Effect of Liraglutide on Body Weight in Overweight or Obe... | NCT01272232

ID	Type	Description	Link
2008-002199-88	EudraCT Number
U1111-1118-7963	Other Identifier	WHO

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Intervention Names
Lira 3.0 mg	Experimental	Drug: liraglutide
Lira 1.8 mg	Experimental	Drug: liraglutide
Placebo	Experimental	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.	Lira 3.0 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change (%) From Baseline in Body Weight (Fasting)	Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.	Week 0, week 56
Proportion of Subjects Losing at Least 5% of Baseline Body Weight	Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.	at 56 weeks
Proportion of Subjects Losing More Than 10% of Baseline Body Weight	Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.	at 56 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)	Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.	Week 0, week 56
Proportion of Subjects Reaching Target HbA1c Below 7%

Eligibility Module

Contacts/Locations Module

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		Vestavia Hills	Alabama	35209	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29145215	Background	le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m(2): A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17.
27193270	Result	Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422. doi: 10.1007/s40262-016-0410-7.

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
BG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
BG002	Liraglutide Placebo	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
BG003	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
	BG00055.0± 10.8 BG00154.9± 10.7 BG00254.7± 9.8 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000203 BG001103 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00046 BG00117 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0004 BG0010 BG002

Age group

Number

participants

Title

Denominators

Categories

18- < 40 years

Title	Measurements
	BG00038 BG00115 BG002

Fasting body weight

Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000105.7± 21.9 BG001

Height

Height was recorded without shoes.

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG0001.69± 0.11 BG0011.69± 0.10 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00037.1± 6.5 BG00137.0± 6.9 BG002

Body Mass Index (BMI) group

Number

participants

Title

Denominators

Categories

25.0-29.9 kg/m^2 - pre-obese

Title	Measurements
	BG00052 BG00134 BG002

HbA1c (glycosylated haemoglobin)

Mean

Standard Deviation

Percent (%) glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0007.9± 0.8 BG0018.0± 0.8 BG002

Fasting plasma glucose

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0008.8± 1.9 BG0018.9± 2.0 BG002

Co-morbid hypertension

Presence or absence of untreated or treated hypertension

Number

participants

Title

Denominators

Categories

Present

Title	Measurements
	BG000293 BG001148 BG002

Co-morbid dyslipidaemia

Presence or absence of untreated or treated dyslipidaemia

Number

participants

Title

Denominators

Categories

Present

Title	Measurements
	BG000295 BG001143 BG002

Duration of diabetes

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0007.54± 5.65 BG0017.43± 5.16 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change (%) From Baseline in Body Weight (Fasting)

Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.

Posted

Mean

Standard Deviation

percent change

Week 0, week 56

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG002	Liraglutide Placebo	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Units	Counts
Participants	OG000412 OG001204 OG002211

Title

Denominators

Categories

Title	Measurements
	OG000-5.9± 5.5 OG001-4.6± 5.5 OG002-2.0± 4.3

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 OG002	The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.	ANCOVA		<0.0001	Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.	Treatment contrast	-3.97				95	-4.84	-3.11					Superiority or Other

Primary

Proportion of Subjects Losing at Least 5% of Baseline Body Weight

Posted

Number

percentage of subjects

at 56 weeks

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Primary

Proportion of Subjects Losing More Than 10% of Baseline Body Weight

Posted

Number

percentage of subjects

at 56 weeks

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Secondary

Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)

Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.

Posted

Mean

Standard Deviation

percentage point change of HbA1c

Week 0, week 56

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Secondary

Proportion of Subjects Reaching Target HbA1c Below 7%

Posted

Number

percentage of subjects

at 56 weeks

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Secondary

Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%

Posted

Number

percentage of subjects

at 56 weeks

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Secondary

Change From Baseline in Waist Circumference

Posted

Mean

Standard Deviation

Week 0, week 56

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Secondary

Change (%) From Baseline in Body Weight (Fasting)

Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.

Posted

Mean

Standard Deviation

percent change

Week 0, week 68

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Secondary

Change (%) From Week 56 to 68 in Body Weight (Fasting)

Posted

Mean

Standard Deviation

percent change

Week 56, week 68

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Secondary

Change From Baseline in Waist Circumference

Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.

Posted

Mean

Standard Deviation

Week 0, week 68

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Secondary

Change From Week 56 to 68 in Waist Circumference

Posted

Mean

Standard Deviation

Week 56, week 68

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Secondary

Incidence of Hypoglycaemic Episodes

Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL]).

Safety analysis set, comprising all randomised subjects who had been exposed to at least one dose of trial product.

Posted

Number

Episodes/100 years of patient exposure

Weeks 0-56

ID	Title	Description
OG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
OG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Liraglutide 3.0 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.	37	422	361	422
EG001	Liraglutide 1.8 mg	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.	18	210	173	210
EG002	Liraglutide Placebo	Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.	13	212	164	212

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Angina unstable	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Coronary artery disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0012 events2 affected210 at risk EG0021 events1 affected212 at risk
Meniere	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Ulcerative keratitis	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Chest discomfort	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Appendicitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Arthritis infective	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Bronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Erysipelas	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Lobar pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Blood calcitonin increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Catheterisation cardiac	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Pancreatic enzymes increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0012 events2 affected210 at risk EG0020 events0 affected212 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0021 events1 affected212 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Syncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Panic attack	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Urinary retention	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0021 events1 affected212 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Angioplasty	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0010 events0 affected210 at risk EG0021 events1 affected212 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected422 at risk EG0010 events0 affected210 at risk EG0022 events1 affected212 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Nasal operation	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected422 at risk EG0011 events1 affected210 at risk EG0020 events0 affected212 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected422 at risk EG0010 events0 affected210 at risk EG0020 events0 affected212 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00032 events26 affected422 at risk EG00111 events10 affected210 at risk EG0023 events3 affected212 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00034 events26 affected422 at risk EG0014 events4 affected210 at risk EG0029 events9 affected212 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00021 events15 affected422 at risk EG00117 events14 affected210 at risk EG0022 events2 affected212 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00078 events68 affected422 at risk EG00124 events20 affected210 at risk EG00214 events13 affected212 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG000173 events108 affected422 at risk EG00150 events37 affected210 at risk EG00235 events27 affected212 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00059 events47 affected422 at risk EG00116 events14 affected210 at risk EG0025 events5 affected212 at risk
Flatulence	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00026 events22 affected422 at risk EG0018 events8 affected210 at risk EG0024 events4 affected212 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG000208 events138 affected422 at risk EG00184 events66 affected210 at risk EG00234 events29 affected212 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG000113 events66 affected422 at risk EG00127 events21 affected210 at risk EG00214 events12 affected212 at risk
Fatigue	General disorders	MedDRA 15.1	Systematic Assessment	EG00045 events35 affected422 at risk EG00111 events11 affected210 at risk EG0027 events7 affected212 at risk
Injection site haematoma	General disorders	MedDRA 15.1	Systematic Assessment	EG00033 events19 affected422 at risk EG0014 events4 affected210 at risk EG00214 events12 affected212 at risk
Bronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00014 events13 affected422 at risk EG00116 events12 affected210 at risk EG00215 events11 affected212 at risk
Influenza	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00024 events22 affected422 at risk EG00114 events12 affected210 at risk EG00216 events15 affected212 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG000134 events88 affected422 at risk EG00146 events34 affected210 at risk EG00254 events41 affected212 at risk
Sinusitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00019 events16 affected422 at risk EG00118 events15 affected210 at risk EG00222 events18 affected212 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00049 events40 affected422 at risk EG00125 events23 affected210 at risk EG00219 events18 affected212 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00034 events19 affected422 at risk EG00117 events13 affected210 at risk EG00214 events12 affected212 at risk
Lipase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG00056 events50 affected422 at risk EG00126 events22 affected210 at risk EG00216 events14 affected212 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00044 events40 affected422 at risk EG00123 events23 affected210 at risk EG0024 events4 affected212 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG000981 events187 affected422 at risk EG001429 events84 affected210 at risk EG002154 events59 affected212 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00042 events30 affected422 at risk EG00125 events17 affected210 at risk EG00215 events12 affected212 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00067 events42 affected422 at risk EG00136 events27 affected210 at risk EG00227 events20 affected212 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00024 events22 affected422 at risk EG00110 events9 affected210 at risk EG0027 events6 affected212 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00020 events16 affected422 at risk EG00113 events12 affected210 at risk EG00212 events10 affected212 at risk
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00039 events30 affected422 at risk EG00115 events10 affected210 at risk EG0027 events6 affected212 at risk
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG000125 events66 affected422 at risk EG00142 events26 affected210 at risk EG00240 events29 affected212 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00021 events18 affected422 at risk EG00116 events12 affected210 at risk EG0029 events8 affected212 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00012 events12 affected422 at risk EG0018 events7 affected210 at risk EG00212 events11 affected212 at risk

ID	Term
D009748	Nutrition Disorders
D009765	Obesity

ID	Term
D009750	Nutritional and Metabolic Diseases
D050177	Overweight
D044343	Overnutrition
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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