Trial Outcomes & Findings for Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use (NCT NCT01134107)

NCT ID: NCT01134107

Last Updated: 2013-04-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 133 participants
• Primary outcome timeframe: Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)
• Results posted on: 2013-04-11

Participant Flow

Participant milestones

Measure	Lispro 6D/Aspart 6D Insulin Lispro 6 Day (6D) administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.	Aspart 6D/Lispro 6D Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
Period 1-First Treatment Intervention STARTED	67	66
Period 1-First Treatment Intervention Received at Least One Dose of Study Drug	66	66
Period 1-First Treatment Intervention COMPLETED	61	61
Period 1-First Treatment Intervention NOT COMPLETED	6	5
Period 2-Second Treatment Intervention STARTED	61	61
Period 2-Second Treatment Intervention COMPLETED	57	61
Period 2-Second Treatment Intervention NOT COMPLETED	4	0

Reasons for withdrawal

Measure	Lispro 6D/Aspart 6D Insulin Lispro 6 Day (6D) administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.	Aspart 6D/Lispro 6D Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
Period 1-First Treatment Intervention Adverse Event	1	0
Period 1-First Treatment Intervention Entry Criteria Not Met	1	1
Period 1-First Treatment Intervention Withdrawal by Subject	3	4
Period 1-First Treatment Intervention Physician Decision	1	0
Period 2-Second Treatment Intervention Withdrawal by Subject	2	0
Period 2-Second Treatment Intervention Physician Decision	1	0
Period 2-Second Treatment Intervention Sponsor Decision	1	0

Baseline Characteristics

Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use

Baseline characteristics by cohort

Measure	Lispro 6D/Aspart 6D n=67 Participants Insulin Lispro 6D administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.	Aspart 6D/Lispro 6D n=66 Participants Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.	Total n=133 Participants Total of all reporting groups
Age Continuous	40.71 years STANDARD_DEVIATION 11.91 • n=5 Participants	44.73 years STANDARD_DEVIATION 12.96 • n=7 Participants	42.70 years STANDARD_DEVIATION 12.56 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	45 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized White	67 participants n=5 Participants	66 participants n=7 Participants	133 participants n=5 Participants
Region of Enrollment France	15 participants n=5 Participants	14 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment Hungary	33 participants n=5 Participants	37 participants n=7 Participants	70 participants n=5 Participants
Region of Enrollment Germany	19 participants n=5 Participants	15 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)

Population: All randomized participants who completed at least one post-randomization visit. Those included in the primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.

Outcome measures

Measure	Insulin Lispro 6D n=118 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=118 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use	8.83 millimoles per liter (mmol/L) Standard Deviation 1.55	8.43 millimoles per liter (mmol/L) Standard Deviation 1.97

SECONDARY outcome

Timeframe: Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period

Population: All randomized participants who completed at least one post-randomization visit and one SMBG measurement on a Day 6, or Day 2 depending on the analysis, for the respective treatment arm: insulin lispro 6D and insulin aspart 6D.

Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D.

Outcome measures

Measure	Insulin Lispro 6D n=126 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=126 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Mean SMBG SMBG Days 1-6 (N=124, 124)	8.70 millimoles per liter (mmol/L) Standard Deviation 2.51	8.47 millimoles per liter (mmol/L) Standard Deviation 2.46
Mean SMBG SMBG Day 2	8.56 millimoles per liter (mmol/L) Standard Deviation 2.51	8.40 millimoles per liter (mmol/L) Standard Deviation 2.47
Mean SMBG SMBG Day 6 (N=124, 124)	8.93 millimoles per liter (mmol/L) Standard Deviation 2.68	8.57 millimoles per liter (mmol/L) Standard Deviation 2.64

SECONDARY outcome

Timeframe: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Population: All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.

Outcome measures

Measure	Insulin Lispro 6D n=119 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=119 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Mean Daily Insulin Dose (Total, Basal, and Bolus) Daily Total Insulin	32.90 Units (U) of insulin Standard Deviation 8.43	32.48 Units (U) of insulin Standard Deviation 8.42
Mean Daily Insulin Dose (Total, Basal, and Bolus) Daily Basal Insulin	17.83 Units (U) of insulin Standard Deviation 5.26	17.71 Units (U) of insulin Standard Deviation 5.27
Mean Daily Insulin Dose (Total, Basal, and Bolus) Daily Bolus Insulin (N=116, 117)	16.26 Units (U) of insulin Standard Deviation 6.21	16.09 Units (U) of insulin Standard Deviation 6.23

SECONDARY outcome

Timeframe: Baseline, endpoint for each 12-week treatment period

Population: All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.

Outcome measures

Measure	Insulin Lispro 6D n=127 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=126 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values	-0.16 percentage of HbA1c Standard Deviation 0.54	-0.31 percentage of HbA1c Standard Deviation 0.50

SECONDARY outcome

Timeframe: Endpoint for each 12-week treatment period

Population: All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.

Outcome measures

Measure	Insulin Lispro 6D n=127 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=126 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7% HbA1c ≤6.5%	18 participants	21 participants
Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7% HbA1c <7%	38 participants	56 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, endpoint for each 12-week treatment period

Population: All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.

Outcome measures

Measure	Insulin Lispro 6D n=119 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=115 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) Total Insulin Dose	5.21 Units (U) of insulin Standard Deviation 8.94	4.97 Units (U) of insulin Standard Deviation 7.57
Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) Basal Insulin Dose	2.34 Units (U) of insulin Standard Deviation 3.51	1.91 Units (U) of insulin Standard Deviation 3.80
Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) Bolus Insulin Dose (N=112, 112)	2.19 Units (U) of insulin Standard Deviation 5.58	1.80 Units (U) of insulin Standard Deviation 4.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Population: All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.

A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating

Outcome measures

Measure	Insulin Lispro 6D n=124 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=124 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Percentage of Participants Having a Hyperglycemic Episode	97.6 percentage of participants	98.4 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Population: All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.

Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter [mg/dL] (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.

Outcome measures

Measure	Insulin Lispro 6D n=124 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=124 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Hyperglycemic Episode Rate Per 30 Days	15.47 hyperglycemic episodes per 30 days Standard Deviation 9.25	14.23 hyperglycemic episodes per 30 days Standard Deviation 10.19

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Population: All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.

Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.

Outcome measures

Measure	Insulin Lispro 6D n=127 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=127 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Percentage of Participants With Pump Complications Pump Complication: Premature Reservoir Change	42.5 percentage of participants	44.1 percentage of participants
Percentage of Participants With Pump Complications Pump Complication: Premature Infusion Set Change	74.8 percentage of participants	70.9 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 1-6 for each reservoir cycle throughout each 12-week treatment period

Population: All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.

Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.

Outcome measures

Measure	Insulin Lispro 6D n=127 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=127 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Pump Complications Rate Per 30 Days Pump Complication: Premature Reservoir Change	0.42 pump complications per 30 days Standard Deviation 0.93	0.45 pump complications per 30 days Standard Deviation 1.03
Pump Complications Rate Per 30 Days Pump Complication: Premature Infusion Set Change	1.01 pump complications per 30 days Standard Deviation 1.41	1.10 pump complications per 30 days Standard Deviation 1.47

OTHER_PRE_SPECIFIED outcome

Timeframe: All days for each reservoir cycle throughout each 12-week treatment period

Population: All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.

A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).

All Reported Hypoglycemic Episodes are defined as an event which is associated with

1. reported signs and symptoms of hypoglycemia, and/or

2. a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)

Outcome measures

Measure	Insulin Lispro 6D n=127 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=127 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Percentage of Participants Having a Hypoglycemic Episode Documented Hypoglycemic Episodes	91.3 percentage of participants	93.7 percentage of participants
Percentage of Participants Having a Hypoglycemic Episode All Reported Hypoglycemic Episodes	99.2 percentage of participants	99.2 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: All days for each reservoir cycle throughout each 12-week treatment period

Population: All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.

All Reported Hypoglycemic Episodes are defined as an event which is associated with

1. reported signs and symptoms of hypoglycemia, and/or

2. a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)

Outcome measures

Measure	Insulin Lispro 6D n=127 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=127 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Hypoglycemic Episode Rate Per 30 Days	16.94 hypoglycemic episodes per 30 days Standard Deviation 10.69	18.90 hypoglycemic episodes per 30 days Standard Deviation 11.58

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, endpoint for each 12-week treatment period

Population: All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.

Outcome measures

Measure	Insulin Lispro 6D n=126 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=123 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Change From Baseline to 12 Week Endpoint for Each Treatment in Weight	-0.04 kilograms (kg) Standard Deviation 2.25	0.56 kilograms (kg) Standard Deviation 2.15

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, endpoint for each 12-week treatment period

Population: All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.

Outcome measures

Measure	Insulin Lispro 6D n=126 Participants Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=121 Participants Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure Systolic Blood Pressure (SBP)	-2.25 millimeters of mercury (mmHg) Standard Deviation 14.71	-1.36 millimeters of mercury (mmHg) Standard Deviation 12.12
Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure Diastolic Blood Pressure (DBP)	-1.61 millimeters of mercury (mmHg) Standard Deviation 10.36	-1.57 millimeters of mercury (mmHg) Standard Deviation 9.13

Adverse Events

Insulin Lispro 6D

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Insulin Aspart 6D

Serious events: 7 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Insulin Lispro 6D n=127 participants at risk Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=127 participants at risk Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Metabolism and nutrition disorders Diabetic ketoacidosis	0.79% 1/127 • Number of events 1	0.00% 0/127
Metabolism and nutrition disorders Hypoglycaemia	1.6% 2/127 • Number of events 2	5.5% 7/127 • Number of events 8

Other adverse events

Measure	Insulin Lispro 6D n=127 participants at risk Insulin Lispro 6D administered by infusion pump for 12 week treatment period	Insulin Aspart 6D n=127 participants at risk Insulin Aspart 6D administered by infusion pump for 12 week treatment period
Blood and lymphatic system disorders Haemorrhagic anaemia	0.79% 1/127 • Number of events 1	0.00% 0/127
Blood and lymphatic system disorders Iron deficiency anaemia	0.79% 1/127 • Number of events 1	0.00% 0/127
Gastrointestinal disorders Abdominal pain upper	0.00% 0/127	0.79% 1/127 • Number of events 1
Gastrointestinal disorders Diarrhoea	0.00% 0/127	0.79% 1/127 • Number of events 1
Gastrointestinal disorders Dyspepsia	0.79% 1/127 • Number of events 1	0.00% 0/127
Gastrointestinal disorders Toothache	0.79% 1/127 • Number of events 1	1.6% 2/127 • Number of events 2
General disorders Device occlusion	0.79% 1/127 • Number of events 2	0.79% 1/127 • Number of events 2
General disorders Pyrexia	0.79% 1/127 • Number of events 1	0.79% 1/127 • Number of events 1
Immune system disorders Hypersensitivity	1.6% 2/127 • Number of events 2	0.00% 0/127
Immune system disorders Seasonal allergy	0.00% 0/127	0.79% 1/127 • Number of events 1
Infections and infestations Acute tonsillitis	0.00% 0/127	0.79% 1/127 • Number of events 2
Infections and infestations Bronchitis	0.00% 0/127	2.4% 3/127 • Number of events 3
Infections and infestations Cystitis	0.00% 0/127	0.79% 1/127 • Number of events 1
Infections and infestations Ear infection	0.79% 1/127 • Number of events 1	0.00% 0/127
Infections and infestations Gastroenteritis	2.4% 3/127 • Number of events 3	1.6% 2/127 • Number of events 2
Infections and infestations Herpes zoster	0.79% 1/127 • Number of events 1	0.00% 0/127
Infections and infestations Influenza	2.4% 3/127 • Number of events 3	2.4% 3/127 • Number of events 3
Infections and infestations Nasopharyngitis	7.9% 10/127 • Number of events 10	4.7% 6/127 • Number of events 6
Infections and infestations Pharyngitis	0.79% 1/127 • Number of events 1	0.00% 0/127
Infections and infestations Rash pustular	0.79% 1/127 • Number of events 1	0.79% 1/127 • Number of events 1
Infections and infestations Rhinitis	0.00% 0/127	0.79% 1/127 • Number of events 1
Infections and infestations Sinusitis	0.00% 0/127	0.79% 1/127 • Number of events 1
Infections and infestations Tracheobronchitis	0.00% 0/127	0.79% 1/127 • Number of events 1
Infections and infestations Urinary tract infection	0.79% 1/127 • Number of events 1	1.6% 2/127 • Number of events 2
Infections and infestations Uterine infection	0.79% 1/127 • Number of events 1	0.00% 0/127
Injury, poisoning and procedural complications Foot fracture	0.79% 1/127 • Number of events 1	0.79% 1/127 • Number of events 1
Injury, poisoning and procedural complications Joint dislocation	0.79% 1/127 • Number of events 1	0.00% 0/127
Injury, poisoning and procedural complications Open wound	0.79% 1/127 • Number of events 1	0.79% 1/127 • Number of events 1
Metabolism and nutrition disorders Iron deficiency	0.79% 1/127 • Number of events 1	0.00% 0/127
Musculoskeletal and connective tissue disorders Arthralgia	0.79% 1/127 • Number of events 1	0.79% 1/127 • Number of events 1
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/127	0.79% 1/127 • Number of events 1
Nervous system disorders Carpal tunnel syndrome	0.79% 1/127 • Number of events 1	0.79% 1/127 • Number of events 1
Nervous system disorders Migraine	0.79% 1/127 • Number of events 1	0.00% 0/127
Nervous system disorders Paraesthesia	0.79% 1/127 • Number of events 1	0.00% 0/127
Renal and urinary disorders Microalbuminuria	0.00% 0/127	0.79% 1/127 • Number of events 1
Reproductive system and breast disorders Menorrhagia	0.79% 1/127 • Number of events 1	0.00% 0/127
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/127	1.6% 2/127 • Number of events 2
Respiratory, thoracic and mediastinal disorders Cough	0.79% 1/127 • Number of events 1	0.00% 0/127
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.79% 1/127 • Number of events 1	0.00% 0/127
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/127	0.79% 1/127 • Number of events 1
Skin and subcutaneous tissue disorders Lipohypertrophy	0.79% 1/127 • Number of events 1	0.00% 0/127
Skin and subcutaneous tissue disorders Skin fissures	0.79% 1/127 • Number of events 1	0.79% 1/127 • Number of events 1
Skin and subcutaneous tissue disorders Subcutaneous nodule	0.00% 0/127	1.6% 2/127 • Number of events 2
Surgical and medical procedures Atherectomy	0.79% 1/127 • Number of events 1	0.00% 0/127
Surgical and medical procedures Cataract operation	0.00% 0/127	0.79% 1/127 • Number of events 1
Surgical and medical procedures Injection	0.79% 1/127 • Number of events 1	0.00% 0/127
Vascular disorders Hypertension	0.00% 0/127	0.79% 1/127 • Number of events 1
Vascular disorders Phlebitis	0.00% 0/127	0.79% 1/127 • Number of events 1

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60