Comparison of Two Approaches to Insulin Therapy in Patien... | NCT00377858

ID	Type	Description	Link
F3Z-MC-IOOX

Label	Type	Description	Intervention Names
Insulin Lispro Mid Mixture	Experimental	Insulin lispro mid mixture (MM) up to three times a day (TID)	Drug: Insulin lispro mid mixture (MM)
Insulin Glargine	Active Comparator	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.	Drug: Insulin glargine

Name	Type	Description	Arm Group Labels	Other Names
Insulin lispro mid mixture (MM)	Drug	Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks	Insulin Lispro Mid Mixture

Measure	Description	Time Frame
Hemoglobin A1c (HbA1c) at 36 Week Endpoint	Level of hemoglobin A1c at endpoint.	36 weeks

Measure	Description	Time Frame
Hemoglobin A1c (HbA1c) at Interval Visits	Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.	12, 24, and 36 weeks
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint

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.		Keswick	South Australia	5035

PubMed Identifier	Type	Citation	Retractions
23489710	Derived	Hayes RP, Curtis B, Ilag L, Nelson DR, Wong M, Funnell M. Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy. J Diabetes. 2013 Sep;5(3):358-67. doi: 10.1111/1753-0407.12037. Epub 2013 May 28.

ID	Title	Description
FG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
FG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

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

Hemoglobin A1c (HbA1c) at 36 Week Endpoint

Level of hemoglobin A1c at endpoint.

Number of participants in the per-protocol population. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

percent HbA1c

36 weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Units	Counts
Participants	OG000188 OG001195

Title

Denominators

Categories

Title	Measurements
	OG0007.66± 0.37 OG0017.49± 0.36

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	Assuming 15% drop-out rate after randomization, remaining 213 patients in each treatment group would allow confirmation of noninferiority with no treatment difference and a noninferiority limit of 0.3% using upper limit of 2-sided confidence interval at significance level of 0.05 with 80% power.	ANCOVA	ANCOVA Model: Variable=Treatment + Baseline HbA1c Stratum + Sulfonylurea stratum + Country + Baseline HbA1c Stratum.	0.097		Mean Difference (Net)	0.17				95	-0.03	0.37			The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for (Insulin Lispro Mid Mixture minus Insulin Glargine).	Yes

Secondary

Hemoglobin A1c (HbA1c) at Interval Visits

Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.

Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.

Posted

Least Squares Mean

Standard Error

percent HbA1c

12, 24, and 36 weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint

Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).

Posted

Number

percentage of participants

12-24-36 weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Units	Counts
Participants	OG000

Secondary

7-point Self-monitored Blood Glucose Profiles

Actual daily mean blood glucose levels at specified time points.

Posted

Least Squares Mean

Standard Error

millimoles per Liter (mmol/L)

Baseline, 12-24-36 weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Units	Counts
Participants	OG000

Secondary

Glycemic Variability

Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.

Posted

Least Squares Mean

Standard Error

millimoles per liter (mmol/L)

Baseline, 12-24-36 weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Units	Counts
Participants

Secondary

Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia

Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level <70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.

Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.

Posted

Number

participants

Baseline to 36 Weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Secondary

30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)

Posted

Mean

Standard Deviation

hypoglycemic event per 30 days

Baseline to 36 Weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Secondary

Number of Patients With at Least One Severe Hypoglycemia Episode

Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose <2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.

Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.

Posted

Number

participants

Baseline to 36 Weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Units	Counts
Participants

Secondary

Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial

Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day [U/kg/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.

Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

U/kg/day

36 Weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Units	Counts
Participants

Secondary

Endpoint Insulin Dose; Total, Basal, and Prandial

Total daily insulin dose (Units of insulin per day [U/day]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.

Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

U/day

36 Weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Units	Counts
Participants

Secondary

Number of Insulin Injections Per Day

Posted

Least Squares Mean

Standard Error

insulin injections

Weeks 12, 24, 30, 36

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Absolute Body Weight at 36 Week Endpoint

Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.

Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

kilograms

Baseline, 36 Weeks

ID	Title	Description
OG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
OG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Angina pectoris	Cardiac disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Cardiac failure	Cardiac disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Coronary artery disease	Cardiac disorders	MedDRA 11.0	Systematic Assessment	Death (insulin glargine patient)	EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Myocardial infarction	Cardiac disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Glaucoma	Eye disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Gastritis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Death	General disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Ilium fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Hypoglycaemic seizure	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Convulsion	Nervous system disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	Death (insulin glargine patient)	EG0001 events1 affected239 at risk EG0011 events1 affected240 at risk
Angiopathy	Vascular disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk
Arterial disorder	Vascular disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Extremity necrosis	Vascular disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Phlebitis	Vascular disorders	MedDRA 11.0	Systematic Assessment		EG0001 events1 affected239 at risk EG0010 events0 affected240 at risk
Vasculitis	Vascular disorders	MedDRA 11.0	Systematic Assessment		EG0000 events0 affected239 at risk EG0011 events1 affected240 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected239 at risk EG0014 events3 affected240 at risk
Diabetic retinopathy	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected239 at risk EG0014 events4 affected240 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0011 events1 affected240 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events3 affected239 at risk EG0010 events0 affected240 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0009 events7 affected239 at risk EG0019 events8 affected240 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events3 affected239 at risk EG0013 events3 affected240 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0006 events6 affected239 at risk EG0012 events2 affected240 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 events4 affected239 at risk EG0012 events2 affected240 at risk
Oedema peripheral	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0012 events2 affected240 at risk
Pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0007 events4 affected239 at risk EG0010 events0 affected240 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 events3 affected239 at risk EG0011 events1 affected240 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0006 events6 affected239 at risk EG00112 events12 affected240 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 events3 affected239 at risk EG0013 events3 affected240 at risk
Influenza	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0005 events3 affected239 at risk EG0013 events3 affected240 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00031 events20 affected239 at risk EG00122 events21 affected240 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0007 events4 affected239 at risk EG0016 events6 affected240 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected239 at risk EG0014 events4 affected240 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0011 events1 affected240 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0014 events4 affected240 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected239 at risk EG0016 events6 affected240 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected239 at risk EG0013 events3 affected240 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0013 events2 affected240 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0010 events0 affected240 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0005 events5 affected239 at risk EG0011 events1 affected240 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 events3 affected239 at risk EG0013 events2 affected240 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0006 events4 affected239 at risk EG0011 events1 affected240 at risk
Insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected239 at risk EG0011 events1 affected240 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events4 affected239 at risk EG0013 events3 affected240 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 events3 affected239 at risk EG0011 events1 affected240 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 events3 affected239 at risk EG0018 events7 affected240 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0011 events1 affected240 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 events3 affected239 at risk EG0010 events0 affected240 at risk
Hypertension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0009 events9 affected239 at risk EG0014 events4 affected240 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
D049528	Insulin, Long-Acting

ID	Title	Description
BG000	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)
BG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
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	Insulin Lispro Mid Mixture	Insulin lispro mid mixture (MM) up to three times a day (TID)			11	239	91	239
EG001	Insulin Glargine	Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.			11	240	92	240