin Glargine |
|---|---|---|
| 26 weeks | 40.1 | 18.5 |
| 52 weeks | 34.8 | 10.2 |
LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \[≤8.0% and \>8.0%\], baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FSG.
| milligrams per deciliter (mg/dL) | LY2605541 | Insulin Glargine |
|---|---|---|
| 26 weeks | 103.80 ± 1.88 | 119.50 ± 2.64 |
| 52 weeks | 107.61 ± 1.94 | 115.74 ± 2.72 |
LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \[≤8.0% and \>8.0%\], baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FBG.
| milligrams per deciliter (mg/dL) | LY2605541 | Insulin Glargine |
|---|---|---|
| 26 weeks | 106.32 ± 1.08 | 104.50 ± 1.51 |
| 52 weeks | 110.61 ± 1.19 | 107.46 ± 1.68 |
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 the stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline FBG intra-participant variability.
| mg/dL | LY2605541 | Insulin Glargine |
|---|---|---|
| 26 weeks | 13.70 ± 0.57 | 17.90 ± 0.80 |
| 52 weeks | 14.18 ± 0.65 | 17.38 ± 0.91 |
SMBG measurements were taken at 6 time points (pre-morning meal \[fasting\], pre-midday meal, pre-evening meal, bedtime, approximately 0300 hours, and pre-morning meal \[fasting\] on the next day) and were performed on 2 non-consecutive days in the week prior to next office visit. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], country, LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline BG values.
| mg/dL | LY2605541 | Insulin Glargine |
|---|---|---|
| Pre-morning meal, 26 weeks | 107.93 ± 1.30 | 104.11 ± 1.83 |
| Pre-midday meal, 26 weeks | 120.87 ± 2.20 | 132.56 ± 3.11 |
| Pre-evening meal, 26 weeks | 125.87 ± 2.18 | 141.45 ± 3.08 |
| Bedtime, 26 weeks | 146.54 ± 2.61 | 161.48 ± 3.69 |
| 0300 hours, 26 weeks | 118.43 ± 2.04 | 120.42 ± 2.87 |
| Pre-morning meal next day, 26 weeks | 106.28 ± 1.36 | 102.79 ± 1.90 |
| Pre-morning meal, 52 weeks | 110.84 ± 1.39 | 108.22 ± 1.94 |
| Pre-midday meal, 52 weeks | 121.34 ± 2.17 | 130.55 ± 3.06 |
| Pre-evening meal, 52 weeks | 128.53 ± 2.00 | 141.31 ± 2.82 |
| Bedtime, 52 weeks | 146.92 ± 2.37 | 161.83 ± 3.34 |
| 0300 hours, 52 weeks | 122.23 ± 1.96 | 121.07 ± 2.76 |
| Pre-morning meal next day, 52 weeks | 110.38 ± 1.41 | 106.68 ± 1.97 |
LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
| percentage of HbA1c | LY2605541 | Insulin Glargine |
|---|---|---|
| 26 weeks | 6.60 ± 0.04 | 7.13 ± 0.06 |
| 52 weeks | 6.75 ± 0.05 | 7.20 ± 0.06 |
Daily basal insulin dose is presented. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline insulin dose.
| units per kilogram per day (U/kg/day) | LY2605541 | Insulin Glargine |
|---|---|---|
| 26 weeks | 0.57 ± 0.01 | 0.49 ± 0.01 |
| 52 weeks | 0.58 ± 0.01 | 0.49 ± 0.02 |
The number of dose adjustments required to reach a steady dose is presented. LS means were calculated from negative binomial regression models, where the number of dose adjustments = treatment + stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and SU or meglitinide use).
| number of dose adjustments | LY2605541 | Insulin Glargine |
|---|---|---|
| Number of Insulin Dose Adjustments to Steady-state | 4.06 ± 0.16 | 2.75 ± 0.20 |
The EuroQol-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 an analysis of covariance (ANCOVA) model adjusting for treatment, stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], and SU or meglitinide use), and baseline EuroQol-5D score.
| units on a scale | LY2605541 | Insulin Glargine |
|---|---|---|
| European Quality of Life - 5 Dimension (EuroQol-5D) Score | 0.87 ± 0.01 | 0.88 ± 0.01 |
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, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], and SU or meglitinide use) as fixed effects and baseline value of the ITSQ score as a covariate.
| units on a scale | LY2605541 | Insulin Glargine |
|---|---|---|
| Insulin Treatment Satisfaction Questionnaire (ITSQ) Score | 85.69 ± 0.63 | 84.43 ± 0.89 |
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 ANCOVA with treatment and stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], and SU or meglitinide use) as fixed effects and baseline value of the LBSS score as a covariate.
| units on a scale | LY2605541 | Insulin Glargine |
|---|---|---|
| Adult Low Blood Sugar Survey (LBSS) Score | 16.57 ± 0.77 | 15.63 ± 1.08 |
LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c \[≤8.5% and \>8.5%\], LDL-C \[\<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline body weight.
| kilograms (kg) | LY2605541 | Insulin Glargine |
|---|---|---|
| 26 weeks | 0.50 ± 0.17 | 0.94 ± 0.24 |
| 52 weeks | 0.69 ± 0.23 | 1.32 ± 0.32 |
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 (country, baseline HbA1c \[≤8.5% and \>8.5%\], LDL-C \[\<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable\], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.
| mg/dL | LY2605541 | Insulin Glargine |
|---|---|---|
| Cholesterol, 26 weeks | 2.24 ± 1.60 | 3.70 ± 2.25 |
| Cholesterol, 52 weeks | -1.35 ± 1.63 | 2.78 ± 2.29 |
| HDL-C, 26 weeks | -1.74 ± 0.37 | -0.06 ± 0.52 |
| HDL-C, 52 weeks | -3.52 ± 0.37 | -2.01 ± 0.51 |
| LDL-C, 26 weeks | -0.05 ± 1.43 | 4.54 ± 2.00 |
| LDL-C, 52 weeks | -3.38 ± 1.45 | 3.41 ± 2.03 |
| Triglycerides, 26 weeks | 22.53 ± 3.73 | -2.90 ± 5.23 |
| Triglycerides, 52 week | 27.39 ± 4.00 | 12.02 ± 5.59 |
The number 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.
| participants | LY2605541 | Insulin Glargine |
|---|---|---|
| Number of Participants With Change in Anti-LY2605541 Antibodies | 70 | 30 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY2605541 | — | 36/305 (11.8%) | 223/305 (73.1%) |
| Insulin Glargine | — | 22/159 (13.8%) | 104/159 (65.4%) |
| Event | LY2605541 | Insulin Glargine |
|---|---|---|
| Ovarian cystReproductive system and breast disorders | 0/131 | 1/66 |
| Acute coronary syndromeCardiac disorders | 0/305 | 2/159 |
| Acute myocardial infarctionCardiac disorders | 2/305 | 2/159 |
| Atrial fibrillationCardiac disorders | 0/305 | 2/159 |
| Cardiac failure congestiveCardiac disorders | 0/305 | 2/159 |
| Coronary artery diseaseCardiac disorders | 1/305 | 2/159 |
| Myocardial infarctionCardiac disorders | 0/305 | 2/159 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/305 | 2/159 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/174 | 1/93 |
| Endometrial adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/131 | 0/66 |
| Event | LY2605541 | Insulin Glargine |
|---|---|---|
| NasopharyngitisInfections and infestations | 50/305 | 27/159 |
| HeadacheNervous system disorders | 15/305 | 12/159 |
| InfluenzaInfections and infestations | 13/305 | 11/159 |
| Back painMusculoskeletal and connective tissue disorders | 21/305 | 9/159 |
| DiarrhoeaGastrointestinal disorders | 19/305 | 6/159 |
| SinusitisInfections and infestations | 18/305 | 9/159 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 7/305 | 9/159 |
| CoughRespiratory, thoracic and mediastinal disorders | 16/305 | 9/159 |
| Upper respiratory tract infectionInfections and infestations | 16/305 | 8/159 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 15/305 | 7/159 |
All randomized participants.
| Age, Continuous(years) | LY2605541 | Insulin Glargine | Total |
|---|---|---|---|
| Mean | 61.84 ± 8.52 | 60.38 ± 10.10 | 61.34 ± 9.11 |
| Sex: Female, Male(Participants) | LY2605541 | Insulin Glargine | Total |
|---|---|---|---|
| Female | 132 | 66 | 198 |
| Male | 175 | 93 | 268 |
| Ethnicity (NIH/OMB)(Participants) | LY2605541 | Insulin Glargine | Total |
|---|---|---|---|
| Hispanic or Latino | 57 | 25 | 82 |
| Not Hispanic or Latino | 215 | 115 | 330 |
| Unknown or Not Reported | 35 | 19 | 54 |
| Race (NIH/OMB)(Participants) | LY2605541 | Insulin Glargine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 4 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 17 | 9 | 26 |
| White | 280 | 148 | 428 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(Participants) | LY2605541 | Insulin Glargine | Total |
|---|---|---|---|
| United States | 170 | 85 | 255 |
| Czechia | 20 | 10 | 30 |
| Greece | 16 | 5 | 21 |
| Spain | 27 | 12 | 39 |
| Romania | 16 | 14 | 30 |
| Israel | 16 | 8 | 24 |
| Russia | 17 | 9 | 26 |
| Germany | 25 | 16 | 41 |
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