A Phase 3 interventional study of Glargine and LY2605541 in Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Completed at 167 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-13.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this study is:
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 1,538 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks
Drug: LY2605541
Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
Drug: Glargine
Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)
HbA1C is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol \[LDL-C, \< 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL\] and sulfonylurea \[SU\]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects.
Time frame: Baseline, 52 weeks
Rate of Total and Nocturnal Hypoglycemia Events
Hypoglycemia is a condition that occurs when a person's blood glucose level is lower than the normal range (less than or equal to 70 milligrams per deciliter \[mg/dL\] or less than 3.9 millimoles per liter \[mmol/L\]). Total hypoglycemia refers to an event that meets the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemia refers to any total hypoglycemic event that occurs between bedtime and waking. Group mean (listed as LS means below) rates of total and nocturnal hypoglycemia were calculated using a negative binomial regression model (number of episodes = treatment + SU/meglitinide use + baseline hypoglycemia event rate, with log \[exposure per 30 days\] as the offset variable in the model).
Time frame: Baseline to 52 weeks
Percentage of Participants With Hemoglobin A1c Equal 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: 52 weeks
Fasting Serum Glucose (By Laboratory Measurement)
LS means were calculated using a MMRM with baseline fasting serum glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: 52 weeks
Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)
LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: 52 weeks
6 Point Self-monitored Blood Glucose (SMBG)
Six-point SMBG profiles were obtained at pre-morning meal (fasting), pre-midday meal (lunch), pre-evening meal (dinner), bedtime, approximately 0300 hours, and pre-morning meal (fasting) the next day. Six-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to the next office visit. LS means were calculated using a MMRM with baseline blood glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: 52 weeks
Change From Baseline to 52 Weeks in Body Weight
LS means were calculated using a MMRM with baseline body weight measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: Baseline, 52 weeks
Hemoglobin A1c
HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: 52 weeks
Insulin Dose Per Body Weight
LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: 52 weeks
Number of Insulin Dose Adjustments to Steady-State
Insulin doses were adjusted according to an algorithm (adapted from Riddle et al. 2003) during the first 26 weeks of the study and thereafter according to investigator judgment. Steady-state was defined as the first local maximum dose (maximum of moving 4-week interval) of LY2605541 or glargine within the window of +/- 2 weeks. The number of dose adjustments to steady-state was the total number of dose changes until steady-state was reached. LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: Baseline to 52 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 to 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 a MMRM with baseline stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: 52 weeks
Insulin Treatment Satisfaction Questionnaire
The Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes who are receiving 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 total score on a scale of 0 to 100, where higher scores indicate better treatment satisfaction. LS means were calculated using a MMRM with stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: Up to 52 weeks
Adult Low Blood Sugar Survey
The adult Low Blood Sugar Survey (LBSS) is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 4 = always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range of 0 to 132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using an analysis of covariance model (ANCOVA) with baseline LBSS score, stratification factors (country, HbA1c, and SU/meglitinide use), and treatment as fixed effects.
Time frame: Up to 52 weeks
Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)
LS means were calculated using a MMRM with baseline lipid measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: Baseline, 52 weeks
Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin
Time frame: Up to 52 weeks
Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)
The percentage of participants with a TEAR is summarized. TEAR is defined as a change in the anti-LY2605541 antibody level from undetectable at baseline to detectable at baseline, or, for those participants with detectable antibodies at baseline, change to a value with at least a 130% relative increase from baseline. Overall TEAR is defined as one or more TEAR during the specified period.
Time frame: Baseline to 78 weeks
Intra-participant Variability of the Fasting Blood Glucose (FBG)
Intra-participant variability of FBG, which was measured by SMBG, was assessed by the standard deviation of the FBG measurement at the Week 52 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
Time frame: 52 weeks
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
A hypoglycemic event is defined by a blood glucose value ≤70 mg/dL (3.9mmol/L). Total hypoglycemic events include documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemic events refer to any total hypoglycemic event that occurs between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic or nocturnal hypoglycemic events by the total number of participants analyzed, multiplied by 100.
Time frame: Baseline to 52 weeks
Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia
The percentage of participants with HbA1C ≤ 6.5% or \< 7.0% without nocturnal hypoglycemia is presented. Percentage was calculated by dividing the number of participants with the indicated HbA1c values over the total number of participants and multiplying by 100.
Time frame: Up to 52 weeks
Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
The percentage of participants was calculated by dividing the number of participants equal or above 2- or 3-fold ULN for ALT/SGPT or AST/SGOT by the total number of participants analyzed, multiplied by 100.
Time frame: Up to 52 weeks
| Milestone | LY2605541 | Glargine |
|---|---|---|
| Started | 1003 | 535 |
| Received at least 1 dose of study drug | 1003 | 535 |
| Completed | 832 | 455 |
| Not completed | 171 | 80 |
| Withdrew: Adverse event | 39 | 21 |
| Withdrew: Death | 7 | 2 |
| Withdrew: Lost to follow-up | 22 | 13 |
| Withdrew: Protocol violation | 16 | 13 |
| Withdrew: Withdrawal by subject | 66 | 24 |
| Withdrew: Physician decision | 20 | 7 |
| Withdrew: Sponsor decision | 1 | 0 |
HbA1C is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol \[LDL-C, \< 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL\] and sulfonylurea \[SU\]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects.
| percentage of HbA1c | LY2605541 | Glargine |
|---|---|---|
| Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c) | -1.55 ± 0.03 | -1.25 ± 0.04 |
Hypoglycemia is a condition that occurs when a person's blood glucose level is lower than the normal range (less than or equal to 70 milligrams per deciliter \[mg/dL\] or less than 3.9 millimoles per liter \[mmol/L\]). Total hypoglycemia refers to an event that meets the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemia refers to any total hypoglycemic event that occurs between bedtime and waking. Group mean (listed as LS means below) rates of total and nocturnal hypoglycemia were calculated using a negative binomial regression model (number of episodes = treatment + SU/meglitinide use + baseline hypoglycemia event rate, with log \[exposure per 30 days\] as the offset variable in the model).
| episodes/participant/30 days | LY2605541 | Glargine |
|---|---|---|
| Rate of total hypoglycemia events | 1.16 ± 0.06 | 1.21 ± 0.07 |
| Rate of nocturnal hypoglycemia events | 0.30 ± 0.02 | 0.40 ± 0.03 |
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 | Glargine |
|---|---|---|
| HbA1c ≤ 6.5% | 36.1 | 23.9 |
| HbA1c < 7.0% | 57.6 | 42.8 |
LS means were calculated using a MMRM with baseline fasting serum glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| mg/dL | LY2605541 | Glargine |
|---|---|---|
| Fasting Serum Glucose (By Laboratory Measurement) | 114.93 ± 1.24 | 120.13 ± 1.70 |
LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| mg/dL | LY2605541 | Glargine |
|---|---|---|
| Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings) | 112.57 ± 0.82 | 112.00 ± 1.12 |
Six-point SMBG profiles were obtained at pre-morning meal (fasting), pre-midday meal (lunch), pre-evening meal (dinner), bedtime, approximately 0300 hours, and pre-morning meal (fasting) the next day. Six-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to the next office visit. LS means were calculated using a MMRM with baseline blood glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| mg/dL | LY2605541 | Glargine |
|---|---|---|
| Pre-morning meal | 112.81 ± 0.96 | 112.26 ± 1.31 |
| Pre-midday meal | 127.65 ± 1.36 | 134.52 ± 1.86 |
| Pre-evening meal | 133.94 ± 1.40 | 142.58 ± 1.91 |
| Bedtime | 151.37 ± 1.54 | 155.19 ± 2.10 |
| 0300 hours | 120.35 ± 1.21 | 118.37 ± 1.67 |
| Pre-morning meal (next day) | 111.11 ± 0.89 | 109.19 ± 1.23 |
LS means were calculated using a MMRM with baseline body weight measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| kilograms (kg) | LY2605541 | Glargine |
|---|---|---|
| Change From Baseline to 52 Weeks in Body Weight | 2.06 ± 0.15 | 2.57 ± 0.21 |
HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| percentage of HbA1c | LY2605541 | Glargine |
|---|---|---|
| Hemoglobin A1c | 6.91 ± 0.03 | 7.21 ± 0.04 |
LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| units of insulin/kg body weight | LY2605541 | Glargine |
|---|---|---|
| Insulin Dose Per Body Weight | 0.45 ± 0.01 | 0.42 ± 0.01 |
Insulin doses were adjusted according to an algorithm (adapted from Riddle et al. 2003) during the first 26 weeks of the study and thereafter according to investigator judgment. Steady-state was defined as the first local maximum dose (maximum of moving 4-week interval) of LY2605541 or glargine within the window of +/- 2 weeks. The number of dose adjustments to steady-state was the total number of dose changes until steady-state was reached. LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| number of insulin dose adjustments | LY2605541 | Glargine |
|---|---|---|
| Number of Insulin Dose Adjustments to Steady-State | 5.83 ± 0.12 | 5.25 ± 0.16 |
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 to 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 a MMRM with baseline stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| units on a scale | LY2605541 | Glargine |
|---|---|---|
| European Quality of Life-5 Dimension (EQ-5D) | 0.88 ± 0.00 | 0.88 ± 0.01 |
The Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes who are receiving 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 total score on a scale of 0 to 100, where higher scores indicate better treatment satisfaction. LS means were calculated using a MMRM with stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| units on a scale | LY2605541 | Glargine |
|---|---|---|
| Insulin Treatment Satisfaction Questionnaire | 84.73 ± 0.44 | 85.04 ± 0.60 |
The adult Low Blood Sugar Survey (LBSS) is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 4 = always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range of 0 to 132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using an analysis of covariance model (ANCOVA) with baseline LBSS score, stratification factors (country, HbA1c, and SU/meglitinide use), and treatment as fixed effects.
| units on a scale | LY2605541 | Glargine |
|---|---|---|
| Adult Low Blood Sugar Survey | 15.09 ± 0.49 | 14.59 ± 0.67 |
LS means were calculated using a MMRM with baseline lipid measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| milligrams per deciliter (mg/dL) | LY2605541 | Glargine |
|---|---|---|
| Triglycerides | 10.60 ± 2.46 | -7.33 ± 3.38 |
| LDL-C | 1.44 ± 0.83 | 1.76 ± 1.14 |
| HDL-C | -1.91 ± 0.21 | -1.82 ± 0.29 |
| percentage of participants | LY2605541 | Glargine |
|---|---|---|
| ≥2-fold ULN | 0.2 | 0.0 |
| ≥3-fold ULN | 0.1 | 0.0 |
The percentage of participants with a TEAR is summarized. TEAR is defined as a change in the anti-LY2605541 antibody level from undetectable at baseline to detectable at baseline, or, for those participants with detectable antibodies at baseline, change to a value with at least a 130% relative increase from baseline. Overall TEAR is defined as one or more TEAR during the specified period.
| percentage of participants | LY2605541 | Glargine |
|---|---|---|
| Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR) | 43.0 | 37.8 |
Intra-participant variability of FBG, which was measured by SMBG, was assessed by the standard deviation of the FBG measurement at the Week 52 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
| mg/dL | LY2605541 | Glargine |
|---|---|---|
| Intra-participant Variability of the Fasting Blood Glucose (FBG) | 15.56 ± 0.38 | 17.08 ± 0.52 |
A hypoglycemic event is defined by a blood glucose value ≤70 mg/dL (3.9mmol/L). Total hypoglycemic events include documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemic events refer to any total hypoglycemic event that occurs between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic or nocturnal hypoglycemic events by the total number of participants analyzed, multiplied by 100.
| percentage of participants | LY2605541 | Glargine |
|---|---|---|
| Total hypoglycemic events | 77.0 | 79.8 |
| Nocturnal hypoglycemic events | 48.9 | 59.8 |
The percentage of participants with HbA1C ≤ 6.5% or \< 7.0% without nocturnal hypoglycemia is presented. Percentage was calculated by dividing the number of participants with the indicated HbA1c values over the total number of participants and multiplying by 100.
| percentage of participants | LY2605541 | Glargine |
|---|---|---|
| HbA1c ≤ 6.5% | 17.5 | 8.6 |
| HbA1c < 7.0% | 26.2 | 15.3 |
The percentage of participants was calculated by dividing the number of participants equal or above 2- or 3-fold ULN for ALT/SGPT or AST/SGOT by the total number of participants analyzed, multiplied by 100.
| percentage of participants | LY2605541 | Glargine |
|---|---|---|
| ≥2-fold ULN for ALT | 6.5 | 4.0 |
| ≥3-fold ULN for ALT | 1.9 | 0.6 |
| ≥2-fold ULN for AST | 3.6 | 1.5 |
| ≥3-fold ULN for AST | 1.0 | 0.4 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LY2605541 | — | 105/1,003 (10.5%) | 733/1,003 (73.1%) |
| Glargine | — | 73/535 (13.6%) | 390/535 (72.9%) |
| Event | LY2605541 | Glargine |
|---|---|---|
| Coronary artery diseaseCardiac disorders | 3/1003 | 5/535 |
| PneumoniaInfections and infestations | 3/1003 | 4/535 |
| HypoglycaemiaMetabolism and nutrition disorders | 7/1003 | 4/535 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/550 | 2/308 |
| Angina unstableCardiac disorders | 1/1003 | 3/535 |
| Myocardial infarctionCardiac disorders | 5/1003 | 3/535 |
| Transient ischaemic attackNervous system disorders | 2/1003 | 3/535 |
| Atrial fibrillationCardiac disorders | 5/1003 | 0/535 |
| Chest painGeneral disorders | 5/1003 | 0/535 |
| CellulitisInfections and infestations | 5/1003 | 0/535 |
| Event | LY2605541 | Glargine |
|---|---|---|
| NasopharyngitisInfections and infestations | 141/1003 | 82/535 |
| HeadacheNervous system disorders | 85/1003 | 37/535 |
| Upper respiratory tract infectionInfections and infestations | 83/1003 | 33/535 |
| DiarrhoeaGastrointestinal disorders | 57/1003 | 38/535 |
| Back painMusculoskeletal and connective tissue disorders | 70/1003 | 36/535 |
| InfluenzaInfections and infestations | 59/1003 | 28/535 |
| BronchitisInfections and infestations | 52/1003 | 24/535 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 52/1003 | 20/535 |
| Urinary tract infectionInfections and infestations | 47/1003 | 22/535 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 42/1003 | 25/535 |
All randomized participants.
| Age, Continuous(years) | LY2605541 | Glargine | Total |
|---|---|---|---|
| Mean | 58.80 ± 9.85 | 59.35 ± 9.80 | 58.99 ± 9.84 |
| Sex: Female, Male(Participants) | LY2605541 | Glargine | Total |
|---|---|---|---|
| Female | 453 | 227 | 680 |
| Male | 550 | 308 | 858 |
| Ethnicity (NIH/OMB)(Participants) | LY2605541 | Glargine | Total |
|---|---|---|---|
| Hispanic or Latino | 201 | 96 | 297 |
| Not Hispanic or Latino | 648 | 355 | 1003 |
| Unknown or Not Reported | 154 | 84 | 238 |
| Race (NIH/OMB)(Participants) | LY2605541 | Glargine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 24 | 15 | 39 |
| Asian | 25 | 12 | 37 |
| Native Hawaiian or Other Pacific Islander | 3 | 2 | 5 |
| Black or African American | 68 | 34 | 102 |
| White | 875 | 469 | 1344 |
| More than one race | 8 | 3 | 11 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | LY2605541 | Glargine | Total |
|---|---|---|---|
| United States | 371 | 188 | 559 |
| Slovakia | 12 | 10 | 22 |
| Greece | 18 | 12 | 30 |
| Finland | 6 | 7 | 13 |
| Spain | 35 | 18 | 53 |
| Turkey | 7 | 4 | 11 |
| Lithuania | 8 | 4 | 12 |
| Israel | 16 | 8 | 24 |
| Russia | 32 | 18 | 50 |
| Italy | 24 | 13 | 37 |
| United Kingdom | 12 | 5 | 17 |
| Hungary | 69 | 33 | 102 |
| Mexico | 24 | 16 | 40 |
| Puerto Rico | 39 | 19 | 58 |
| Canada | 16 | 11 | 27 |
| Argentina | 67 | 34 | 101 |
| Brazil | 20 | 10 | 30 |
| Poland | 67 | 32 | 99 |
| Romania | 40 | 22 | 62 |
| Australia | 27 | 18 | 45 |
| South Africa | 11 | 4 | 15 |
| Germany | 63 | 36 | 99 |
| New Zealand | 10 | 9 | 19 |
| Czechia | 9 | 4 | 13 |
Showing the first 100 of 167 sites across 23 countries.
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