Addition Of Exenatide To Insulin Glargine In Type 2 Diabe... | NCT00765817

NCT00765817

Status Module

Sponsor/Collaborators Module

Name	Class
Eli Lilly and Company	INDUSTRY

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

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

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Glycosylated Hemoglobin (HbA1c)	Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.	baseline and 30 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Patients Achieving HbA1c <=7%	Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).	baseline and 30 weeks
Percentage of Patients Achieving HbA1c <=6.5%

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have type 2 diabetes.
Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.

Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:

metformin (stable dose for 6 weeks)
pioglitazone (stable dose for 6 weeks)
a combination of metformin and pioglitazone (stable dose for 6 weeks)
- Have HbA1C between 7.1% and 10.5%, inclusive.
- Have a body mass index (BMI) ≤45 kg/m2.
- Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Exclusion Criteria:

Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
Women who are breastfeeding.
Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.
Have had a kidney transplant or are currently on kidney dialysis.
Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.
Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.
Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.
Are currently on a weight-loss program or have been on one within 3 months of entering the study.
Have had a blood transfusion or severe blood loss within 3 months of entering the study.
Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.
Have an irregular sleep cycle (for example, sleeping during the day and working during the night).
Have a history of pancreatitis.
Have received treatment with an experimental drug within 30 days of entering the study.
If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.
If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.

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

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Peoria	Arizona		United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24621255	Derived	Buse JB, Han J, Miller S, MacConell L, Pencek R, Wintle M. Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration. Curr Med Res Opin. 2014 Jul;30(7):1209-18. doi: 10.1185/03007995.2014.896329. Epub 2014 Mar 18.
23043166	Derived

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	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
FG001	Placebo Arm

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

Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

FG000138 subjectsOne subject withdrew prior to receiving study medication, not included in analysis set

FG001123 subjectsOne subject withdrew prior to receiving study medication, not included in analysis set

One subject per group withdrew from the study prior to the first dose of study medication and therefore are not part of the baseline or subsequent analysis.

Arm/Group Information

ID	Title	Description
BG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
BG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)
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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.67± 8.91 BG00159.40± 9.96 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00067 BG00144 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)

Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.

Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

percentage of hemoglobin

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000112 OG001100

Title

Denominators

Categories

Title	Measurements
	OG000-1.71± 0.09 OG001-1.00± 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		<0.001							95						No	Superiority or Other

Secondary

Percentage of Patients Achieving HbA1c <=7%

Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).

Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.

Posted

Number

percentage

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants

Secondary

Percentage of Patients Achieving HbA1c <=6.5%

Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).

Posted

Number

percentage

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants

Secondary

Change in Fasting Serum Glucose

Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

mmol/L

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

mmol/L

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants

Secondary

Change in Total Cholesterol

Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

mmol/L

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Change in Low Density Lipoprotein (LDL) Cholesterol

Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

mmol/L

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Change in High Density Lipoprotein (HDL) Cholesterol

Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.

Posted

Least Squares Mean

Standard Error

mmol/L

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Change in Triglycerides

Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)

Full analysis set. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

mmol/L

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Change in Body Weight

Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Change in Waist Circumference

Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Change in Daily Insulin Dose

Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

insulin units (U)

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Change in Daily Insulin Dose (on a Per Body Weight Basis)

Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

insulin units per kg (U/kg)

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Change in Systolic Blood Pressure (SBP)

Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

mmHg

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Change in Diastolic Blood Pressure (DBP)

Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)

Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis

Posted

Least Squares Mean

Standard Error

mmHg

baseline and 30 weeks

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants	OG000

Secondary

Minor Hypoglycemia Rate Per Year

Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).

Full analysis set

Posted

Mean

Standard Deviation

events per subject per year

baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants

Secondary

Percentage of Subjects Experiencing Minor Hypoglycemia

Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).

Full analysis set

Posted

Number

percentage

baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

ID	Title	Description
OG000	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)
OG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)

Units	Counts
Participants

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	Exenatide Arm	Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents)			8	137	109	138
EG001	Placebo Arm	Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents)			11	122	66	123

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chest pain	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected137 at risk EG0011 affected122 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected137 at risk EG0010 affected122 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0001 affected137 at risk EG0010 affected122 at risk
Angina unstable	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected137 at risk EG0010 affected122 at risk
Cystitis	Renal and urinary disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected137 at risk EG0010 affected122 at risk
Eye penetration	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0001 affected137 at risk EG0010 affected122 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Non-systematic Assessment	EG0001 affected137 at risk EG0010 affected122 at risk
Herpes zoster	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected137 at risk EG0010 affected122 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Palpitations	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Sepsis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Small intestine obstruction	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Staphylococcal infection	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0001 affected137 at risk EG0010 affected122 at risk
Suicide attempt	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Transient ischemic attack	Cardiac disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk
Uticaria	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0000 affected137 at risk EG0011 affected122 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00056 affected138 at risk EG00110 affected123 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00025 affected138 at risk EG00110 affected123 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00025 affected138 at risk EG0015 affected123 at risk
Headache	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG00019 affected138 at risk EG0015 affected123 at risk
Upper Respiratory Tract Infection	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00011 affected138 at risk EG0019 affected123 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00014 affected138 at risk EG0012 affected123 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0007 affected138 at risk EG0017 affected123 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Non-systematic Assessment	EG0008 affected138 at risk EG0016 affected123 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0006 affected138 at risk EG0017 affected123 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0009 affected138 at risk EG0012 affected123 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0009 affected138 at risk EG0012 affected123 at risk
Asthenia	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0007 affected138 at risk EG0011 affected123 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D000077270	Exenatide

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