A Study for Type 2 Diabetic Patients | NCT00548808

ID	Type	Description	Link
F3Z-CR-IOPH	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Insulin lispro low mixture	Experimental	Insulin lispro low mixture (1, 2 or 3 daily injections)	Drug: Insulin lispro low mixture
Insulin glargine	Active Comparator	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)	Drug: Insulin glargine Drug: Insulin lispro

Name	Type	Description	Arm Group Labels	Other Names
Insulin lispro low mixture	Drug	Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.

Measure	Description	Time Frame
Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)		Baseline, 48 weeks

Measure	Description	Time Frame
Change in Hemoglobin A1c (HbA1c) Over Time		Baseline, 16 Weeks, 32 Weeks, 48 Weeks
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time		16 weeks, 32 weeks, 48 weeks

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.		Daw Park	South Australia	5041

PubMed Identifier	Type	Citation	Retractions
22672081	Derived	Bowering K, Reed VA, Felicio JS, Landry J, Ji L, Oliveira J. A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type 2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study. Diabet Med. 2012 Sep;29(9):e263-72. doi: 10.1111/j.1464-5491.2012.03722.x.

ID	Title	Description
FG000	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
FG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

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 to 48 Week Endpoint in Hemoglobin A1c (HbA1c)

Per-protocol set: randomized, no entry criteria violations, completed >=32 weeks of study, and no systemic glucocorticoid therapy for >14 cumulative days during study. Last observation carried forward.

Posted

Least Squares Mean

Standard Error

percent (%) glycated hemoglobin

Baseline, 48 weeks

ID	Title	Description
OG000	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
OG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Units	Counts
Participants	OG000177 OG001184

Title

Denominators

Categories

Title	Measurements
	OG000-1.91± 0.23 OG001-1.87± 0.23

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	ANCOVA Model: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use (Type III sums of squares).	0.716		Least Squares Mean Difference	-0.04	Standard Error of the Mean	0.11	2-Sided	95	-0.25	0.17			Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.	Yes	Non-Inferiority or Equivalence	A noninferiority margin of 0.4% for HbA1c was used.

Secondary

Change in Hemoglobin A1c (HbA1c) Over Time

Per-protocol set: randomized, no entry criteria violations, completed >=32 weeks of study, and no systemic glucocorticoid therapy for >14 cumulative days during study.

Posted

Least Squares Mean

Standard Error

percent (%) glycated hemoglobin

Baseline, 16 Weeks, 32 Weeks, 48 Weeks

ID	Title	Description
OG000	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
OG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time

Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.

Posted

Number

percentage of participants

16 weeks, 32 weeks, 48 weeks

ID	Title	Description
OG000	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
OG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Units	Counts
Participants	OG000

Secondary

7-point Self-monitored Blood Glucose Profiles

Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.

Posted

Mean

Standard Deviation

millimoles per liter (mmol/L)

Baseline, 16 weeks, 32 weeks, 48 weeks

ID	Title	Description
OG000	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
OG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Postprandial Blood Glucose Over Time

The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.

Per-protocol set: randomized; no entry criteria violations; completed >=32 weeks of study; no systemic glucocorticoid therapy >14 cumulative days during study.

Posted

Least Squares Mean

Standard Error

millimoles per liter

Baseline, 16 weeks, 32 weeks, 48 weeks

ID	Title	Description
OG000	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
OG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Units	Counts
Participants	OG000

Secondary

Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks

Full Analysis Set: all randomized patients who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Units of insulin per day (U/day)

16 weeks, 32 weeks, 48 weeks

ID	Title	Description
OG000	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
OG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Units	Counts
Participants	OG000

Secondary

Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks

Full Analysis Set: all randomized patients who received at least one dose of study drug.

Posted

Mean

Standard Deviation

Units of insulin/kilogram/day (U/kg/day)

16 weeks, 32 weeks, 48 weeks

ID	Title	Description
OG000	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
OG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Units	Counts
Participants	OG000

Secondary

Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles

Full Analysis Set: all randomized participants who received at least one dose of study drug and had baseline and endpoint values.

Posted

Least Squares Mean

Standard Error

millimoles/Liter (mmol/L)

baseline, 48 weeks

ID	Title	Description
OG000	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
OG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Units	Counts
Participants	OG000

Secondary

Safety: Number of Participants With Serious and Non-Serious Adverse Events

Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.

Full Analysis Set: all randomized participants who received at least one dose of study drug.

Posted

Number

participants

baseline through 48 weeks

ID	Title	Description
OG000	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
OG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute left ventricular failure	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Coronary artery disease	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0011 events1 affected212 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	One of these events resulted in death.	EG0002 events2 affected211 at risk EG0010 events0 affected212 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Enteritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Cardiac death	General disorders	MedDRA 12.0	Systematic Assessment	This event resulted in death.	EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Influenza like illness	General disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Abdominal abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Abscess limb	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0012 events2 affected212 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment		EG0002 events2 affected211 at risk EG0010 events0 affected212 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment		EG0002 events2 affected211 at risk EG0010 events0 affected212 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Brain stem infarction	Nervous system disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment		EG0000 events0 affected211 at risk EG0011 events1 affected212 at risk
Aortic stenosis	Vascular disorders	MedDRA 12.0	Systematic Assessment		EG0001 events1 affected211 at risk EG0010 events0 affected212 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Eosinophilia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected211 at risk EG0013 events3 affected212 at risk
Cataract	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0005 events4 affected211 at risk EG0011 events1 affected212 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0007 events5 affected211 at risk EG0017 events5 affected212 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0005 events4 affected211 at risk EG0012 events2 affected212 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0005 events4 affected211 at risk EG0010 events0 affected212 at risk
Toothache	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected211 at risk EG0012 events2 affected212 at risk
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected211 at risk EG0010 events0 affected212 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG00011 events10 affected211 at risk EG0011 events1 affected212 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected211 at risk EG0018 events8 affected212 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected211 at risk EG0012 events2 affected212 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected211 at risk EG0013 events3 affected212 at risk
Furuncle	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0013 events3 affected212 at risk
Influenza	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00024 events17 affected211 at risk EG00128 events22 affected212 at risk
Localised infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0014 events4 affected212 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected211 at risk EG0015 events4 affected212 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00015 events13 affected211 at risk EG00111 events9 affected212 at risk
Pharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0005 events4 affected211 at risk EG0012 events2 affected212 at risk
Respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected211 at risk EG0012 events2 affected212 at risk
Sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected211 at risk EG0013 events3 affected212 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0009 events6 affected211 at risk EG0019 events7 affected212 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00011 events10 affected211 at risk EG00110 events10 affected212 at risk
Viral infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0013 events3 affected212 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0008 events8 affected211 at risk EG0014 events4 affected212 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected211 at risk EG0014 events4 affected212 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected211 at risk EG0011 events1 affected212 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0004 events2 affected211 at risk EG0017 events5 affected212 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected211 at risk EG0015 events5 affected212 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0015 events4 affected212 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected211 at risk EG0010 events0 affected212 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0007 events6 affected211 at risk EG0018 events8 affected212 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected211 at risk EG0010 events0 affected212 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected211 at risk EG0014 events4 affected212 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00014 events8 affected211 at risk EG0014 events3 affected212 at risk
Sciatica	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected211 at risk EG0011 events1 affected212 at risk
Dysuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0013 events3 affected212 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected211 at risk EG0013 events3 affected212 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected211 at risk EG0018 events8 affected212 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0008 events8 affected211 at risk EG0019 events9 affected212 at risk
Venous insufficiency	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected211 at risk EG0013 events3 affected212 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	Insulin Lispro LM	Insulin lispro low mixture (1, 2 or 3 daily injections)
BG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
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 LM	Insulin lispro low mixture (1, 2 or 3 daily injections)			19	211	107	211
EG001	Insulin Glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)			13	212	116	212