Trial Outcomes & Findings for A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (NCT NCT03214380)
NCT ID: NCT03214380
Last Updated: 2020-03-27
Results Overview
Change from baseline in HbA1c was performed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
933 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2020-03-27
Participant Flow
The purpose of the Lead-in Period was to titrate basal insulin prior to randomization. Participants were then randomized to receive Insulin lispro (Humalog) or LY900014 in the Treatment Period (Period 2).
Participant milestones
| Measure |
Insulin Lispro (Humalog) Lead-In
100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog)
100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment
100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)
100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014 (MEE)
100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|---|---|---|---|
|
Lead-in
STARTED
|
750
|
0
|
0
|
183
|
0
|
0
|
|
Lead-in
Received at Least 1 Dose Lead-in Insulin
|
750
|
0
|
0
|
183
|
0
|
0
|
|
Lead-in
COMPLETED
|
673
|
0
|
0
|
164
|
0
|
0
|
|
Lead-in
NOT COMPLETED
|
77
|
0
|
0
|
19
|
0
|
0
|
|
Treatment Period
STARTED
|
0
|
337
|
336
|
0
|
82
|
82
|
|
Treatment Period
Received at Least 1 Dose of Study Drug
|
0
|
337
|
336
|
0
|
82
|
82
|
|
Treatment Period
COMPLETED
|
0
|
319
|
320
|
0
|
73
|
71
|
|
Treatment Period
NOT COMPLETED
|
0
|
18
|
16
|
0
|
9
|
11
|
Reasons for withdrawal
| Measure |
Insulin Lispro (Humalog) Lead-In
100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog)
100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment
100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)
100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014 (MEE)
100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|---|---|---|---|
|
Lead-in
Adverse Event
|
3
|
0
|
0
|
1
|
0
|
0
|
|
Lead-in
Lost to Follow-up
|
4
|
0
|
0
|
1
|
0
|
0
|
|
Lead-in
Eligibility Criteria
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in
Physician Decision
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in
Protocol Deviation
|
7
|
0
|
0
|
3
|
0
|
0
|
|
Lead-in
Withdrawal by Subject
|
41
|
0
|
0
|
14
|
0
|
0
|
|
Lead-in
Family Emergency
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in
Natural Disaster
|
9
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in
Non Compliance
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Lead-in
Participant Schedule
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Adverse Event
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Treatment Period
Non-Compliance with Study Drug
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period
Withdrawal by Subject
|
0
|
10
|
8
|
0
|
7
|
11
|
|
Treatment Period
Death
|
0
|
1
|
2
|
0
|
0
|
0
|
|
Treatment Period
Lost to Follow-up
|
0
|
6
|
3
|
0
|
0
|
0
|
|
Treatment Period
Participant schedule
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period
Treatment Interruption
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Insulin Lispro (Humalog)
n=337 Participants
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=336 Participants
LY900014 given subcutaneously (SC) with each meal with either 100 U/mL (U-100) basal insulin glargine given SC once or twice daily or U-100 or 200 U/mL (U-200) insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog) MEE
n=82 Participants
Insulin lispro given SC with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014 Maximum Extended Enrollment (MEE)
n=82 Participants
LY900014 given subcutaneously (SC) with each meal with either U-100 basal insulin glargine given SC once or twice daily or U-100 or U-200 insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Total
n=837 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
59.9 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
388 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
175 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
449 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
81 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
303 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
229 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
487 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
Argentina
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Region of Enrollment
Puerto Rico
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
95 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
187 Participants
n=21 Participants
|
|
Region of Enrollment
Czechia
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
93 Participants
n=21 Participants
|
|
Region of Enrollment
India
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Region of Enrollment
Russia
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Region of Enrollment
South Korea
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Region of Enrollment
Taiwan
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Region of Enrollment
Slovakia
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Hemoglobin A1c
|
7.31 percentage of HbA1c
STANDARD_DEVIATION 0.71 • n=5 Participants
|
7.27 percentage of HbA1c
STANDARD_DEVIATION 0.68 • n=7 Participants
|
7.53 percentage of HbA1c
STANDARD_DEVIATION 0.69 • n=5 Participants
|
7.67 percentage of HbA1c
STANDARD_DEVIATION 0.89 • n=4 Participants
|
7.35 percentage of HbA1c
STANDARD_DEVIATION 0.73 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants with baseline and at least 1 post-baseline HbA1c data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.
Change from baseline in HbA1c was performed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=335 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=334 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26
|
-0.43 percentage of HbA1c
Standard Error 0.042
|
-0.38 percentage of HbA1c
Standard Error 0.042
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants with baseline and at least one post-baseline 1-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
1-hour PPG excursion during MMTT uses the analysis of covariance (ANCOVA) model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=307 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=304 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand
|
74.9 milligrams per deciliter (mg/dL)
Standard Error 3.60
|
63.1 milligrams per deciliter (mg/dL)
Standard Error 3.60
|
SECONDARY outcome
Timeframe: Week 26Population: All randomized participants with baseline and at least one post-baseline 2-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=306 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=305 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
2-hour PPG Excursion During MMTT Efficacy Estimand
|
97.8 mg/dL
Standard Error 4.50
|
80.4 mg/dL
Standard Error 4.50
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group \*36525. Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience com with or without seizures, and may require parenteral therapy.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=337 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=336 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
Rate of Severe Hypoglycemia
|
4.19 Events per 100 participant years
|
2.44 Events per 100 participant years
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of \<54 mg/dL \[3.0 millimole per liter (mmol/L)\]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=337 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=336 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
Rate of Documented Symptomatic Hypoglycemia
|
1.34 Events per participant per 30 days/year
Standard Error 0.164
|
2.21 Events per participant per 30 days/year
Standard Error 0.318
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants with baseline and at least one post-baseline 1,5-AG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Change from baseline in 1,5-AG was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=334 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=331 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26
|
2.15 milligram per liter (mg/L)
Standard Error 0.234
|
1.99 milligram per liter (mg/L)
Standard Error 0.235
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants with baseline and at least one post-baseline SMBG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Change from baseline in 10-point SMBG values was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=276 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=270 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Midday 1-hour Postmeal
|
3.0 mg/dL
Standard Error 3.48
|
-2.0 mg/dL
Standard Error 3.47
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Midday 2-hour Postmeal
|
-2.2 mg/dL
Standard Error 3.28
|
-6.5 mg/dL
Standard Error 3.27
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Evening Premeal
|
7.0 mg/dL
Standard Error 3.38
|
10.1 mg/dL
Standard Error 3.38
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Evening 1-hour Postmeal
|
-2.1 mg/dL
Standard Error 3.24
|
-3.0 mg/dL
Standard Error 3.27
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Evening 2-hour Postmeal
|
0.2 mg/dL
Standard Error 3.68
|
-2.1 mg/dL
Standard Error 3.73
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Bedtime
|
-3.4 mg/dL
Standard Error 4.00
|
-2.2 mg/dL
Standard Error 4.02
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Morning Premeal
|
-0.8 mg/dL
Standard Error 2.72
|
1.5 mg/dL
Standard Error 2.74
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Morning 1-hour Postmeal
|
-2.0 mg/dL
Standard Error 3.44
|
-14.1 mg/dL
Standard Error 3.44
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Morning 2-hour Postmeal
|
0.6 mg/dL
Standard Error 3.38
|
-14.9 mg/dL
Standard Error 3.38
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26
Midday Premeal
|
2.4 mg/dL
Standard Error 2.83
|
4.1 mg/dL
Standard Error 2.84
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants with baseline and at least one post-baseline basal insulin dose data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Change from baseline in insulin dose was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=330 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=330 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
Change From Baseline in Insulin Dose at Week 26
Basal Insulin Dose
|
4.2 Units (U)
Standard Error 0.82
|
4.6 Units (U)
Standard Error 0.81
|
|
Change From Baseline in Insulin Dose at Week 26
Prandial Insulin Dose
|
8.3 Units (U)
Standard Error 1.41
|
12.0 Units (U)
Standard Error 1.41
|
|
Change From Baseline in Insulin Dose at Week 26
Total Daily Insulin Dose
|
12.1 Units (U)
Standard Error 1.93
|
17.3 Units (U)
Standard Error 1.92
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants with baseline and post-baseline data. Missing endpoints were imputed by applying the Last Observation Carried Forward (LOCF) method to post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. Change from baseline in ITSQ regimen inconvenience domain score was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=319 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=319 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26
|
-0.9 units on a scale
Standard Error 1.36
|
-2.4 units on a scale
Standard Error 1.37
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All randomized participants with baseline and post-baseline data. Missing endpoints were imputed by applying the LOCF method to the post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. Change from baseline in ITSQ lifestyle flexibility domain score was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=319 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=319 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26
|
1.4 units on a scale
Standard Error 1.60
|
0.2 units on a scale
Standard Error 1.60
|
SECONDARY outcome
Timeframe: Week 26Population: All participants with baseline and one post-baseline observation while on study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Number of participants with HbA1c \<7% at Week 26.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=320 Participants
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=316 Participants
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|
|
Number of Participants With HbA1c <7%
|
168 Participants
|
184 Participants
|
Adverse Events
Insulin Lispro (Humalog) Lead-In
Serious events: 13 serious events
Other events: 44 other events
Deaths: 0 deaths
Insulin Lispro (Humalog)
Serious events: 26 serious events
Other events: 60 other events
Deaths: 1 deaths
LY900014
Serious events: 26 serious events
Other events: 79 other events
Deaths: 2 deaths
Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
LY900014 (MEE)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro (Humalog) Lead-In
n=750 participants at risk
100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog)
n=337 participants at risk
100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=336 participants at risk
100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment
n=183 participants at risk
100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)
n=82 participants at risk
100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014 (MEE)
n=82 participants at risk
100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
1.2%
1/82 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.59%
2/337 • Number of events 2 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Eye disorders
Cataract
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Eye disorders
Papilloedema
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.55%
1/183 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
General disorders
Sudden death
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Immune system disorders
Drug hypersensitivity
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Empyema
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.55%
1/183 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Eye infection viral
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Pneumonia
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
1.2%
4/336 • Number of events 4 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Septic shock
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
1.2%
1/82 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Injury, poisoning and procedural complications
Fall
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
1.2%
1/82 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.27%
2/750 • Number of events 2 • Baseline up to 30 Weeks
All randomized participants.
|
1.5%
5/337 • Number of events 6 • Baseline up to 30 Weeks
All randomized participants.
|
0.89%
3/336 • Number of events 4 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
1.2%
1/82 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
1.2%
1/82 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
1.2%
1/82 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
1.2%
1/82 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Renal and urinary disorders
Ureteric compression
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.60%
2/336 • Number of events 2 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.89%
3/336 • Number of events 3 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.60%
2/336 • Number of events 2 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal disorder
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.55%
1/183 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Vascular disorders
Intermittent claudication
|
0.13%
1/750 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/337 • Number of events 2 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/336 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/750 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/337 • Baseline up to 30 Weeks
All randomized participants.
|
0.30%
1/336 • Number of events 1 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/183 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
Other adverse events
| Measure |
Insulin Lispro (Humalog) Lead-In
n=750 participants at risk
100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog)
n=337 participants at risk
100 U/mL Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014
n=336 participants at risk
100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment
n=183 participants at risk
100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
Insulin Lispro (Humalog) Maximum Extended Enrollment (MEE)
n=82 participants at risk
100 U/mL Insulin lispro (Humalog) SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
LY900014 (MEE)
n=82 participants at risk
100 U/mL LY900014 SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Prandial insulin doses were individualized and titrated according to protocol-defined targets.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
11/750 • Number of events 11 • Baseline up to 30 Weeks
All randomized participants.
|
3.0%
10/337 • Number of events 10 • Baseline up to 30 Weeks
All randomized participants.
|
3.3%
11/336 • Number of events 12 • Baseline up to 30 Weeks
All randomized participants.
|
1.1%
2/183 • Number of events 2 • Baseline up to 30 Weeks
All randomized participants.
|
6.1%
5/82 • Number of events 5 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
23/750 • Number of events 25 • Baseline up to 30 Weeks
All randomized participants.
|
11.3%
38/337 • Number of events 47 • Baseline up to 30 Weeks
All randomized participants.
|
14.0%
47/336 • Number of events 56 • Baseline up to 30 Weeks
All randomized participants.
|
3.8%
7/183 • Number of events 7 • Baseline up to 30 Weeks
All randomized participants.
|
4.9%
4/82 • Number of events 4 • Baseline up to 30 Weeks
All randomized participants.
|
6.1%
5/82 • Number of events 5 • Baseline up to 30 Weeks
All randomized participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
13/750 • Number of events 13 • Baseline up to 30 Weeks
All randomized participants.
|
5.9%
20/337 • Number of events 21 • Baseline up to 30 Weeks
All randomized participants.
|
8.0%
27/336 • Number of events 29 • Baseline up to 30 Weeks
All randomized participants.
|
1.6%
3/183 • Number of events 3 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
0.00%
0/82 • Baseline up to 30 Weeks
All randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60