Safety and Efficacy Study of Insulin Lispro Versus Insuli... | NCT01474538

ID	Type	Description	Link
F3Z-MC-IOQH	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Insulin Lispro, then Insulin Aspart	Active Comparator	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.	Drug: Insulin Lispro
Insulin Aspart, then Insulin Lispro	Active Comparator	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.	Drug: Insulin Aspart

Name	Type	Description	Arm Group Labels	Other Names
Insulin Lispro	Drug	Insulin lispro (100 U/mL) administered by CSII pump	Insulin Lispro, then Insulin Aspart

Measure	Description	Time Frame
Glycosylated Hemoglobin A1C (HbA1c) at Endpoint	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.	After 16 weeks of each treatment (Periods1 and 2)

Measure	Description	Time Frame
Total Daily Insulin Dose	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.	Week 16 of each treatment (Periods 1 and 2)

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-877-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT -5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Little Rock	Arkansas	72205

ID	Title	Description
FG000	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.
FG001

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00060 BG00162 BG002122

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Glycosylated Hemoglobin A1C (HbA1c) at Endpoint

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.

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.

Posted

Least Squares Mean

Standard Error

percentage of glycosylated hemoglobin

After 16 weeks of each treatment (Periods1 and 2)

ID	Title	Description
OG000	Insulin Lispro	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.
OG001	Insulin Aspart	Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.

Units	Counts
Participants	OG000112 OG001111

Title

Denominators

Categories

Title	Measurements
	OG0007.50± 0.12 OG0017.40± 0.12

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis				LS Mean difference	0.10			2-Sided	95	-0.002	0.210				Yes	Non-Inferiority or Equivalence	If the upper limit of the 95% confidence interval (CI) was below 0.4%, lispro was declared non-inferior to aspart.

Secondary

Total Daily Insulin Dose

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.

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.

Posted

Least Squares Mean

Standard Error

units of insulin

Week 16 of each treatment (Periods 1 and 2)

ID	Title	Description
OG000	Insulin Lispro	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.
OG001	Insulin Aspart	Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.

Units	Counts

Secondary

Rate of Hypoglycemic Events Per 30 Days

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%).

All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.

Posted

Least Squares Mean

Standard Error

hypoglycemic events per 30 days

Baseline through 16 weeks of each treatment (Periods 1 and 2)

ID	Title	Description
OG000	Insulin Lispro	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.
OG001	Insulin Aspart	Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.

Units	Counts

Secondary

Change From Baseline in Weight

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.

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.

Posted

Least Squares Mean

Standard Error

kilograms (kg)

Baseline, Week 16 of treatment Periods 1 and 2

ID	Title	Description
OG000	Insulin Lispro	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.
OG001	Insulin Aspart	Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Hypoglycemic Events

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.

All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.

Posted

Number

percentage of participants

Baseline through 16 weeks of each treatment (Periods 1 and 2)

ID	Title	Description
OG000	Insulin Lispro	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.
OG001	Insulin Aspart	Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Coronary artery disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0003 events3 affected118 at risk EG0011 events1 affected119 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	Event resulted in death in Insulin Aspart group.	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Chest pain	General disorders	MedDRA 15.1	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Infusion site abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	Event resulted in death.	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
International normalised ratio decreased	Investigations	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Convulsion	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Syncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 15.1	Systematic Assessment		EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment		EG0000 events0 affected55 at risk EG0011 events1 affected55 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 15.1	Systematic Assessment		EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Cardiac flutter	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Eustachian tube dysfunction	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Hypothyroidism	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events2 affected119 at risk
Conjunctivitis	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Iritis	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Lacrimation increased	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected119 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected118 at risk EG0012 events2 affected119 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Parotid gland inflammation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Chest discomfort	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Facial pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Fatigue	General disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected118 at risk EG0014 events4 affected119 at risk
Injection site haematoma	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Injection site nodule	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events2 affected119 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Oedema	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Oedema peripheral	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected119 at risk
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Multiple allergies	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Seasonal allergy	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Bronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Ear infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0012 events1 affected119 at risk
Fungal infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected118 at risk EG0010 events0 affected119 at risk
Herpes zoster	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Influenza	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events2 affected119 at risk
Infusion site infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Labyrinthitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected118 at risk EG0016 events5 affected119 at risk
Onychomycosis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Osteomyelitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Post procedural infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Sinusitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected118 at risk EG0014 events4 affected119 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Staphylococcal infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Tooth abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Tooth infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected118 at risk EG0010 events0 affected119 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0013 events3 affected119 at risk
Viral infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected119 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected119 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected119 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Angiogram peripheral	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Blood potassium increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Blood sodium decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Cardiac murmur	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Catheterisation cardiac	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events2 affected119 at risk
International normalised ratio decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Pulse pressure decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Transaminases increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events2 affected119 at risk
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0013 events3 affected119 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected118 at risk EG0010 events0 affected119 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected118 at risk EG0014 events4 affected119 at risk
Bunion	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected119 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected118 at risk EG0013 events3 affected119 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected119 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected119 at risk
Essential tremor	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0013 events3 affected119 at risk
Migraine	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Paraesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Depression	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected118 at risk EG0013 events3 affected119 at risk
Insomnia	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Dysuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Incontinence	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected119 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Renal failure	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected63 at risk EG0012 events1 affected64 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected55 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected63 at risk EG0011 events1 affected64 at risk
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events2 affected119 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0011 events1 affected119 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0012 events2 affected119 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0015 events5 affected119 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Arterial repair	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Coronary angioplasty	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Foraminotomy	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Gastric banding	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Mole excision	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Rotator cuff repair	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected118 at risk EG0011 events1 affected119 at risk
Spinal fusion surgery	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Spinal laminectomy	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0010 events0 affected119 at risk
Angiopathy	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Flushing	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events2 affected119 at risk
Intermittent claudication	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected118 at risk EG0011 events1 affected119 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected118 at risk EG0012 events2 affected119 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Insulin Lispro	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.			15	118	59	118
EG001	Insulin Aspart	Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.			14	119	62	119