The Efficacy and Safety of Liraglutide Adjunct to Insulin... | NCT02098395

ID	Type	Description
2012-005778-74	EudraCT Number
U1111-1138-0619	Other Identifier	WHO
NL47705.060.14	Registry Identifier	CCMO
REec-2014-0884	Registry Identifier	Spanish registry

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
Liraglutide 1.8 mg + insulin	Experimental	Drug: liraglutide
Liraglutide 1.2 mg + insulin	Experimental	Drug: liraglutide
Liraglutide 0.6 mg + insulin	Experimental	Drug: liraglutide
Liraglutide placebo 0.3 ml + insulin	Placebo Comparator	Drug: placebo
Liraglutide placebo 0.2 ml + insulin	Placebo Comparator	Drug: placebo
Liraglutide placebo 0.1 ml + insulin	Placebo Comparator	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glycosylated Haemoglobin (HbA1c)	Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.	Week 0, Week 26

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Body Weight	Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.	Week 0, Week 26
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

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		Phoenix	Arizona	85032	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27493132	Result	Ahren B, Hirsch IB, Pieber TR, Mathieu C, Gomez-Peralta F, Hansen TK, Philotheou A, Birch S, Christiansen E, Jensen TJ, Buse JB; ADJUNCT TWO Investigators. Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial. Diabetes Care. 2016 Oct;39(10):1693-701. doi: 10.2337/dc16-0690. Epub 2016 Aug 4.
27493232

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Liraglutide 0.6 mg	Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
FG001	Liraglutide 1.2 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Liraglutide 0.6 mg	Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
BG001	Liraglutide 1.2 mg	Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
BG002	Liraglutide 1.8 mg	Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
BG003	Liraglutide Placebo	Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.
BG004	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
	BG00043.9± 12.88 BG00142.8± 13.31 BG00243.2± 12.9 BG003

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000118 BG001106 BG002

Glycosylated Haemoglobin (HbA1c)

Mean

Standard Deviation

Percent (%) glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.09± 0.743 BG0018.07± 0.731 BG002

Body Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00083.10± 16.137 BG00184.69± 18.155 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 Glycosylated Haemoglobin (HbA1c)

Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.

Out of the 831 subjects in FAS, 22 subjects in lira 0.6 mg arm, 33 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 16 in placebo arm did not contribute to this analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.

Posted

Mean

Standard Deviation

Percent (%) glycosylated haemoglobin

Week 0, Week 26

ID	Title	Description
OG000	Liraglutide 0.6 mg	Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
OG001	Liraglutide 1.2 mg	Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
OG002	Liraglutide 1.8 mg	Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
OG003	Liraglutide Placebo	Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.

Units	Counts
Participants	OG000189 OG001176 OG002170 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.23± 0.744 OG001-0.23± 0.731 OG002-0.32± 0.73 OG003

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
OG002 OG003	Superiority of liraglutide 1.8 mg versus placebo was planned to be concluded if and only if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c was less than zero.	Mixed Models Analysis		< 0.0001		Mean Difference (Final Values)	-0.35			2-Sided	95	-0.5	-0.2				No	Superiority or Other
OG001 OG003

Secondary

Change From Baseline in Body Weight

Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.

Of the 831 subjects in FAS, 27 subjects in lira 0.6 mg arm, 38 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 26 in placebo arm did not contribute to the analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.

Posted

Mean

Standard Deviation

Week 0, Week 26

ID	Title	Description
OG000	Liraglutide 0.6 mg	Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
OG001	Liraglutide 1.2 mg	Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
OG002	Liraglutide 1.8 mg	Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

Secondary

Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes

Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.

Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo (SAS = 832 subjects). Symptomatic hypoglycaemic episodes were reported by 166 subjects in liraglutide 0.6 mg arm, 175 subjects in liraglutide 1.2 mg, 160 subjects in liraglutide 1.8 mg arm and 162 subjects in liraglutide placebo arm.

Posted

Number

episodes

Weeks 0-26

ID	Title	Description
OG000	Liraglutide 0.6 mg	Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
OG001	Liraglutide 1.2 mg	Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Liraglutide 0.6 mg	Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.	20	211	137	211
EG001	Liraglutide 1.2 mg	Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.	21	209	164	209
EG002	Liraglutide 1.8 mg	Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.	14	206	162	206
EG003	Liraglutide Placebo	Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.	14	206	125	206

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG0030 events0 affected206 at risk
Angina unstable	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Goitre	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0012 events2 affected209 at risk EG0020 events0 affected206 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0021 events1 affected206 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0012 events2 affected209 at risk EG0020 events0 affected206 at risk EG003
Chest discomfort	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0021 events1 affected206 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0021 events1 affected206 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Intervertebral disc injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0022 events2 affected206 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0006 events5 affected211 at risk EG0012 events2 affected209 at risk EG0021 events1 affected206 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0021 events1 affected206 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Hypoglycaemic coma	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0005 events3 affected211 at risk EG0017 events6 affected209 at risk EG0022 events2 affected206 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0021 events1 affected206 at risk EG003
VIth nerve paralysis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0021 events1 affected206 at risk EG003
Anxiety disorder	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0021 events1 affected206 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0021 events1 affected206 at risk EG003
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Diabetic nephropathy	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0021 events1 affected206 at risk EG003
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0010 events0 affected209 at risk EG0021 events1 affected206 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003
Wrist surgery	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected211 at risk EG0011 events1 affected209 at risk EG0020 events0 affected206 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected211 at risk EG0010 events0 affected209 at risk EG0020 events0 affected206 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 events3 affected211 at risk EG00118 events14 affected209 at risk EG0027 events7 affected206 at risk EG0037 events6 affected206 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0008 events8 affected211 at risk EG00113 events8 affected209 at risk EG00217 events14 affected206 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0006 events6 affected211 at risk EG00129 events23 affected209 at risk EG00215 events14 affected206 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00017 events14 affected211 at risk EG00130 events25 affected209 at risk EG00243 events30 affected206 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 events8 affected211 at risk EG00123 events19 affected209 at risk EG00235 events24 affected206 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00081 events68 affected211 at risk EG001122 events97 affected209 at risk EG002170 events102 affected206 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00025 events19 affected211 at risk EG00140 events29 affected209 at risk EG00265 events35 affected206 at risk EG003
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG00013 events13 affected211 at risk EG00118 events17 affected209 at risk EG00225 events22 affected206 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0007 events6 affected211 at risk EG00111 events11 affected209 at risk EG0029 events8 affected206 at risk EG003
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00015 events15 affected211 at risk EG00123 events18 affected209 at risk EG00219 events18 affected206 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00059 events44 affected211 at risk EG00152 events40 affected209 at risk EG00267 events47 affected206 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0007 events7 affected211 at risk EG00112 events11 affected209 at risk EG0023 events3 affected206 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00020 events14 affected211 at risk EG00113 events11 affected209 at risk EG00214 events11 affected206 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00021 events21 affected211 at risk EG00142 events40 affected209 at risk EG00255 events50 affected206 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00014 events10 affected211 at risk EG00117 events13 affected209 at risk EG00216 events12 affected206 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0004 events3 affected211 at risk EG0016 events5 affected209 at risk EG00210 events8 affected206 at risk EG003
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00027 events16 affected211 at risk EG00133 events26 affected209 at risk EG00243 events30 affected206 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00012 events10 affected211 at risk EG0014 events4 affected209 at risk EG00219 events14 affected206 at risk EG003

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune 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