52-week add-on to Metformin Comparison of Saxagliptin and... | NCT00575588

ID	Type	Description	Link
EudraCT number 2007-003998-55

Official Title

A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

Status Module

Name	Class
Bristol-Myers Squibb	INDUSTRY

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	Description	Intervention Names
Saxagliptin	Experimental		Drug: Metformin Drug: Saxagliptin
Glipizide	Experimental		Drug: Metformin Drug: Sulphonylurea

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	open-label metformin	Glipizide Saxagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52	Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.	Baseline to 52 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks	Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)	From Baseline to Week 52

Other Outcomes

Measure	Description	Time Frame
Hemoglobin A1c (HbA1c) Change From Baseline to Week 104	Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.	Baseline, Week 104

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Burkhard Goke	University of Munich, Germany	Principal Investigator
Peter Ohman, MD	AstraZeneca	Study Director
Deborah Price, MSc	AstraZeneca	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Hanko			Finland
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25414932	Derived	Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.
24397584	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
FG001	Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
BG001	Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0007.46± 0.045 OG0017.53± 0.045

Week 52

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Mean Difference (Net)	0.06	Standard Error of the Mean	0.053	2-Sided	95	-0.05	0.16				No	Superiority or Other

Secondary

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks

Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)

Posted

Number

Percentage of Participants

From Baseline to Week 52

ID	Title	Description
OG000	Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
OG001	Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin

Units	Counts
Participants	OG000

Secondary

Body Weight Change From Baseline to Week 52

Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.

Randomized participants who took at least 1 dose of double-blind treatment. To be included in the LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement

Posted

Mean

Standard Error

kilogram

Baseline, Week 52 (Last Observation Carried Forward)

ID	Title	Description
OG000	Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
OG001	Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin

Units	Counts
Participants

Secondary

Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c

Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.

Randomized participants who completed the 52 weeks of treatment had both baseline and week 52 HbA1c measurement and had no significant protocol deviations

Posted

Mean

Standard Error

Percent

Week 24 to Week 52

ID	Title	Description
OG000	Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
OG001	Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin

Units	Counts
Participants

Other Pre-specified

Hemoglobin A1c (HbA1c) Change From Baseline to Week 104

Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.

Number of subjects with observed values at Week 104 was n=184 for saxagliptin + metformin and n=160 for glipizide + metformin

Posted

Mean

Standard Error

Percent

Baseline, Week 104

ID	Title	Description
OG000	Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
OG001	Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin

Units	Counts
Participants	OG000

Other Pre-specified

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks

Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)

Posted

Number

Percentage of Participants

Baseline, Week 104

ID	Title	Description
OG000	Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
OG001	Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin

Units	Counts
Participants	OG000

Other Pre-specified

Body Weight Change From Baseline to Week 104

Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.

Number of subjects with observed values at Week 104 was n=186 for saxagliptin + metformin and n=165 for glipizide + metformin

Posted

Mean

Standard Error

kilograms

Baseline, Week 104

ID	Title	Description
OG000	Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
OG001	Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin

Units	Counts
Participants	OG000

Other Pre-specified

Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c

Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.

Posted

Mean

Standard Error

Percent

Week 24 to Week 104

ID	Title	Description
OG000	Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin
OG001	Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin

Units	Counts
Participants	OG000

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	Saxagliptin + Metformin	Saxagliptin 5 mg tablets added on to open-label metformin			54	428	105	428
EG001	Glipizide + Metformin	Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin			55	430	201	430

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial Fibrillation	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected428 at risk EG0012 affected430 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected428 at risk EG0011 affected430 at risk
Angina Pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Cardiac Failure	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0011 affected430 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0011 affected430 at risk
Myocardial Ischemia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Angina Unstable	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0012 affected430 at risk
Arteriosclerosis Coronary Artery	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Bradycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Coronary Artery Occlusion	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected428 at risk EG0011 affected430 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Jaw Cyst	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Anal Abscess	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 affected428 at risk EG0011 affected430 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Pyelonephritis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Helicobacter Gastritis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Superinfection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Meniscus Lesion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Open Wound	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0002 affected428 at risk EG0010 affected430 at risk
Metastasis To Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Salivary Gland Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0011 affected430 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Acute Abdomen	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Gastroesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0012 affected430 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Allergy To Arthropod Sting	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Hypersensitivity	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0011 affected430 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Laryngeal Edema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Deafness Bilateral	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Biliary Colic	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Cerebrovascular Disorder	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Cerebral Ischemia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0011 affected430 at risk
Ischemic Stroke	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Endometrial Hyperplasia	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0013 affected430 at risk
Hypotension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Arrhythmia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Herpes Zoster Ophthalmic	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Salmonella Sepsis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Urosepsis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Biliary Tract Infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected420 at risk
Acute Myeloid Leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Metastases to Central Nervous System	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Thyroid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Bladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Bronchial Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Colon Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Lip Neoplasm Malignant Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Lung Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Renal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Tumor Ulceration	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0011 affected430 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Patella Fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Epilepsy	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Hypertensive Encephalopathy	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Vertebrobasilar Insufficiency	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Transient Ischemic Attack	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Rectal Hemorrhage	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0011 affected430 at risk
Upper Gastrointestinal Hemorrhage	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Gastric Hemorrhage	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Cataract	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected428 at risk EG0010 affected430 at risk
Retinal Vein Occlusion	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Chest Pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0011 affected430 at risk
Device Malfunction	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0010 affected430 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Arteriosclerosis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0013 affected430 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Agitation	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Circulatory Collapse	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected428 at risk EG0011 affected430 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected428 at risk EG0011 affected430 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00025 affected428 at risk EG00117 affected430 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00046 affected428 at risk EG00141 affected430 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG00015 affected428 at risk EG001165 affected430 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00025 affected428 at risk EG00116 affected430 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG00019 affected428 at risk EG00127 affected430 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D014508	Urea
D000577	Amides
D013450	Sulfones
D013457	Sulfur Compounds

ID	Term
D008687	Metformin
D013453	Sulfonylurea Compounds
C502994	saxagliptin