Efficacy and Safety of Liraglutide Versus Placebo as add-... | NCT01620489

ID	Type	Description	Link
2011-002968-24	EudraCT Number
U1111-1122-3303	Other Identifier	WHO

Status Module

Label	Type	Description	Intervention Names
Lira 1.8 mg	Experimental		Drug: liraglutide
Placebo	Placebo Comparator		Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)	Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.	Week 0, Week 26

Secondary Outcomes

Measure	Description	Time Frame
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment	Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.	At week 26
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Or Monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines
HbA1c 7-10% (both inclusive)
Moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD (modification of diet in renal disease) formula at the screening visit
Body Mass Index (BMI) 20-45 kg/m^2 (both inclusive)

Exclusion Criteria:

Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator
Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal limit
History of chronic pancreatitis or idiopathic acute pancreatitis
Within the past 180 days any of the following: Episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ECG (electrocardiogram))
Heart failure defined as New York Heart Association (NYHA) class IV
A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure above or equal to 100 mmHg
Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator
Use of immunosuppressive treatment within 90 days prior to screening
Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Concord	California	94520	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
26681713	Result	Davies MJ, Bain SC, Atkin SL, Rossing P, Scott D, Shamkhalova MS, Bosch-Traberg H, Syren A, Umpierrez GE. Efficacy and Safety of Liraglutide Versus Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial. Diabetes Care. 2016 Feb;39(2):222-30. doi: 10.2337/dc14-2883. Epub 2015 Dec 17.
30663196

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lira 1.8 mg	Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Lira 1.8 mg	Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
BG001	Placebo	Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
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
	BG00068.0± 8.3 BG00166.3± 8.0 BG00267.2± 8.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00065 BG00172 BG002

Fasting plasma glucose (FPG)

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0009.48± 3.270 BG0019.27± 2.842 BG002

Glycosylated haemoglobin (%)(HbA1c)

Mean

Standard Deviation

Percent (%) glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.08± 0.792 BG0018.00± 0.853 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

Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)

Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.

The full analysis set (FAS) included all randomised subjects that received at least one dose of the study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.

Posted

Mean

Standard Deviation

percentage (%)

Week 0, Week 26

ID	Title	Description
OG000	Lira 1.8 mg	Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
OG001	Placebo	Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).

Units	Counts
Participants	OG000127 OG001136

Title

Denominators

Categories

Title	Measurements
	OG000-1.05± 0.8944 OG001-0.38± 0.8797

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	The null hypothesis of no treatment difference was tested using a two-sided test based on a mixed model repeated measurement (MMRM) analysis. The model included treatment, country, stratification groups (6 groups from cross-classifying renal function category (2 levels: eGFR<45 and ≥45 mL/min) and the background insulin treatment category (3 levels: basal, premix or no insulin)) as fixed effects factors and baseline HbA1c as a covariate, all nested within week.	Mixed Models Analysis		<0.0001	Adjustment for multiple comparisons was not used since there was only one primary endpoint.	Estimated treatment difference	-0.66				95	-0.90	-0.43

Secondary

Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment

Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.

The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.

Posted

Number

percentage of patients

At week 26

ID	Title	Description
OG000	Lira 1.8 mg	Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
OG001	Placebo	Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).

Secondary

Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment

Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.

The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.

Posted

Number

percentage of patients

At week 26

ID	Title	Description
OG000	Lira 1.8 mg	Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
OG001	Placebo	Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).

Secondary

Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles

SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model.

The FAS included all randomised subjects that received at least one dose of study medication. A total of 46 subjects in the FAS did not contribute to the analysis due to missing data.

Posted

Mean

Standard Deviation

mmol/L

Week 0, week 26

ID	Title	Description
OG000	Lira 1.8 mg	Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
OG001	Placebo	Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).

Secondary

Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)

Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.

The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.

Posted

Mean

Standard Deviation

kg/m^2

Week 0, week 26

ID	Title	Description
OG000	Lira 1.8 mg	Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
OG001	Placebo	Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).

Secondary

Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)

Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.

Safety analysis set included all subjects receiving at least one dose of the trial product. A total of 8 subjects in the safety analysis set did not contribute to the analysis due to missing data.

Posted

Geometric Mean

Geometric Coefficient of Variation

mL/min/1.73m˄2

Week 0, week 26

ID	Title	Description
OG000	Lira 1.8 mg	Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
OG001	Placebo	Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).

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	Lira 1.8 mg	Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).			14	140	73	140
EG001	Placebo	Subjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).			15	137	49	137

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Acute myocardial infarction	Cardiac disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0011 events1 affected137 at risk
Cardiac failure congestive	Cardiac disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Left ventricular failure	Cardiac disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Myocardial infarction	Cardiac disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Abdominal pain lower	Gastrointestinal disorders	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Chest pain	General disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Autoimmune hepatitis	Hepatobiliary disorders	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Cholecystitis	Hepatobiliary disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Arteriosclerotic gangrene	Infections and infestations	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Biliary sepsis	Infections and infestations	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Meningitis herpes	Infections and infestations	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Osteomyelitis	Infections and infestations	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Pneumonia	Infections and infestations	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Fall	Injury, poisoning and procedural complications	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Spinal cord injury lumbar	Injury, poisoning and procedural complications	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
C-reactive protein increased	Investigations	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Glomerular filtration rate decreased	Investigations	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Urine albumin/creatinine ratio increased	Investigations	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Diabetes mellitus	Metabolism and nutrition disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0011 events1 affected137 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Benign neoplasm of cervix uteri	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Cerebral haemorrhage	Nervous system disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Cerebrovascular accident	Nervous system disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Syncope	Nervous system disorders	Version 16.0	Systematic Assessment	EG0002 events2 affected140 at risk EG0010 events0 affected137 at risk
Renal impairment	Renal and urinary disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0011 events1 affected137 at risk
Urethral stenosis	Renal and urinary disorders	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Version 16.0	Systematic Assessment	EG0001 events1 affected140 at risk EG0010 events0 affected137 at risk
Colectomy	Surgical and medical procedures	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Arteriosclerosis	Vascular disorders	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk
Poor peripheral circulation	Vascular disorders	Version 16.0	Systematic Assessment	EG0000 events0 affected140 at risk EG0011 events1 affected137 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	Version 16.0	Systematic Assessment	EG0009 events8 affected140 at risk EG0012 events2 affected137 at risk
Diarrhoea	Gastrointestinal disorders	Version 16.0	Systematic Assessment	EG00013 events10 affected140 at risk EG0016 events4 affected137 at risk
Nausea	Gastrointestinal disorders	Version 16.0	Systematic Assessment	EG00039 events30 affected140 at risk EG00110 events6 affected137 at risk
Vomiting	Gastrointestinal disorders	Version 16.0	Systematic Assessment	EG00018 events17 affected140 at risk EG0014 events3 affected137 at risk
Nasopharyngitis	Infections and infestations	Version 16.0	Systematic Assessment	EG0007 events7 affected140 at risk EG00117 events16 affected137 at risk
Upper respiratory tract infection	Infections and infestations	Version 16.0	Systematic Assessment	EG0004 events4 affected140 at risk EG0018 events7 affected137 at risk
Glomerular filtration rate decreased	Investigations	Version 16.0	Systematic Assessment	EG00010 events9 affected140 at risk EG00114 events7 affected137 at risk
Lipase increased	Investigations	Version 16.0	Systematic Assessment	EG00023 events21 affected140 at risk EG00113 events12 affected137 at risk
Headache	Nervous system disorders	Version 16.0	Systematic Assessment	EG0008 events7 affected140 at risk EG0018 events4 affected137 at risk
Renal impairment	Renal and urinary disorders	Version 16.0	Systematic Assessment	EG0007 events7 affected140 at risk EG0018 events8 affected137 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

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

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists