Efficacy and Safety of Exenatide in Japanese Patients Wit... | NCT00577824

Status Module

Name	Class
Eli Lilly and Company	INDUSTRY

Oversight Module

Label	Type	Intervention Names
1	Experimental	Drug: exenatide
2	Experimental	Drug: exenatide
3	Placebo Comparator	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
exenatide	Drug	subcutaneous injection, 5mcg, twice a day	1	LY2148568

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24	Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)	baseline, 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Patients Achieving HbA1c < 7.0%	Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)	24 weeks
Percentage of Patients Achieving HbA1c < 6.5%

Eligibility Module

Name	Affiliation	Role
Chief Medical Officer, MD	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Chiba			Japan
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24843486	Result	Kadowaki T, Namba M, Imaoka T, Yamamura A, Goto W, Boardman MK, Sowa H. Improved glycemic control and reduced bodyweight with exenatide: A double-blind, randomized, phase 3 study in Japanese patients with suboptimally controlled type 2 diabetes over 24 weeks. J Diabetes Investig. 2011 Jun 5;2(3):210-7. doi: 10.1111/j.2040-1124.2010.00084.x.
24843529

Results Section

Participant Flow Module

ID	Title	Description
FG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
FG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.5± 9.33 BG00159.4± 9.75 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00023 BG00123 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 in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24

Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

Full analysis set; Last observation carried forward.

Posted

Least Squares Mean

Standard Error

Percentage of hemoglobin

baseline, 24 weeks

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG00071 OG00172 OG00235

Title

Denominators

Categories

Title	Measurements
	OG000-1.34± 0.11 OG001-1.62± 0.11 OG002-0.28± 0.15

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
OG001 OG002		ANCOVA	ANCOVA model with treatment group as a factor and baseline value as the covariate.	<0.001	Bonferroni's method was used to adjustment for multiplicity, and significant level was set to 2.5%(two-sided).						95						No	Superiority or Other

Secondary

Percentage of Patients Achieving HbA1c < 7.0%

Percentage of subjects whose HbA1c was >=7.0% at baseline who achieved an HbA1c < 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 7.0% divided by total number of eligible subjects times 100)

Full analysis set; Last observation carried forward. Only those patients with HbA1c >=7% at baseline included.

Posted

Number

percentage of participants

24 weeks

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Achieving HbA1c < 6.5%

Percentage of subjects whose HbA1c was >=6.5% at baseline who achieved an HbA1c < 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c < 6.5% divided by total number of eligible subjects times 100)

Full analysis set; Last observation carried forward. Only subjects whose HbA1c was >=6.5% at baseline were included.

Posted

Number

percentage of participants

24 weeks

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in Fasting Blood Glucose

Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)

Full analysis set; Last observation carried forward

Posted

Least Squares Mean

Standard Error

mg/dL

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in Body Weight

Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)

Full analysis set; Last observation carried forward

Posted

Least Squares Mean

Standard Error

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in Total Cholesterol

Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)

Full analysis set; Last observation carried forward

Posted

Mean

Standard Error

mg/dL

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in Low Density Lipoprotein Cholesterol (LDL-C)

Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)

Full analysis set; Last observation carried forward.

Posted

Mean

Standard Error

mg/dL

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in High Density Lipoprotein Cholesterol (HDL-C)

Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)

Full analysis set; Last observation carried forward.

Posted

Mean

Standard Error

mg/dL

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in Triglycerides

Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)

Full analysis set; Last observation carried forward

Posted

Mean

Standard Error

mg/dL

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in Waist Size

Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)

Full Analysis Set; Last Observation Carried Forward

Posted

Mean

Standard Error

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in Waist-to-hip Ratio

Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.

Full Analysis Set; Last Observation Carried Forward

Posted

Mean

Standard Error

ratio (cm/cm)

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24

Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).

Full Analysis Set; Last Observation Carried Forward

Posted

Mean

Standard Deviation

mg/dL

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)

Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.

Full Analysis Set; Last Observation Carried Forward

Posted

Mean

Standard Error

ratio

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)

Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.

Full Analysis Set; Last Observation Carried Forward

Posted

Mean

Standard Error

ratio

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in Serum Insulin

Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)

Full Analysis Set; Last Observation Carried Forward

Posted

Mean

Standard Deviation

mcU/mL

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in C-peptide

Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)

Full Analysis Set; Last Observation Carried Forward

Posted

Mean

Standard Error

ng/mL

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Secondary

Change in 1,5-anhydroglucitol

Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)

Full Analysis Set; Last Observation Carried Forward

Posted

Mean

Standard Error

mcg/mL

baseline, week 24

ID	Title	Description
OG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
OG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
OG002	Placebo BID	placebo SC, twice daily

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected72 at risk EG0021 affected35 at risk
Gastric mucosal lesion	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected72 at risk EG0021 affected35 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected72 at risk EG0021 affected35 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected72 at risk EG0021 affected35 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected72 at risk EG0010 affected72 at risk EG0020 affected35 at risk
Major depression	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected72 at risk EG0010 affected72 at risk EG0020 affected35 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected72 at risk EG0010 affected72 at risk EG0020 affected35 at risk
Sleep apnea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected72 at risk EG0021 affected35 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00037 affected72 at risk EG00142 affected72 at risk EG0028 affected35 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected72 at risk EG00126 affected72 at risk EG0023 affected35 at risk
Blood glucose decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG00010 affected72 at risk EG00118 affected72 at risk EG0024 affected35 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected72 at risk EG00112 affected72 at risk EG0021 affected35 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected72 at risk EG00111 affected72 at risk EG0021 affected35 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0008 affected72 at risk EG0019 affected72 at risk EG0028 affected35 at risk
Stomach discomfort	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected72 at risk EG0019 affected72 at risk EG0021 affected35 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected72 at risk EG0019 affected72 at risk EG0021 affected35 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected72 at risk EG0018 affected72 at risk EG0021 affected35 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected72 at risk EG0015 affected72 at risk EG0020 affected35 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected72 at risk EG0014 affected72 at risk EG0022 affected35 at risk
Feeling abnormal	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected72 at risk EG0014 affected72 at risk EG0020 affected35 at risk
Malaise	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected72 at risk EG0014 affected72 at risk EG0022 affected35 at risk
Blood creatinine phosphokinase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected72 at risk EG0013 affected72 at risk EG0022 affected35 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected72 at risk EG0012 affected72 at risk EG0022 affected35 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected72 at risk EG0012 affected72 at risk EG0022 affected35 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected72 at risk EG0012 affected72 at risk EG0020 affected35 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected72 at risk EG0012 affected72 at risk EG0021 affected35 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
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014688	Venoms
D045424	Complex Mixtures
D014118	Toxins, Biological
D001685	Biological Factors

ID	Title	Description
BG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily
BG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily
BG002	Placebo BID	placebo SC, twice daily
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	5mcg Exenatide BID	exenatide SC 5mcg, twice daily	2	72	63	72
EG001	10mcg Exenatide BID	exenatide SC 10mcg, twice daily	0	72	63	72
EG002	Placebo BID	placebo SC, twice daily	4	35	22	35