Trial Outcomes & Findings for A Study in Patients With Type 2 Diabetes Mellitus (NCT NCT01435616)
NCT ID: NCT01435616
Last Updated: 2018-04-13
Results Overview
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.
COMPLETED
PHASE3
1538 participants
Baseline, 52 weeks
2018-04-13
Participant Flow
Participant milestones
| Measure |
LY2605541
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
|
Glargine
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
|
|---|---|---|
|
Overall Study
STARTED
|
1003
|
535
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
1003
|
535
|
|
Overall Study
COMPLETED
|
832
|
455
|
|
Overall Study
NOT COMPLETED
|
171
|
80
|
Reasons for withdrawal
| Measure |
LY2605541
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
|
Glargine
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
39
|
21
|
|
Overall Study
Death
|
7
|
2
|
|
Overall Study
Lost to Follow-up
|
22
|
13
|
|
Overall Study
Protocol Violation
|
16
|
13
|
|
Overall Study
Withdrawal by Subject
|
66
|
24
|
|
Overall Study
Physician Decision
|
20
|
7
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
Baseline Characteristics
A Study in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
LY2605541
n=1003 Participants
LY2605541 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
|
Glargine
n=535 Participants
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
|
Total
n=1538 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.80 years
STANDARD_DEVIATION 9.85 • n=5 Participants
|
59.35 years
STANDARD_DEVIATION 9.80 • n=7 Participants
|
58.99 years
STANDARD_DEVIATION 9.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
453 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
680 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
550 Participants
n=5 Participants
|
308 Participants
n=7 Participants
|
858 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
201 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
648 Participants
n=5 Participants
|
355 Participants
n=7 Participants
|
1003 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
154 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
24 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
68 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
875 Participants
n=5 Participants
|
469 Participants
n=7 Participants
|
1344 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
371 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
559 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
35 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
32 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
69 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
39 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
67 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
67 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
40 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
63 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 52 weeksPopulation: All participants who were randomized, had at least 1 dose of study medication, and at least 1 post-baseline HbA1c measurement.
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.
Outcome measures
| Measure |
LY2605541
n=989 Participants
LY2605541 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 weeks
|
Glargine
n=523 Participants
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 weeks
|
|---|---|---|
|
Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)
|
-1.55 percentage of HbA1c
Standard Error 0.03
|
-1.25 percentage of HbA1c
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: All participants who were randomized, who received at least 1 dose of study drug, and had evaluable total and/or nocturnal event data.
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).
Outcome measures
| Measure |
LY2605541
n=1001 Participants
LY2605541 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 weeks
|
Glargine
n=535 Participants
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 weeks
|
|---|---|---|
|
Rate of Total and Nocturnal Hypoglycemia Events
Rate of total hypoglycemia events
|
1.16 episodes/participant/30 days
Standard Error 0.06
|
1.21 episodes/participant/30 days
Standard Error 0.07
|
|
Rate of Total and Nocturnal Hypoglycemia Events
Rate of nocturnal hypoglycemia events
|
0.30 episodes/participant/30 days
Standard Error 0.02
|
0.40 episodes/participant/30 days
Standard Error 0.03
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement.
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.
Outcome measures
| Measure |
LY2605541
n=989 Participants
LY2605541 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 weeks
|
Glargine
n=523 Participants
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 weeks
|
|---|---|---|
|
Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %
HbA1c ≤ 6.5%
|
36.1 percentage of participants
|
23.9 percentage of participants
|
|
Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %
HbA1c < 7.0%
|
57.6 percentage of participants
|
42.8 percentage of participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting serum glucose data.
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.
Outcome measures
| Measure |
LY2605541
n=986 Participants
LY2605541 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 weeks
|
Glargine
n=521 Participants
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 weeks
|
|---|---|---|
|
Fasting Serum Glucose (By Laboratory Measurement)
|
114.93 mg/dL
Standard Error 1.24
|
120.13 mg/dL
Standard Error 1.70
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting blood glucose data.
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.
Outcome measures
| Measure |
LY2605541
n=994 Participants
LY2605541 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 weeks
|
Glargine
n=528 Participants
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 weeks
|
|---|---|---|
|
Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)
|
112.57 mg/dL
Standard Error 0.82
|
112.00 mg/dL
Standard Error 1.12
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable SMBG data.
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.
Outcome measures
| Measure |
LY2605541
n=943 Participants
LY2605541 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 weeks
|
Glargine
n=499 Participants
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 weeks
|
|---|---|---|
|
6 Point Self-monitored Blood Glucose (SMBG)
Pre-morning meal
|
112.81 mg/dL
Standard Error 0.96
|
112.26 mg/dL
Standard Error 1.31
|
|
6 Point Self-monitored Blood Glucose (SMBG)
Pre-midday meal
|
127.65 mg/dL
Standard Error 1.36
|
134.52 mg/dL
Standard Error 1.86
|
|
6 Point Self-monitored Blood Glucose (SMBG)
Pre-evening meal
|
133.94 mg/dL
Standard Error 1.40
|
142.58 mg/dL
Standard Error 1.91
|
|
6 Point Self-monitored Blood Glucose (SMBG)
Bedtime
|
151.37 mg/dL
Standard Error 1.54
|
155.19 mg/dL
Standard Error 2.10
|
|
6 Point Self-monitored Blood Glucose (SMBG)
0300 hours
|
120.35 mg/dL
Standard Error 1.21
|
118.37 mg/dL
Standard Error 1.67
|
|
6 Point Self-monitored Blood Glucose (SMBG)
Pre-morning meal (next day)
|
111.11 mg/dL
Standard Error 0.89
|
109.19 mg/dL
Standard Error 1.23
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All participants who were randomized, who received at least 1 dose of study drug, and had evaluable body weight data.
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.
Outcome measures
| Measure |
LY2605541
n=985 Participants
LY2605541 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 weeks
|
Glargine
n=522 Participants
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 weeks
|
|---|---|---|
|
Change From Baseline to 52 Weeks in Body Weight
|
2.06 kilograms (kg)
Standard Error 0.15
|
2.57 kilograms (kg)
Standard Error 0.21
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement.
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.
Outcome measures
| Measure |
LY2605541
n=989 Participants
LY2605541 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 weeks
|
Glargine
n=523 Participants
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 weeks
|
|---|---|---|
|
Hemoglobin A1c
|
6.91 percentage of HbA1c
Standard Error 0.03
|
7.21 percentage of HbA1c
Standard Error 0.04
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable insulin dose data.
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.
Outcome measures
| Measure |
LY2605541
n=1001 Participants
LY2605541 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 weeks
|
Glargine
n=532 Participants
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 weeks
|
|---|---|---|
|
Insulin Dose Per Body Weight
|
0.45 units of insulin/kg body weight
Standard Error 0.01
|
0.42 units of insulin/kg body weight
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline insulin data.
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.
Outcome measures
| Measure |
LY2605541
n=1002 Participants
LY2605541 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 weeks
|
Glargine
n=532 Participants
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 weeks
|
|---|---|---|
|
Number of Insulin Dose Adjustments to Steady-State
|
5.83 number of insulin dose adjustments
Standard Error 0.12
|
5.25 number of insulin dose adjustments
Standard Error 0.16
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable EQ-5D data.
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.
Outcome measures
| Measure |
LY2605541
n=892 Participants
LY2605541 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 weeks
|
Glargine
n=474 Participants
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 weeks
|
|---|---|---|
|
European Quality of Life-5 Dimension (EQ-5D)
|
0.88 units on a scale
Standard Error 0.00
|
0.88 units on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable ITSQ data.
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.
Outcome measures
| Measure |
LY2605541
n=966 Participants
LY2605541 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 weeks
|
Glargine
n=515 Participants
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 weeks
|
|---|---|---|
|
Insulin Treatment Satisfaction Questionnaire
|
84.73 units on a scale
Standard Error 0.44
|
85.04 units on a scale
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable LBSS data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.
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.
Outcome measures
| Measure |
LY2605541
n=899 Participants
LY2605541 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 weeks
|
Glargine
n=478 Participants
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 weeks
|
|---|---|---|
|
Adult Low Blood Sugar Survey
|
15.09 units on a scale
Standard Error 0.49
|
14.59 units on a scale
Standard Error 0.67
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline lipid measurement.
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.
Outcome measures
| Measure |
LY2605541
n=992 Participants
LY2605541 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 weeks
|
Glargine
n=528 Participants
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 weeks
|
|---|---|---|
|
Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)
Triglycerides
|
10.60 milligrams per deciliter (mg/dL)
Standard Error 2.46
|
-7.33 milligrams per deciliter (mg/dL)
Standard Error 3.38
|
|
Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)
LDL-C
|
1.44 milligrams per deciliter (mg/dL)
Standard Error 0.83
|
1.76 milligrams per deciliter (mg/dL)
Standard Error 1.14
|
|
Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)
HDL-C
|
-1.91 milligrams per deciliter (mg/dL)
Standard Error 0.21
|
-1.82 milligrams per deciliter (mg/dL)
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: All participants who were randomized, had at least 1 dose of study drug, and had at least 1 post-baseline total bilirubin measurement.
Outcome measures
| Measure |
LY2605541
n=994 Participants
LY2605541 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 weeks
|
Glargine
n=529 Participants
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 weeks
|
|---|---|---|
|
Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin
≥2-fold ULN
|
0.2 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin
≥3-fold ULN
|
0.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to 78 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable TEAR data.
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.
Outcome measures
| Measure |
LY2605541
n=988 Participants
LY2605541 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 weeks
|
Glargine
n=521 Participants
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 weeks
|
|---|---|---|
|
Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)
|
43.0 percentage of participants
|
37.8 percentage of participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline FBG data.
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.
Outcome measures
| Measure |
LY2605541
n=991 Participants
LY2605541 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 weeks
|
Glargine
n=522 Participants
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 weeks
|
|---|---|---|
|
Intra-participant Variability of the Fasting Blood Glucose (FBG)
|
15.56 mg/dL
Standard Error 0.38
|
17.08 mg/dL
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable hypoglycemia event data.
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.
Outcome measures
| Measure |
LY2605541
n=1001 Participants
LY2605541 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 weeks
|
Glargine
n=535 Participants
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 weeks
|
|---|---|---|
|
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
Total hypoglycemic events
|
77.0 percentage of participants
|
79.8 percentage of participants
|
|
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
Nocturnal hypoglycemic events
|
48.9 percentage of participants
|
59.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement. Missing endpoints were imputed with the LOCF method, using only post-baseline data.
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.
Outcome measures
| Measure |
LY2605541
n=989 Participants
LY2605541 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 weeks
|
Glargine
n=523 Participants
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 weeks
|
|---|---|---|
|
Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia
HbA1c ≤ 6.5%
|
17.5 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia
HbA1c < 7.0%
|
26.2 percentage of participants
|
15.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline liver enzyme data.
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.
Outcome measures
| Measure |
LY2605541
n=990 Participants
LY2605541 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 weeks
|
Glargine
n=524 Participants
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 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)
≥2-fold ULN for ALT
|
6.5 percentage of participants
|
4.0 percentage of participants
|
|
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)
≥3-fold ULN for ALT
|
1.9 percentage of participants
|
0.6 percentage of participants
|
|
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)
≥2-fold ULN for AST
|
3.6 percentage of participants
|
1.5 percentage of participants
|
|
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)
≥3-fold ULN for AST
|
1.0 percentage of participants
|
0.4 percentage of participants
|
Adverse Events
LY2605541
Glargine
Serious adverse events
| Measure |
LY2605541
n=1003 participants at risk
LY2605541 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 weeks
|
Glargine
n=535 participants at risk
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 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
2/1003 • Number of events 4
|
0.19%
1/535 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
1/1003 • Number of events 3
|
0.00%
0/535
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
1/1003 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal cyst
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1003
|
0.37%
2/535 • Number of events 2
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
2/1003 • Number of events 2
|
0.37%
2/535 • Number of events 2
|
|
Cardiac disorders
Angina pectoris
|
0.30%
3/1003 • Number of events 3
|
0.00%
0/535
|
|
Cardiac disorders
Angina unstable
|
0.10%
1/1003 • Number of events 1
|
0.56%
3/535 • Number of events 3
|
|
Cardiac disorders
Aortic valve stenosis
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.10%
1/1003 • Number of events 2
|
0.19%
1/535 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
5/1003 • Number of events 5
|
0.00%
0/535
|
|
Cardiac disorders
Atrial flutter
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Cardiac disorders
Atrioventricular block
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Cardiac disorders
Atrioventricular block complete
|
0.10%
1/1003 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Cardiac disorders
Cardiac arrest
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Cardiac disorders
Cardiac failure
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
2/1003 • Number of events 3
|
0.19%
1/535 • Number of events 2
|
|
Cardiac disorders
Cardiac tamponade
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Cardiac disorders
Cardiomyopathy
|
0.10%
1/1003 • Number of events 2
|
0.00%
0/535
|
|
Cardiac disorders
Coronary artery disease
|
0.30%
3/1003 • Number of events 6
|
0.93%
5/535 • Number of events 8
|
|
Cardiac disorders
Hypertensive heart disease
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Cardiac disorders
Myocardial infarction
|
0.50%
5/1003 • Number of events 5
|
0.56%
3/535 • Number of events 3
|
|
Cardiac disorders
Myocardial ischaemia
|
0.10%
1/1003 • Number of events 1
|
0.19%
1/535 • Number of events 3
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Ear and labyrinth disorders
Tinnitus
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Ear and labyrinth disorders
Vertigo
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Ear and labyrinth disorders
Vestibular ataxia
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Eye disorders
Cataract
|
0.10%
1/1003 • Number of events 2
|
0.00%
0/535
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.10%
1/1003 • Number of events 3
|
0.00%
0/535
|
|
Eye disorders
Vitreous haemorrhage
|
0.10%
1/1003 • Number of events 3
|
0.00%
0/535
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Ascites
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Gastric fistula
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Gastrointestinal disorders
Gastroenteritis eosinophilic
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Oesophagitis
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
1/1003 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
General disorders
Chest pain
|
0.50%
5/1003 • Number of events 5
|
0.00%
0/535
|
|
General disorders
Death
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
General disorders
Device occlusion
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
General disorders
Non-cardiac chest pain
|
0.30%
3/1003 • Number of events 3
|
0.19%
1/535 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.10%
1/1003 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.40%
4/1003 • Number of events 5
|
0.00%
0/535
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Immune system disorders
Sarcoidosis
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Infections and infestations
Abdominal abscess
|
0.10%
1/1003 • Number of events 3
|
0.00%
0/535
|
|
Infections and infestations
Bronchitis
|
0.10%
1/1003 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.50%
5/1003 • Number of events 7
|
0.00%
0/535
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Infections and infestations
Escherichia bacteraemia
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Infections and infestations
Gallbladder empyema
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Infections and infestations
Gastroenteritis
|
0.10%
1/1003 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Infections and infestations
Liver abscess
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Infections and infestations
Necrotising fasciitis
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Infections and infestations
Osteomyelitis
|
0.10%
1/1003 • Number of events 1
|
0.37%
2/535 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
0.30%
3/1003 • Number of events 3
|
0.75%
4/535 • Number of events 5
|
|
Infections and infestations
Sepsis
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Infections and infestations
Staphylococcal infection
|
0.20%
2/1003 • Number of events 2
|
0.00%
0/535
|
|
Infections and infestations
Urinary tract infection
|
0.20%
2/1003 • Number of events 4
|
0.00%
0/535
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 2
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
2/1003 • Number of events 2
|
0.19%
1/535 • Number of events 1
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.10%
1/1003 • Number of events 4
|
0.19%
1/535 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Investigations
Weight increased
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.70%
7/1003 • Number of events 7
|
0.75%
4/535 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.10%
1/1003 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.10%
1/1003 • Number of events 2
|
0.00%
0/535
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.30%
3/1003 • Number of events 7
|
0.00%
0/535
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.20%
2/1003 • Number of events 2
|
0.00%
0/535
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.10%
1/1003 • Number of events 2
|
0.00%
0/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastric neoplasm
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.22%
1/453 • Number of events 1
|
0.00%
0/227
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.20%
2/1003 • Number of events 2
|
0.00%
0/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to salivary gland
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.36%
2/550 • Number of events 2
|
0.65%
2/308 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/550
|
0.32%
1/308 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage iii
|
0.00%
0/550
|
0.32%
1/308 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.10%
1/1003 • Number of events 2
|
0.00%
0/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.10%
1/1003 • Number of events 2
|
0.00%
0/535
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.10%
1/1003 • Number of events 2
|
0.19%
1/535 • Number of events 1
|
|
Nervous system disorders
Autonomic neuropathy
|
0.10%
1/1003 • Number of events 2
|
0.00%
0/535
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
3/1003 • Number of events 4
|
0.00%
0/535
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Nervous system disorders
Diabetic neuropathy
|
0.10%
1/1003 • Number of events 2
|
0.19%
1/535 • Number of events 1
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Nervous system disorders
Ischaemic stroke
|
0.20%
2/1003 • Number of events 2
|
0.19%
1/535 • Number of events 1
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.20%
2/1003 • Number of events 2
|
0.56%
3/535 • Number of events 4
|
|
Renal and urinary disorders
Renal failure acute
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.22%
1/453 • Number of events 1
|
0.00%
0/227
|
|
Reproductive system and breast disorders
Pelvic floor muscle weakness
|
0.22%
1/453 • Number of events 1
|
0.00%
0/227
|
|
Skin and subcutaneous tissue disorders
Vasculitic rash
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.10%
1/1003 • Number of events 1
|
0.19%
1/535 • Number of events 1
|
|
Surgical and medical procedures
Glossectomy
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/550
|
0.32%
1/308 • Number of events 1
|
|
Surgical and medical procedures
Radical neck dissection
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
0.10%
1/1003 • Number of events 3
|
0.00%
0/535
|
|
Vascular disorders
Arteriosclerosis
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
2/1003 • Number of events 2
|
0.00%
0/535
|
|
Vascular disorders
Hypertension
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Vascular disorders
Hypoperfusion
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Vascular disorders
Hypotension
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Vascular disorders
Iliac artery occlusion
|
0.10%
1/1003 • Number of events 2
|
0.00%
0/535
|
|
Vascular disorders
Malignant hypertension
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.10%
1/1003 • Number of events 1
|
0.00%
0/535
|
|
Vascular disorders
Shock
|
0.00%
0/1003
|
0.19%
1/535 • Number of events 1
|
Other adverse events
| Measure |
LY2605541
n=1003 participants at risk
LY2605541 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 weeks
|
Glargine
n=535 participants at risk
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 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
57/1003 • Number of events 81
|
7.1%
38/535 • Number of events 52
|
|
Gastrointestinal disorders
Nausea
|
3.7%
37/1003 • Number of events 51
|
3.4%
18/535 • Number of events 30
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
35/1003 • Number of events 49
|
3.0%
16/535 • Number of events 21
|
|
General disorders
Fatigue
|
3.5%
35/1003 • Number of events 38
|
2.6%
14/535 • Number of events 15
|
|
Infections and infestations
Bronchitis
|
5.2%
52/1003 • Number of events 60
|
4.5%
24/535 • Number of events 26
|
|
Infections and infestations
Influenza
|
5.9%
59/1003 • Number of events 68
|
5.2%
28/535 • Number of events 35
|
|
Infections and infestations
Nasopharyngitis
|
14.1%
141/1003 • Number of events 196
|
15.3%
82/535 • Number of events 122
|
|
Infections and infestations
Sinusitis
|
3.8%
38/1003 • Number of events 51
|
3.0%
16/535 • Number of events 17
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
83/1003 • Number of events 119
|
6.2%
33/535 • Number of events 48
|
|
Infections and infestations
Urinary tract infection
|
4.7%
47/1003 • Number of events 57
|
4.1%
22/535 • Number of events 28
|
|
Investigations
Weight increased
|
2.6%
26/1003 • Number of events 28
|
3.4%
18/535 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
52/1003 • Number of events 68
|
3.7%
20/535 • Number of events 47
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
70/1003 • Number of events 89
|
6.7%
36/535 • Number of events 47
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
42/1003 • Number of events 50
|
4.7%
25/535 • Number of events 36
|
|
Nervous system disorders
Dizziness
|
3.2%
32/1003 • Number of events 36
|
3.2%
17/535 • Number of events 29
|
|
Nervous system disorders
Headache
|
8.5%
85/1003 • Number of events 134
|
6.9%
37/535 • Number of events 72
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
44/1003 • Number of events 52
|
3.4%
18/535 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
34/1003 • Number of events 40
|
3.6%
19/535 • Number of events 21
|
|
Vascular disorders
Hypertension
|
4.1%
41/1003 • Number of events 43
|
2.2%
12/535 • Number of events 12
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60