Efficacy and Safety of Semaglutide Once-weekly Versus Pla... | NCT02054897

ID	Type	Description
2013-000632-94	EudraCT Number
U1111-1139-3090	Other Identifier	WHO
JapicCTI-142442	Registry Identifier	JAPIC

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Semaglutide 1.0 mg	Experimental	Drug: semaglutide
Semaglutide 0.5 mg	Experimental	Drug: semaglutide
Semaglutide placebo 1.0 mg	Placebo Comparator	Drug: placebo
Semaglutide placebo 0.5 mg	Placebo Comparator	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
semaglutide	Drug	Once weekly, administrated subcutaneously (s.c. under the skin)	Semaglutide 0.5 mg Semaglutide 1.0 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c (Glycosylated Haemoglobin)	Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.	Week 0, week 30

Secondary Outcomes

Measure	Description	Time Frame
Change in Body Weight	Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.	Week 0, week 30
Change in Fasting Plasma Glucose (FPG)

Eligibility 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		Anniston	Alabama	36207	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30047216	Background	Overgaard RV, Lindberg SO, Thielke D. Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach. Diabetes Obes Metab. 2019 Jan;21(1):43-51. doi: 10.1111/dom.13479. Epub 2018 Aug 23.
30938762	Background	Fonseca VA, Capehorn MS, Garg SK, Jodar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. J Clin Endocrinol Metab. 2019 Sep 1;104(9):4078-4086. doi: 10.1210/jc.2018-02685.

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Semaglutide 0.5 mg	Subjects were given 0.25 mg semaglutide once weekly subcutaneous (s.c.; under the skin) injections for 4 weeks followed by 0.5 mg semaglutide once weekly for the remaining 26 weeks of the treatment period.
FG001	Semaglutide 1.0 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Semaglutide 0.5 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
BG001	Semaglutide 1.0 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
BG002	Placebo	Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.
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
	ParticipantsBG000128 ParticipantsBG001130 ParticipantsBG002129 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000128 ParticipantsBG001130 ParticipantsBG002

Glycosylated haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of HbA1c

Title	Denominators	Categories
	ParticipantsBG000128 ParticipantsBG001130 ParticipantsBG002

Fasting plasma glucose

Number of subjects analysed=subjects with data available for fasting plasma glucose at baseline.

Mean

Standard Deviation

mmol/L

Title	Denominators	Categories
	ParticipantsBG000125 ParticipantsBG001129 ParticipantsBG002

Body weight

Mean

Standard Deviation

kilogram(s)

Title	Denominators	Categories
	ParticipantsBG000128 ParticipantsBG001130 ParticipantsBG002

Diastolic blood pressure

Mean

Standard Deviation

mmHg

Title	Denominators	Categories
	ParticipantsBG000128 ParticipantsBG001130 ParticipantsBG002

Systolic blood pressure

Mean

Standard Deviation

mmHg

Title	Denominators	Categories
	ParticipantsBG000128 ParticipantsBG001130 ParticipantsBG002

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 HbA1c (Glycosylated Haemoglobin)

Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Full analysis set

Posted

Mean

Standard Deviation

Percentage of HbA1c

Week 0, week 30

ID	Title	Description
OG000	Semaglutide 0.5 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
OG001	Semaglutide 1.0 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
OG002	Placebo	Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Units	Counts
Participants	OG000128 OG001130 OG002129

Title

Denominators

Categories

Title	Measurements
	OG000-1.47± 1.02 OG001-1.56± 1.26 OG002-0.00± 0.90

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001 OG002	For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 1.0 mg versus placebo. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.	Mixed Models Analysis		< 0.0001		Treatment difference	-1.53			2-Sided	95	-1.81	-1.25			Semaglutide 1.0 mg minus Placebo		Superiority	Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% confidence interval (CI) for the estimated difference was below 0%.

Secondary

Change in Body Weight

Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Full analysis set

Posted

Mean

Standard Deviation

kilogram(s)

Week 0, week 30

ID	Title	Description
OG000	Semaglutide 0.5 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
OG001	Semaglutide 1.0 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
OG002	Placebo	Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Secondary

Change in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Full analysis set. Number of subject analysed=subjects who contributed to the analysis.

Posted

Mean

Standard Deviation

mmol/L

Week 0, week 30

ID	Title	Description
OG000	Semaglutide 0.5 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
OG001	Semaglutide 1.0 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
OG002	Placebo	Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Secondary

Change in Systolic and Diastolic Blood Pressure

Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Full analysis set

Posted

Mean

Standard Deviation

mmHg

Week 0, week 30

ID	Title	Description
OG000	Semaglutide 0.5 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
OG001	Semaglutide 1.0 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
OG002	Placebo	Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Secondary

Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target

Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Full analysis set

Posted

Number

Percentage of subjects

At 30 weeks of treatment

ID	Title	Description
OG000	Semaglutide 0.5 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
OG001	Semaglutide 1.0 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
OG002	Placebo	Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Secondary

Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target

Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

Full analysis set

Posted

Number

Percentage of subjects

At 30 weeks of treatment

ID	Title	Description
OG000	Semaglutide 0.5 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.
OG001	Semaglutide 1.0 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.
OG002	Placebo	Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Semaglutide 0.5 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks followed by 0.5 mg semaglutide once weekly s.c. injections for the remaining 26 weeks of the treatment period.	7	128	53	128
EG001	Semaglutide 1.0 mg	Subjects were given 0.25 mg semaglutide once weekly s.c. injection for 4 weeks, 0.5 mg semaglutide once weekly s.c. injections for the next 4 weeks followed by 1.0 mg semaglutide once weekly s.c. injections for the remaining 22 weeks of the treatment period.	7	130	47	130
EG002	Placebo	Subjects were randomised to either of the 2 placebo arms (i.e., semaglutide placebo 0.5 mg and semaglutide placebo 1.0 mg) and then pooled for data analysis. Placebo 0.5 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks followed by 0.5 mg placebo once weekly s.c. injections for the remaining 26 weeks of the treatment period. Placebo 1.0 mg arm: Subjects were given 0.25 mg placebo once weekly s.c. injections for 4 weeks, 0.5 mg placebo once weekly s.c. injections for the next 4 weeks followed by 1.0 mg placebo once weekly s.c. injections for the remaining 22 weeks of the treatment period.	5	129	27	129

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected130 at risk EG0020 events0 affected129 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected130 at risk EG0021 events1 affected129 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected130 at risk EG0020 events0 affected129 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected130 at risk EG0020 events0 affected129 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected130 at risk EG0020 events0 affected129 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected130 at risk EG0020 events0 affected129 at risk
Cystitis	Infections and infestations	MedDRA 18	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected130 at risk EG0020 events0 affected129 at risk
Encephalitis	Infections and infestations	MedDRA 18	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected130 at risk EG0020 events0 affected129 at risk
Gastric bypass	Surgical and medical procedures	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0012 events2 affected130 at risk EG0020 events0 affected129 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected130 at risk EG0022 events1 affected129 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected130 at risk EG0020 events0 affected129 at risk
Inflammation	General disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected130 at risk EG0021 events1 affected129 at risk
Lobar pneumonia	Infections and infestations	MedDRA 18	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected130 at risk EG0020 events0 affected129 at risk
Mental disorder	Psychiatric disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected130 at risk EG0020 events0 affected129 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected130 at risk EG0021 events1 affected129 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected130 at risk EG0020 events0 affected129 at risk
Pericarditis	Cardiac disorders	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected130 at risk EG0020 events0 affected129 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected130 at risk EG0020 events0 affected129 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected130 at risk EG0020 events0 affected129 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected130 at risk EG0021 events1 affected129 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 18	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected130 at risk EG0020 events0 affected129 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 18	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected130 at risk EG0020 events0 affected129 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG0009 events8 affected128 at risk EG0015 events5 affected130 at risk EG0022 events1 affected129 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG00027 events16 affected128 at risk EG00119 events14 affected130 at risk EG0023 events3 affected129 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG00013 events7 affected128 at risk EG0015 events5 affected130 at risk EG0023 events3 affected129 at risk
Headache	Nervous system disorders	MedDRA 18	Systematic Assessment	EG00043 events15 affected128 at risk EG00118 events9 affected130 at risk EG00213 events8 affected129 at risk
Lipase increased	Investigations	MedDRA 18	Systematic Assessment	EG00010 events8 affected128 at risk EG0015 events5 affected130 at risk EG0025 events5 affected129 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18	Systematic Assessment	EG0007 events6 affected128 at risk EG0019 events6 affected130 at risk EG0029 events7 affected129 at risk
Nausea	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG00044 events26 affected128 at risk EG00146 events31 affected130 at risk EG00212 events10 affected129 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18	Systematic Assessment	EG00011 events5 affected128 at risk EG00115 events9 affected130 at risk EG0022 events2 affected129 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