Trial Outcomes & Findings for Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy (NCT NCT01474538)
NCT ID: NCT01474538
Last Updated: 2014-03-20
Results Overview
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (\>8% or ≤8%) and participants.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
122 participants
Primary outcome timeframe
After 16 weeks of each treatment (Periods1 and 2)
Results posted on
2014-03-20
Participant Flow
Participant milestones
| Measure |
Insulin Lispro / Insulin Aspart
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
|
Insulin Aspart / Insulin Lispro
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
60
|
62
|
|
Treatment Period 1
Received at Least 1 Dose of Study Drug
|
60
|
62
|
|
Treatment Period 1
COMPLETED
|
57
|
58
|
|
Treatment Period 1
NOT COMPLETED
|
3
|
4
|
|
Treatment Period 2
STARTED
|
57
|
58
|
|
Treatment Period 2
Received at Least 1 Dose of Study Drug
|
57
|
58
|
|
Treatment Period 2
COMPLETED
|
51
|
56
|
|
Treatment Period 2
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Insulin Lispro / Insulin Aspart
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
|
Insulin Aspart / Insulin Lispro
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1
Death
|
1
|
0
|
|
Treatment Period 1
Physician Decision
|
1
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
1
|
3
|
|
Treatment Period 1
Protocol Violation
|
0
|
1
|
|
Treatment Period 2
Death
|
1
|
0
|
|
Treatment Period 2
Adverse Event
|
1
|
1
|
|
Treatment Period 2
Withdrawal by Subject
|
2
|
0
|
|
Treatment Period 2
Sponsor decision
|
1
|
0
|
|
Treatment Period 2
Physician Decision
|
0
|
1
|
|
Treatment Period 2
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy
Baseline characteristics by cohort
| Measure |
Insulin Lispro / Insulin Aspart
n=60 Participants
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
|
Insulin Aspart / Insulin Lispro
n=62 Participants
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.73 years
STANDARD_DEVIATION 10.41 • n=5 Participants
|
60.40 years
STANDARD_DEVIATION 9.72 • n=7 Participants
|
59.58 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
58 participants
n=5 Participants
|
61 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
62 participants
n=7 Participants
|
122 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 16 weeks of each treatment (Periods1 and 2)Population: All randomized participants who received at least 1 dose of study drug and had HbA1c measured at Week 16 of treatment Period 1 or 2. Participants were analyzed based on the treatment they received.
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (\>8% or ≤8%) and participants.
Outcome measures
| Measure |
Insulin Lispro
n=112 Participants
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
Insulin Aspart
n=111 Participants
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Glycosylated Hemoglobin A1C (HbA1c) at Endpoint
|
7.50 percentage of glycosylated hemoglobin
Standard Error 0.12
|
7.40 percentage of glycosylated hemoglobin
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Week 16 of each treatment (Periods 1 and 2)Population: All randomized participants who received at least 1 dose of study drug and had total daily insulin dose recorded during Treatment Period (TP) 1 or 2. If endpoint data was missing for a specific TP, last observation carried forward (LOCF) method was implemented for that respective TP. Participants were analyzed based on the treatment they received.
Total daily insulin dose was the average of the last 3 days total insulin dose immediately prior to the Week 16 (endpoint) visit of each treatment period. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (\>8% or ≤8%) and participants.
Outcome measures
| Measure |
Insulin Lispro
n=116 Participants
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
Insulin Aspart
n=117 Participants
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Total Daily Insulin Dose
|
80.41 units of insulin
Standard Error 4.78
|
80.69 units of insulin
Standard Error 4.77
|
SECONDARY outcome
Timeframe: Baseline through 16 weeks of each treatment (Periods 1 and 2)Population: All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.
A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\]. Least Squares (LS) means were adjusted for treatment, period, sequence, baseline hypoglycemic event rate, thiazolidinedione use (Yes/No) and baseline Hemoglobin A1c (HbA1c) (\>8% or ≤8%).
Outcome measures
| Measure |
Insulin Lispro
n=118 Participants
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
Insulin Aspart
n=119 Participants
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Rate of Hypoglycemic Events Per 30 Days
|
2.24 hypoglycemic events per 30 days
Standard Error 0.28
|
2.38 hypoglycemic events per 30 days
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, Week 16 of treatment Periods 1 and 2Population: All randomized participants who received at least 1 dose of study drug and had weight measured at baseline and Week 16 of Treatment Period 1 or 2. Participants were analyzed based on the treatment they received.
Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (\>8% or ≤8%), baseline weight and participants.
Outcome measures
| Measure |
Insulin Lispro
n=116 Participants
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
Insulin Aspart
n=117 Participants
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Change From Baseline in Weight
|
0.31 kilograms (kg)
Standard Error 0.53
|
0.89 kilograms (kg)
Standard Error 0.52
|
SECONDARY outcome
Timeframe: Baseline through 16 weeks of each treatment (Periods 1 and 2)Population: All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.
A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\]. The percentage of participants is the total number of participants experiencing hypoglycemic events divided by number of participants in the treatment arm multiplied by 100.
Outcome measures
| Measure |
Insulin Lispro
n=118 Participants
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
Insulin Aspart
n=119 Participants
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Percentage of Participants With Hypoglycemic Events
|
71.2 percentage of participants
|
74.8 percentage of participants
|
Adverse Events
Insulin Lispro
Serious events: 15 serious events
Other events: 59 other events
Deaths: 0 deaths
Insulin Aspart
Serious events: 14 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro
n=118 participants at risk
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
Insulin Aspart
n=119 participants at risk
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
2.5%
3/118 • Number of events 3
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
General disorders
Chest pain
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Infusion site abscess
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Pneumonia
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Investigations
International normalised ratio decreased
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Nervous system disorders
Hypoaesthesia
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/55
|
1.8%
1/55 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Vascular disorders
Deep vein thrombosis
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
Other adverse events
| Measure |
Insulin Lispro
n=118 participants at risk
Insulin lispro \[100 units/milliliter (U/mL)\] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
Insulin Aspart
n=119 participants at risk
Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Cardiac disorders
Cardiac flutter
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Cardiac disorders
Cardiomyopathy
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Ear and labyrinth disorders
Vertigo
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Endocrine disorders
Hypothyroidism
|
0.85%
1/118 • Number of events 1
|
1.7%
2/119 • Number of events 2
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Eye disorders
Iritis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Eye disorders
Lacrimation increased
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/118
|
1.7%
2/119 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
4.2%
5/118 • Number of events 5
|
1.7%
2/119 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Parotid gland inflammation
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
General disorders
Chest discomfort
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
General disorders
Chest pain
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
General disorders
Facial pain
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
General disorders
Fatigue
|
3.4%
4/118 • Number of events 4
|
3.4%
4/119 • Number of events 4
|
|
General disorders
Injection site haematoma
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
General disorders
Injection site nodule
|
1.7%
2/118 • Number of events 2
|
1.7%
2/119 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
General disorders
Oedema
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/118
|
1.7%
2/119 • Number of events 2
|
|
General disorders
Pyrexia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Immune system disorders
Multiple allergies
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Bacteraemia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Bronchitis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Ear infection
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 2
|
|
Infections and infestations
Fungal infection
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Gastroenteritis viral
|
2.5%
3/118 • Number of events 3
|
0.00%
0/119
|
|
Infections and infestations
Herpes zoster
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Influenza
|
1.7%
2/118 • Number of events 2
|
1.7%
2/119 • Number of events 2
|
|
Infections and infestations
Infusion site infection
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Labyrinthitis
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
5/118 • Number of events 5
|
4.2%
5/119 • Number of events 6
|
|
Infections and infestations
Onychomycosis
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Osteomyelitis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Post procedural infection
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
2.5%
3/118 • Number of events 3
|
3.4%
4/119 • Number of events 4
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/118 • Number of events 3
|
0.00%
0/119
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/118
|
2.5%
3/119 • Number of events 3
|
|
Infections and infestations
Viral infection
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Contusion
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Fall
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/118
|
1.7%
2/119 • Number of events 2
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/118
|
1.7%
2/119 • Number of events 2
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.7%
2/118 • Number of events 2
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Wound
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Investigations
Angiogram peripheral
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Investigations
Blood potassium increased
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Blood sodium decreased
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Investigations
Cardiac murmur
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Glycosylated haemoglobin increased
|
1.7%
2/118 • Number of events 2
|
1.7%
2/119 • Number of events 2
|
|
Investigations
International normalised ratio decreased
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Pulse pressure decreased
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Investigations
Transaminases increased
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.7%
2/118 • Number of events 2
|
1.7%
2/119 • Number of events 2
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/118
|
2.5%
3/119 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.85%
1/118 • Number of events 2
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
3/118 • Number of events 3
|
3.4%
4/119 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/118
|
1.7%
2/119 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.5%
3/118 • Number of events 3
|
2.5%
3/119 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
2/118 • Number of events 2
|
0.84%
1/119 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Carotid artery occlusion
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Diabetic neuropathy
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Nervous system disorders
Dizziness
|
1.7%
2/118 • Number of events 2
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/118
|
2.5%
3/119 • Number of events 3
|
|
Nervous system disorders
Migraine
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Psychiatric disorders
Depression
|
2.5%
3/118 • Number of events 3
|
2.5%
3/119 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Renal and urinary disorders
Incontinence
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/118
|
1.7%
2/119 • Number of events 2
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.6%
1/63 • Number of events 1
|
1.6%
1/64 • Number of events 2
|
|
Reproductive system and breast disorders
Prostatitis
|
1.8%
1/55 • Number of events 1
|
0.00%
0/55
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/63
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
2/118 • Number of events 2
|
1.7%
2/119 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
2/118 • Number of events 2
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/118
|
1.7%
2/119 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.85%
1/118 • Number of events 1
|
4.2%
5/119 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Surgical and medical procedures
Arterial repair
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Surgical and medical procedures
Foraminotomy
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Surgical and medical procedures
Gastric banding
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Surgical and medical procedures
Mole excision
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.00%
0/118
|
0.84%
1/119 • Number of events 1
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.85%
1/118 • Number of events 1
|
0.00%
0/119
|
|
Vascular disorders
Angiopathy
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.7%
2/118 • Number of events 2
|
1.7%
2/119 • Number of events 2
|
|
Vascular disorders
Intermittent claudication
|
0.85%
1/118 • Number of events 1
|
0.84%
1/119 • Number of events 1
|
|
Vascular disorders
Peripheral vascular disorder
|
1.7%
2/118 • Number of events 2
|
1.7%
2/119 • Number of events 2
|
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