Phase 3 28-Week Study With 24-Week and 52-week Extension... | NCT02229396

ID	Type	Description	Link
2014-003503-29	EudraCT Number

Official Title

A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin

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

Arm Groups

Label	Type	Intervention Names
Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg	Experimental	Drug: Exantide with Dapagliflozin
Exenatide Once Weekly 2 mg Alone	Experimental	Drug: Exentide
Dapagliflozin Once Daily 10 mg Alone	Active Comparator	Drug: Dapagliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exantide with Dapagliflozin	Drug	2 mg weekly suspension injection and 10 mg Dapagliflozin	Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c From Baseline to Week 28	To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.	Baseline to Week 28

Secondary Outcomes

Measure	Description	Time Frame
Change in Body Weight From Baseline to Week 28	To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.	Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 28

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35235	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32816874	Derived	Jabbour SA, Frias JP, Ahmed A, Hardy E, Choi J, Sjostrom CD, Guja C. Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial. Diabetes Care. 2020 Oct;43(10):2528-2536. doi: 10.2337/dc19-1350. Epub 2020 Aug 18.
32306296	Derived

Label	URL
CSP\_radacted	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Dapagliflozin + Placebo	Dapagliflozin 10 milligram (mg) tablet administered orally once daily + matching placebo for exenatide administered as subcutaneous (SC) injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
BG001	Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
BG002	Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
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
	BG00054.5± 9.16(28 to 75) BG00153.8± 9.82(26 to 80) BG00254.2± 9.62(29 to 80)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000120 BG001126 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

American Indian Or Alaska Native

Title	Measurements
	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in HbA1c From Baseline to Week 28

To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.

Posted

Least Squares Mean

95% Confidence Interval

% HbA1c

Baseline to Week 28

ID	Title	Description
OG000	Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG001	Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG002	Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Units	Counts
Participants	OG000230 OG001228 OG002227

Title

Denominators

Categories

Title	Measurements
	OG000-1.39(-1.57 to -1.21) OG001-1.98(-2.16 to -1.79) OG002-1.60(-1.79 to -1.41)

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		Mixed Models Analysis	Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.	0.003		Mean Difference (Final Values)	-0.38	Standard Error of the Mean	0.129	2-Sided	95	-0.63	-0.13					Superiority or Other
OG000 OG001

Secondary

Change in Body Weight From Baseline to Week 28

To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.

Posted

Least Squares Mean

95% Confidence Interval

kilogram

Baseline to Week 28

ID	Title	Description
OG000	Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG001	Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG002	Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Secondary

Change in Fasting Plasma Glucose From Baseline to Week 28

To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.

Posted

Least Squares Mean

95% Confidence Interval

milligrams/deciliter (mg/dL)

Baseline to Week 28

ID	Title	Description
OG000	Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG001	Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG002	Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Secondary

Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test

To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline to Week 28

ID	Title	Description
OG000	Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG001	Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG002	Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Secondary

Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28

To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.

Posted

Number

95% Confidence Interval

% of patients

Baseline to Week 28

ID	Title	Description
OG000	Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG001	Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG002	Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Secondary

Change in Fasting Plasma Glucose From Baseline to Week 2

To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline to Week 2

ID	Title	Description
OG000	Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG001	Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG002	Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Secondary

Percentage of Patients Achieving HbA1c <7% at Week 28

To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.

Posted

Number

95% Confidence Interval

% of patients

Baseline to Week 28

ID	Title	Description
OG000	Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG001	Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG002	Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Secondary

Change in Systolic Blood Pressure From Baseline to Week 28

To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.

Posted

Least Squares Mean

95% Confidence Interval

millimeters of mercury (mmHg)

Baseline to Week 28

ID	Title	Description
OG000	Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG001	Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.
OG002	Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dapagliflozin + Placebo	Dapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.	2	233	18	233	73	233
EG001	Exenatide + Dapagliflozin	Exenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.	3	231	17	231	87	231
EG002	Exenatide + Placebo	Exenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry.	1	230	18	230	78	230

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain lower	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 events2 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0022 events2 affected230 at risk
Bradycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0010 events0 affected231 at risk EG0022 events2 affected230 at risk
Palpitations	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Pituitary-dependent Cushing's syndrome	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Pancreatic necrosis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0012 events2 affected231 at risk EG0021 events1 affected230 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0010 events0 affected231 at risk EG0022 events1 affected230 at risk
Diverticulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Meningitis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Osteomyelitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0021 events1 affected230 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Hepatic enzyme increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0010 events0 affected231 at risk EG0022 events2 affected230 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Optic neuritis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Presyncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Anxiety	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0010 events0 affected231 at risk EG0021 events1 affected230 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected231 at risk EG0020 events0 affected230 at risk
Hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected231 at risk EG0020 events0 affected230 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00014 events11 affected233 at risk EG00117 events13 affected231 at risk EG00225 events17 affected230 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00012 events10 affected233 at risk EG00114 events13 affected231 at risk EG00229 events26 affected230 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0007 events7 affected233 at risk EG00110 events8 affected231 at risk EG00215 events12 affected230 at risk
Injection site nodule	General disorders	MedDRA 20.1	Systematic Assessment	EG00022 events13 affected233 at risk EG00140 events20 affected231 at risk EG00224 events14 affected230 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00015 events12 affected233 at risk EG00117 events15 affected231 at risk EG00210 events8 affected230 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00025 events22 affected233 at risk EG00122 events15 affected231 at risk EG00229 events17 affected230 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00023 events16 affected233 at risk EG00131 events19 affected231 at risk EG00224 events15 affected230 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG00012 events12 affected233 at risk EG00118 events16 affected231 at risk EG00212 events12 affected230 at risk

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