Comparison of Two Basal Insulins for Patients With Type 2... | NCT00560417

NCT00560417

ID	Type	Description	Link
F3Z-US-IOPB	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ILPS	Active Comparator	Insulin Lispro Protamine Suspension (ILPS)	Drug: Insulin Lispro Protamine Suspension
Glargine	Active Comparator	Insulin Glargine	Drug: Insulin Glargine

Name	Type	Description	Arm Group Labels	Other Names
Insulin Lispro Protamine Suspension	Drug	Administered subcutaneously once a day at bedtime	ILPS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.	Baseline, Endpoint (LOCF) up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.	24 weeks, Endpoint (LOCF) up to 24 weeks
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Eligibility Module

Contacts/Locations 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

Locations

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.		Phoenix	Arizona	85028

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
FG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
BG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
BG002	Total	Total of all reporting groups

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
	BG00056.51± 9.73 BG00156.24± 9.33 BG00256.38± 9.52

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00095 BG00175 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Black or African American

Title	Measurements
	BG00013 BG00114 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000165 BG001165 BG002

Body Mass Index

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

Mean

Standard Deviation

kilograms/square meters (kg/m^2)

Title

Denominators

Categories

Title	Measurements
	BG00034.92± 5.21 BG00134.78± 5.17

Body Weight

Mean

Standard Deviation

Kilograms

Title

Denominators

Categories

Title	Measurements
	BG000101.57± 18.67 BG001102.33± 19.73 BG002

Hemoglobin A1C

Mean

Standard Deviation

percent of glycosylated hemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.21± 0.79 BG0018.22± 0.80 BG002

Sulfonylurea Group

Participants taking a sulfonylurea at baseline.

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG000108 BG001110 BG002

Duration of Diabetes

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0009.51± 5.98 BG00110.31± 6.63 BG002

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 Endpoint (Last Observation Carried Forward [LOCF])

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Least Squares Mean

Standard Error

percent of glycosylated hemoglobin

Baseline, Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts
Participants	OG000170 OG001167

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0008.48± 0.04 OG0018.47± 0.04

Endpoint (LOCF) Change

Title	Measurements
	OG000

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	Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group.			Mean Difference (Final Values)	0.22			2-Sided	95	0.06	0.38				Yes	Non-Inferiority or Equivalence	Noninferiority margin was prespecified at 0.4%

Secondary

Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Least Squares Mean

Standard Error

percent of glycosylated hemoglobin

24 weeks, Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Least Squares Mean

Standard Error

percent of glycosylated hemoglobin

Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Number

percent of participants

Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts
Participants	OG000

Secondary

7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Mean

Standard Deviation

milligrams per deciliter (mg/dL)

Baseline, Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts
Participants	OG000

Secondary

Glycemic Variability at Baseline and Endpoint (LOCF)

Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts
Participants	OG000

Secondary

Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Number

percentage of participants

Baseline to Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts

Secondary

Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Mean

Standard Deviation

episodes/participant/365 days

Baseline to Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts

Secondary

Actual Body Weight at Baseline and Endpoint (LOCF)

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Mean

Standard Deviation

kilograms

Baseline, Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Weight at Endpoint (LOCF)

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Mean

Standard Deviation

kilograms

Baseline, Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts
Participants	OG000

Secondary

Total Daily Insulin Dose at Endpoint (LOCF)

All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Posted

Mean

Standard Deviation

Units of Insulin

Endpoint (LOCF) up to 24 weeks

ID	Title	Description
OG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
OG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ILPS	Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks			9	170	96	170
EG001	Glargine	Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks			5	167	115	167

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected170 at risk EG0010 events0 affected167 at risk
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected167 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0012 events1 affected167 at risk
Appendicitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected167 at risk
Cystitis bacterial	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0010 events0 affected167 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected170 at risk EG0010 events0 affected167 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0013 events1 affected167 at risk
Drug exposure during pregnancy	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected167 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0011 events1 affected167 at risk
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0013 events1 affected167 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected167 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected167 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected167 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0010 events0 affected167 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0009 events6 affected170 at risk EG0015 events4 affected167 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00017 events11 affected170 at risk EG00131 events12 affected167 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected170 at risk EG00114 events4 affected167 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00037 events13 affected170 at risk EG00114 events10 affected167 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0007 events6 affected170 at risk EG00111 events8 affected167 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected170 at risk EG0015 events5 affected167 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 events1 affected170 at risk EG0019 events5 affected167 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected170 at risk EG00115 events12 affected167 at risk
Influenza	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0008 events4 affected170 at risk EG0014 events3 affected167 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00018 events12 affected170 at risk EG00114 events9 affected167 at risk
Sinusitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00017 events7 affected170 at risk EG00126 events9 affected167 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG00023 events11 affected170 at risk EG00124 events10 affected167 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0009 events5 affected170 at risk EG0013 events2 affected167 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG00027 events4 affected170 at risk EG00110 events2 affected167 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG00019 events9 affected170 at risk EG00135 events7 affected167 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0008 events3 affected170 at risk EG0019 events4 affected167 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0007 events2 affected170 at risk EG00128 events4 affected167 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected170 at risk EG0015 events4 affected167 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0005 events3 affected170 at risk EG00117 events5 affected167 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00044 events11 affected170 at risk EG00142 events15 affected167 at risk
Sinus headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected170 at risk EG0012 events1 affected167 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG00013 events5 affected170 at risk EG00113 events5 affected167 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0005 events3 affected170 at risk EG00118 events9 affected167 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0009 events4 affected170 at risk EG00111 events7 affected167 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG00013 events6 affected170 at risk EG0018 events2 affected167 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
D000069036	Insulin Glargine

Ancestor Terms

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

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