A Comparison Study of Basal Bolus Therapies Together With... | NCT00666718

ID	Type	Description	Link
F3Z-EW-IOPJ	Other Identifier	Eli Lilly and Company

Status Module

Label	Type	Description	Intervention Names
Glargine	Active Comparator	Glargine plus Insulin Lispro (2-3 injections)	Drug: Insulin Glargine Drug: Insulin Lispro
ILPS	Experimental	Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)	Drug: Insulin Lispro Protamine Suspension (ILPS) Drug: Insulin Lispro

Name	Type	Description	Arm Group Labels	Other Names
Insulin Glargine	Drug	patient glucose-level dependent, injection, once daily in the evening, 24 weeks	Glargine

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24	Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.	Baseline, Week 24

Measure	Description	Time Frame
Change From Baseline in HbA1c at Week 12 and Week 24	LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.	Baseline, Week 12, Week 24
Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint

Eligibility Module

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.		Genk		3600

ID	Title	Description
FG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin
FG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00060.3± 8.07 BG00159.3± 8.36 BG00259.8± 8.22

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000101 BG001111 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG000186 BG001186 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Belgium

Title	Measurements
	BG0005 BG0012 BG002

Number of Insulin Injections/Inhalations Per Day

The number of insulin injections/inhalations is calculated as the sum of injections per day from the most recently applied insulins before randomization.

Number

Participants

Title

Denominators

Categories

1 Insulin Injection/Inhalation per day

Title	Measurements
	BG000104 BG001

Body Weight

Mean

Standard Deviation

kilograms (kg)

Title

Denominators

Categories

Title	Measurements
	BG00093.53± 17.168 BG00190.60± 17.075 BG002

Body Mass Index (BMI)

Body mass index is an estimate of body fat based on body weight divided by height squared.

Mean

Standard Deviation

kilograms per square meter (kg/m^2)

Title

Denominators

Categories

Title	Measurements
	BG00033.27± 5.040 BG00133.00± 5.004

Hemoglobin A1c (HbA1c)

Mean

Standard Deviation

Percent of glycosylated hemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.83± 0.896 BG0018.82± 0.895 BG002

Duration of Diabetes

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00012.7± 7.04 BG00111.8± 6.66 BG002

Previous Insulin Treatment

The dose is calculated as the total dose from the most recently applied previous insulins before randomization.

Mean

Standard Deviation

Units (IU)

Title

Denominators

Categories

Title	Measurements
	BG00036.9± 25.65 BG00137.6± 25.75

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) to Week 24

Least Squares Mean (LSMean) values reported in the table were controlled for treatment, country, and baseline HbA1c value.

Per-Protocol Population: All enrolled participants who were randomized and met the following criteria: no violations of Inclusion/Exclusion Criteria have not discontinued study prior to Week 24, compliant as assessed by investigator, and have not been on systemic glucocorticoid therapy for more than 14 consecutive days.

Posted

Least Squares Mean

Standard Error

Percent of Glycosylated Hemoglobin

Baseline, Week 24

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units	Counts
Participants	OG000163 OG001148

Title

Denominators

Categories

Title	Measurements
	OG000-1.28± 0.08 OG001-1.18± 0.09

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		ANCOVA				Mean Difference (Final Values)	0.10			2-Sided	95	-0.11	0.31				Yes	Non-Inferiority or Equivalence	Assuming a drop-out rate after randomization of approximately 15%, the remaining 160 patients in each treatment group should allow confirmation of noninferiority with no true treatment difference and a noninferiority limit of 0.4% using the upper limit of a 2-sided 95% confidence interval ("insulin lispro protamine suspension + insulin lispro" minus "insulin glargine+insulin lispro") at a significance level of 0.025 with 90% power.

Secondary

Change From Baseline in HbA1c at Week 12 and Week 24

LSMean values presented were controlled for treatment, country, baseline HbA1C value and week.

Full Analysis Set: All participants who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.

Posted

Least Squares Mean

95% Confidence Interval

Percent of Glycosylated Hemoglobin

Baseline, Week 12, Week 24

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint

Full Analysis Set: All patients who enrolled in this study, were randomized to 1 of the study treatments, and had at least 1 post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles.

Posted

Number

Percent of Participants

Week 24

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units	Counts
Participants	OG000

Secondary

7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint

LSMean values presented were controlled for treatment, country, and baseline HbA1C value. SMBG at morning pre-meal, morning postprandial, midday pre-meal, midday postprandial, evening pre-meal, evening postprandial, 0300 hours. Postprandial glucose is measured 2 hours after the start of the meal.

Posted

Least Squares Mean

Standard Error

millimoles per liter (mmol/L)

24 weeks

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units	Counts
Participants

Secondary

Glycemic Variability at Endpoint

LSMeans were controlled for treatment and country grouping (Mediterranean, rest of Europe). Glycemic variability was assessed as the standard deviations of 4 fasting SMBG samples, 4 post-breakfast measurements, 4 post-lunch measurements, 4 post-evening meal measurements.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 24

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units	Counts
Participants

Secondary

Rate Of All Self-reported Hypoglycemic Episodes

Rate of self-reported hypoglycemic episodes, all, non-nocturnal,and nocturnal, severe, documented ≤3.9 mmol/L and ≤3.0 mmol/L. Rate=episodes/30 days/patient/. Episode=any time a patient has a symptom associated with hypoglycemia or blood glucose level of ≤70 mg/dL,even if not associated with symptoms.Overall=any time post-randomization in the study period. Nocturnal=Episode between bedtime and waking. Non-Nocturnal=Episode between waking and bedtime.Severe:episode in which patient requires assistance,and has glucose <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or IV glucose.

Safety population - all participants who received at least one dose of study drug.

Posted

Least Squares Mean

Standard Error

episode/30 days/participant

Baseline through Week 24

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units

Secondary

Percentage of Participants With Self-Reported Hypoglycemic Episodes

Episode=any time a patient feels that he/she is experiencing a sign or symptom associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if not associated with signs,symptoms, or treatment. Overall=any time post-randomization visits in the study period. Nocturnal=Episode that occurs between bedtime and waking. Non-Nocturnal=Episode occurring between waking and bedtime. Severe=episode with symptoms of neuroglycopenia in which patient requires assistance,and has blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.

Safety population - all participants who received at least one dose of study drug.

Posted

Number

percentage of participants

Baseline through Week 24

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units

Secondary

Number of Participants With Adverse Events (AE)

A listing of adverse events is located in the Reported Adverse Event module.

Safety population - all participants who received at least one dose of study drug.

Posted

Number

participants

Baseline through Week 24

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units	Counts
Participants	OG000

Secondary

Change in Body Weight From Baseline to Week 24

LSMean values presented were controlled for treatment, country, and baseline HbA1C value.

Posted

Least Squares Mean

Standard Error

Kilograms (kg)

Baseline, Week 24

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units	Counts
Participants

Secondary

Total Daily Insulin Dose at Endpoint

LSMean values presented were controlled for treatment, country, and baseline HbA1C value.

Posted

Least Squares Mean

Standard Error

Units

Week 24

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units	Counts
Participants	OG000

Secondary

Number of Injections of Insulin at Week 24

Posted

Number

Participants

Week 24

ID	Title	Description
OG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin. Participant glucose-level dependent, injection, once daily in the evening, 24 weeks
OG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin. Patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected187 at risk EG0011 events1 affected187 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected187 at risk EG0010 events0 affected187 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected187 at risk EG0010 events0 affected187 at risk
Coronary artery disease	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected187 at risk EG0010 events0 affected187 at risk
Coronary artery perforation	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected187 at risk EG0010 events0 affected187 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	This event resulted in death.	EG0001 events1 affected187 at risk EG0010 events0 affected187 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected187 at risk EG0010 events0 affected187 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Impaired healing	General disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Oedema mucosal	General disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Bronchopneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected187 at risk EG0010 events0 affected187 at risk
Injection site abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected187 at risk EG0010 events0 affected187 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected187 at risk EG0010 events0 affected187 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected187 at risk EG0010 events0 affected187 at risk
Renal colic	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Physiotherapy	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Arterial stenosis	Vascular disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected187 at risk EG0011 events1 affected187 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected187 at risk EG0010 events0 affected187 at risk
Diabetic retinopathy	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0013 events3 affected187 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected187 at risk EG0012 events2 affected187 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0008 events8 affected187 at risk EG0014 events3 affected187 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0006 events5 affected187 at risk EG0011 events1 affected187 at risk
Toothache	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected187 at risk EG0016 events4 affected187 at risk
Chest discomfort	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected187 at risk EG0010 events0 affected187 at risk
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0013 events2 affected187 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected187 at risk EG0010 events0 affected187 at risk
Cystitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected187 at risk EG0011 events1 affected187 at risk
Influenza	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected187 at risk EG0014 events4 affected187 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected187 at risk EG0010 events0 affected187 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00017 events12 affected187 at risk EG00112 events10 affected187 at risk
Pharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0012 events2 affected187 at risk
Pulpitis dental	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected187 at risk EG0010 events0 affected187 at risk
Rhinitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected187 at risk EG0013 events3 affected187 at risk
Sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected187 at risk EG0010 events0 affected187 at risk
Tonsillitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected187 at risk EG0011 events1 affected187 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0012 events2 affected187 at risk
Viral infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0007 events5 affected187 at risk EG0017 events7 affected187 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0007 events5 affected187 at risk EG0013 events3 affected187 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0007 events6 affected187 at risk EG0016 events3 affected187 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0013 events3 affected187 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected187 at risk EG0010 events0 affected187 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected187 at risk EG0011 events1 affected187 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00020 events11 affected187 at risk EG00139 events9 affected187 at risk
Sciatica	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected187 at risk EG0010 events0 affected187 at risk
Tremor	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected187 at risk EG0010 events0 affected187 at risk
Anxiety	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected187 at risk EG0010 events0 affected187 at risk
Depression	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0012 events2 affected187 at risk
Insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0007 events2 affected187 at risk EG0010 events0 affected187 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0012 events2 affected187 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0009 events7 affected187 at risk EG0015 events4 affected187 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected187 at risk EG0013 events3 affected187 at risk
Cataract operation	Surgical and medical procedures	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected187 at risk EG0010 events0 affected187 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected187 at risk EG0014 events4 affected187 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D049528	Insulin, Long-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
D061266	Insulin, Short-Acting

ID	Title	Description
BG000	Glargine	Glargine plus Insulin Lispro (2-3 injections) plus metformin
BG001	ILPS	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin
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	Glargine/Lispro	Glargine plus Insulin Lispro (2-3 injections) plus metformin			9	187	81	187
EG001	Lispro/Metformin	Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin			14	187	65	187