Comparison of the Effect of Exenatide Versus Sitagliptin... | NCT00729326

NCT00729326

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
Sequence A	Experimental		Drug: exenatide Drug: sitagliptin Drug: placebo
Sequence B	Experimental		Drug: exenatide Drug: sitagliptin Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
exenatide	Drug	subcutaneous injection (5mcg or 10mcg), twice a day	Sequence A Sequence B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Time-averaged Glucose During a 24 Hour Period	Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).	baseline and 8 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Two-hour Postprandial Glucose After the Morning Meal	Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)	baseline and 8 Weeks
Change in Fasting Blood Glucose After the Morning Meal

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have type 2 diabetes
Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.
Have a fasting glucose concentration <280 mg/dL at Visit 1
Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.
Are between 18 and 70 years of age, inclusive.
Have body mass index ≥25 kg/m2 and ≤45 kg/m2.
Have a history of stable body weight (not varying by >10% for at least 3 months prior to screening).
Can swallow oral study drug capsule, without splitting or crushing.

Exclusion Criteria:

Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:
- Are breastfeeding.
- Test positive for pregnancy at the time of screening.
- Intend to become pregnant during the study.
- Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.
Treated with any of the following medications:
- Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening
- Alpha-glucosidase inhibitor within 2 months of screening.
- Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
- Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1.
- Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.
Have a history of renal transplantation or are currently receiving renal dialysis.
Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.
Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.
Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Have had organ transplantation.
Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 3 months.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		San Antonio	Texas		United States

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	Exenatide Followed By Sitagliptin	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
FG001	Sitagliptin Followed By Exenatide

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	Exenatide Followed By Sitagliptin	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
BG001	Sitagliptin Followed By Exenatide	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00041 BG00142 BG00283

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
	BG00054.7± 10.10 BG00153.5± 9.49 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00019 BG00129 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 Time-averaged Glucose During a 24 Hour Period

Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).

The number of patients was determined based on 90% powering of the study. Analyses were based on data from all randomized patients receiving at least one dose of the study drug and completing at least one treatment period. For each patient, the missing data for some time points were imputed by linear interpolation.

Posted

Least Squares Mean

Standard Error

mg/dL

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG00067 OG00166

Title

Denominators

Categories

Title	Measurements
	OG000-41.65± 2.55 OG001-29.56± 2.58

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	Null hypothesis: The 24-hour average glucose for exenatide was greater than or equal to that for sitagliptin after 4 weeks of treatment. The primary objective was to compare exenatide with sitagliptin on the time-averaged glucose during the 24-hour inpatient periods after 4 weeks of treatment.	ANCOVA	Analyses for continuous variables adjusted for treatment, period, sequence, baseline of the continuous variable.Analysis method was Grizzle's model.	<.001	The p-values were not adjusted. The primary measure was change in 24-hour glucose without multiplicity adjustments for other analyses.						95						No

Secondary

Change in Two-hour Postprandial Glucose After the Morning Meal

Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)

All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

mg/dL

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Fasting Blood Glucose After the Morning Meal

Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)

All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

mg/dL

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal

Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)

All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

pmol*hours/L

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Postprandial Glucagon AUC Excursion After the Morning Meal

Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)

All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

pmol*hours/L

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Postprandial Triglyceride AUC After the Morning Meal

Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)

All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

mg*hours/dL

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Postprandial Triglyceride AUC Excursion After the Morning Meal

Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)

All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

mg*hours/dL

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Postprandial C-peptide AUC After the Morning Meal

Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)

All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

nmol*hours/L

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Postprandial C-peptide AUC Excursion After the Morning Meal

Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)

All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

nmol*hours/L

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Postprandial Insulin AUC After the Morning Meal

Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)

All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

pmol*hours/L

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Postprandial Insulin AUC Excursion After the Morning Meal

Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)

All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

pmol*hours/L

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Postprandial Active GLP-1 AUC After the Morning Meal

Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)

All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

pmol*hours/L

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal

Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)

All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward

Posted

Least Squares Mean

Standard Error

pmol*hours/L

baseline and 8 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)

Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL

All patients in FAS

Posted

Number

Percentage of patients

4 Weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Episodes of Hypoglycemia (Baseline to Week 4)

Number of episodes of hypoglycemia experienced during the first 4 weeks of the study

Full analysis set

Posted

Number

episodes of hypoglycemia

4 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)

Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL

All patients in FAS

Posted

Number

Percentage of patients

8 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Episodes of Hypoglycemia (Week 4 to Week 8)

Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study

All patients in FAS

Posted

Number

episodes of hypoglycemia

8 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Experiencing Hypoglycemia (Overall)

Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL

All patients in FAS

Posted

Number

Percentage of patients

4 weeks and 8 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.

Units	Counts
Participants	OG000

Secondary

Episodes of Hypoglycemia (Overall)

Number of episodes of hypoglycemia experienced overall during the study

All patients in FAS

Posted

Number

episodes of hypoglycemia

4 weeks and 8 weeks

ID	Title	Description
OG000	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
OG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 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	Exenatide	Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.			2	73	43	73
EG001	Sitagliptin	Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.			0	73	37	73

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaphylactic reaction	Immune system disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected73 at risk EG0010 affected73 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected73 at risk EG0010 affected73 at risk
Confusional state	Psychiatric disorders	MedDRA 12.0	Non-systematic Assessment	EG0001 affected73 at risk EG0010 affected73 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00027 affected73 at risk EG00112 affected73 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG00015 affected73 at risk EG0014 affected73 at risk
Headache	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0009 affected73 at risk EG0019 affected73 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0007 affected73 at risk EG0018 affected73 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Non-systematic Assessment	EG0007 affected73 at risk EG0015 affected73 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Non-systematic Assessment	EG0006 affected73 at risk EG0015 affected73 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0004 affected73 at risk EG0013 affected73 at risk
Asthenia	General disorders	MedDRA 12.0	Non-systematic Assessment	EG0004 affected73 at risk EG0011 affected73 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0004 affected73 at risk EG0015 affected73 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0004 affected73 at risk EG0011 affected73 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Non-systematic Assessment	EG0004 affected73 at risk EG0012 affected73 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0003 affected73 at risk EG0015 affected73 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Non-systematic Assessment	EG0002 affected73 at risk EG0015 affected73 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D000077270	Exenatide
D000068900	Sitagliptin Phosphate

Ancestor Terms

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014688	Venoms
D045424	Complex Mixtures
D014118	Toxins, Biological
D001685	Biological Factors
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines

Superiority or Other

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