A Study on the Effect of 2 Pen Devices on HbA1c | NCT00985712

ID	Type	Description	Link
H9D-SB-ITAE	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
HumaPen Luxura	Experimental	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks	Drug: Insulin Lispro Drug: Huminsulin Regular Device: HumaPen Luxura
HumaPen Memoir	Experimental	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks	Drug: Insulin Lispro Drug: Huminsulin Regular Device: HumaPen Memoir

Name	Type	Description	Arm Group Labels	Other Names
Insulin Lispro	Drug	subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks	HumaPen Luxura HumaPen Memoir

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint	HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c.	Baseline, Week 24

Measure	Description	Time Frame
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint		Week 24
Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint	IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 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.		Aschaffenburg		63739

ID	Title	Description
FG000	HumaPen Luxura	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
FG001	HumaPen Memoir	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

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

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint

HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c.

Participants in full analysis population set with missing values accounted for using mixed model repeated measures (MMRM).

Posted

Least Squares Mean

95% Confidence Interval

percentage of glycosylated hemoglobin

Baseline, Week 24

ID	Title	Description
OG000	HumaPen Luxura	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
OG001	HumaPen Memoir	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

Units	Counts
Participants	OG000128 OG001129

Title

Denominators

Categories

Title	Measurements
	OG000-0.48(-0.64 to -0.32) OG001-0.43(-0.59 to -0.28)

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	Superiority criterion is met if the upper limit of Confidence Interval (CI) is below zero.	Mixed Models Analysis	The model details are given in the section of Measure Description.	0.6692		LS Mean Difference (Final Values)	0.05	Standard Error of the Mean	0.11	2-Sided	95	-0.17	0.26				No	Superiority or Other

Secondary

Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint

Participants in full analysis population set who had Week 24 measurements.

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	HumaPen Luxura	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
OG001	HumaPen Memoir	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

Units	Counts
Participants	OG000

Secondary

Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint

IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score.

Participants in full analysis population set who had Week 24 measurements.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Week 24

ID	Title	Description
OG000	HumaPen Luxura	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
OG001	HumaPen Memoir	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

Units	Counts
Participants

Secondary

30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24

Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter [mg/dL]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.

Randomized participants who took at least one dose of study drug with post-baseline hypoglycemia follow-up.

Posted

Mean

Standard Deviation

number of events per 30 days

Baseline through Week 24

ID	Title	Description
OG000	HumaPen Luxura	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
OG001	HumaPen Memoir	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

Units	Counts
Participants	OG000

Secondary

30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24

Hyperglycemic episode is defined as blood glucose measurement >18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.

Randomized participants who took at least one dose of study drug with post-baseline hyperglycemia follow-up.

Posted

Mean

Standard Deviation

number of events per 30 days

Baseline through Week 24

ID	Title	Description
OG000	HumaPen Luxura	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
OG001	HumaPen Memoir	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Cystitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0010 events0 affected130 at risk
Salpingo-oophoritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0012 events2 affected130 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0011 events1 affected130 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0010 events0 affected130 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0012 events1 affected130 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0010 events0 affected130 at risk
Cataract	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Conjunctivitis	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Glaucoma	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0012 events2 affected130 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Toothache	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0011 events1 affected130 at risk
Injection site pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Oedema	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0010 events0 affected130 at risk
Acute sinusitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0011 events1 affected130 at risk
Cystitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0010 events0 affected130 at risk
Ear infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0012 events1 affected130 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Fungal infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0012 events2 affected130 at risk
Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Influenza	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0011 events1 affected130 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00018 events15 affected131 at risk EG00113 events12 affected130 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Scarlet fever	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Sinobronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Tonsillitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0011 events1 affected130 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 events3 affected131 at risk EG0012 events2 affected130 at risk
Viral infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0011 events1 affected130 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0011 events1 affected130 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0011 events1 affected130 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0010 events0 affected130 at risk
Liver function test abnormal	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0012 events2 affected130 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0011 events1 affected130 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0011 events1 affected130 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0003 events3 affected131 at risk EG0010 events0 affected130 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Headache	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0010 events0 affected130 at risk
Migraine	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Polyneuropathy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Anxiety	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Burnout syndrome	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Depression	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0010 events0 affected130 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Nephropathy	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Renal impairment	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0011 events1 affected130 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Lipodystrophy acquired	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected131 at risk EG0010 events0 affected130 at risk
Lipohypertrophy	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Haematoma	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected131 at risk EG0010 events0 affected130 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected131 at risk EG0011 events1 affected130 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune 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
BG000	HumaPen Luxura	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
BG001	HumaPen Memoir	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HumaPen Luxura	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks			7	131	52	131
EG001	HumaPen Memoir	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks			8	130	50	130