Efficacy and Safety of MP-513 in Combination With Metform... | NCT00971243

NCT00971243

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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
MP-513 Lowest Dose and Metformin	Experimental	Drug: MP-513 Lowest Dose and Metformin
MP-513 Low Dose and Metformin	Experimental	Drug: MP-513 Low Dose and Metformin
MP-513 Medium Dose and Metformin	Experimental	Drug: MP-513 Medium Dose and Metformin
MP-513 High Dose and Metformin	Experimental	Drug: MP-513 High Dose and Metformin
Placebo and Metformin	Placebo Comparator	Drug: Placebo and Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MP-513 Lowest Dose and Metformin	Drug	MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.	MP-513 Lowest Dose and Metformin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c From Baseline to Week 24	The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.	Baseline and Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24	Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.	Baseline and Week 24
Adverse Events, Laboratory Tests, Vital Signs, Etc.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
David Kerr, Dr	Royal Bournemouth Hospital	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24205974	Derived	Kadowaki T, Kondo K. Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014 May;16(5):418-25. doi: 10.1111/dom.12235. Epub 2013 Dec 10.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Teneli 5mg+Met	Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
FG001	Teneli 10mg+Met

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin

FG00388 subjectsOne subject who did not receive any study drug was excluded from the ITT

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Teneli 5mg+Met	Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
BG001	Teneli 10mg+Met	Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
BG002	Teneli 20mg+Met	Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
BG003	Teneli 40mg+Met	Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
BG004	Placebo+Met	Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
BG005	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
	OG000-0.58± 0.07 OG001-0.68± 0.07 OG002-0.76± 0.07 OG003

Secondary

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24

Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.

LOCF was implemented in the ITT population analysis to replace missing values for all those subjects who did not present a FPG value at Week 24.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and Week 24

ID	Title	Description
OG000	Teneli 5mg+Met	Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
OG001	Teneli 10mg+Met	Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
OG002	Teneli 20mg+Met	Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
OG003	Teneli 40mg+Met

Secondary

Adverse Events, Laboratory Tests, Vital Signs, Etc.

Not Posted

Weeks 24, 52

Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Teneli 5mg+Met	Teneligliptin 5mg plus Metformin	4	87	43	87
EG001	Teneli 10 mg+Met	Teneligliptin 10mg plus Metformin	4	93	43	93
EG002	Teneli 20 mg+Met	Teneligliptin 20mg plus Metformin	3	91	41	91
EG003	Teneli 40 mg+Met	Teneligliptin 40mg plus Metformin	5	88	36	88
EG004	Placebo+Met	Placebo plus Metformin	6	88	48	88

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
BRONCHITIS	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG0030 affected88 at risk EG0041 affected88 at risk
PNEUMONIA	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CEREBELLAR INFARCTION	Nervous system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
IIIRD NERVE PARALYSIS	Nervous system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
FEMORAL ARTERY OCCLUSION	Vascular disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
FATTY LIVER ALCOHOLIC	Hepatobiliary disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
HEPATIC STEATOSIS	Hepatobiliary disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
BRONCHITIS	Infections and infestations	MedDRA 13.1	EG0003 affected87 at risk EG0013 affected93 at risk EG0020 affected91 at risk EG0030 affected88 at risk EG0041 affected88 at risk
CYSTITIS	Infections and infestations	MedDRA 13.1	EG0002 affected87 at risk EG0014 affected93 at risk EG0021 affected91 at risk EG003
EAR INFECTION	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ERYSIPELAS	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
HERPES SIMPLEX	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
INFLUENZA	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
LARYNGITIS	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
MEASLES	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 13.1	EG0006 affected87 at risk EG0014 affected93 at risk EG0022 affected91 at risk EG003
ONYCHOMYCOSIS	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
OTITIS EXTERNA	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
PELVIC INFLAMMATORY DISEASE	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
PHARYNGITIS	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
RASH PUSTULAR	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
SINUSITIS	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
TINEA PEDIS	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
TOOTH ABSCESS	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
TRACHEOBRONCHITIS	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 13.1	EG0002 affected87 at risk EG0011 affected93 at risk EG0023 affected91 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 13.1	EG0002 affected87 at risk EG0013 affected93 at risk EG0022 affected91 at risk EG003
VIRAL INFECTION	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0011 affected93 at risk EG0021 affected91 at risk EG003
VULVAL ABSCESS	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
TOOTH INFECTION	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
ANAL ABSCESS	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
GINGIVAL INFECTION	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
GENITOURINARY TRACT INFECTION	Infections and infestations	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 13.1	EG0002 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
MELANOCYTIC NAEVUS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
ANAEMIA	Blood and lymphatic system disorders	MedDRA 13.1	EG0001 affected87 at risk EG0011 affected93 at risk EG0021 affected91 at risk EG003
HYPOCHROMIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
MICROCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
LYMPHATIC DISORDER	Blood and lymphatic system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
HYPOTHYROIDISM	Endocrine disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
AUTOIMMUNE THYROIDITIS	Endocrine disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
GOUT	Metabolism and nutrition disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 13.1	EG0002 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0023 affected91 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 13.1	EG0001 affected87 at risk EG0011 affected93 at risk EG0021 affected91 at risk EG003
OBESITY	Metabolism and nutrition disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
VITAMIN B12 DEFICIENCY	Metabolism and nutrition disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
VITAMIN D DEFICIENCY	Metabolism and nutrition disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
DYSLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA 13.1	EG0000 affected87 at risk EG0013 affected93 at risk EG0021 affected91 at risk EG003
HYPERLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CARPAL TUNNEL SYNDROME	Nervous system disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CEREBRAL ATROPHY	Nervous system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
DIABETIC NEUROPATHY	Nervous system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 13.1	EG0001 affected87 at risk EG0012 affected93 at risk EG0025 affected91 at risk EG003
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
MIGRAINE	Nervous system disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
SCIATICA	Nervous system disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
LACUNAR INFARCTION	Nervous system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CEREBROVASCULAR INSUFFICIENCY	Nervous system disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
CATARACT	Eye disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CONJUNCTIVITIS	Eye disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CONJUNCTIVITIS ALLERGIC	Eye disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
DIABETIC RETINOPATHY	Eye disorders	MedDRA 13.1	EG0001 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
EYE INFLAMMATION	Eye disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
GLAUCOMA	Eye disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
MACULAR DEGENERATION	Eye disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
PERIORBITAL OEDEMA	Eye disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
VERTIGO	Ear and labyrinth disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ANGINA PECTORIS	Cardiac disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0022 affected91 at risk EG003
AORTIC VALVE SCLEROSIS	Cardiac disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CARDIOMYOPATHY	Cardiac disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
HYPERTENSIVE HEART DISEASE	Cardiac disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
SINUS BRADYCARDIA	Cardiac disorders	MedDRA 13.1	EG0000 affected87 at risk EG0012 affected93 at risk EG0020 affected91 at risk EG003
TACHYCARDIA	Cardiac disorders	MedDRA 13.1	EG0000 affected87 at risk EG0012 affected93 at risk EG0020 affected91 at risk EG003
MITRAL VALVE SCLEROSIS	Cardiac disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
FLUSHING	Vascular disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA 13.1	EG0005 affected87 at risk EG0012 affected93 at risk EG0023 affected91 at risk EG003
VARICOSE ULCERATION	Vascular disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
VENOUS INSUFFICIENCY	Vascular disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
HOT FLUSH	Vascular disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0022 affected91 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
VASOMOTOR RHINITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0022 affected91 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 13.1	EG0001 affected87 at risk EG0011 affected93 at risk EG0021 affected91 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA 13.1	EG0002 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 13.1	EG0001 affected87 at risk EG0012 affected93 at risk EG0025 affected91 at risk EG003
DRY MOUTH	Gastrointestinal disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
GINGIVITIS	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0012 affected93 at risk EG0021 affected91 at risk EG003
REFLUX OESOPHAGITIS	Gastrointestinal disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 13.1	EG0001 affected87 at risk EG0012 affected93 at risk EG0021 affected91 at risk EG003
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
APICAL GRANULOMA	Gastrointestinal disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
HEPATIC STEATOSIS	Hepatobiliary disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
ACTINIC KERATOSIS	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CUTANEOUS SARCOIDOSIS	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
DERMAL CYST	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0021 affected91 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0012 affected93 at risk EG0020 affected91 at risk EG003
HYPERKERATOSIS	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0001 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
INGROWING NAIL	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
RASH PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
RASH PRURITIC	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0022 affected91 at risk EG003
RASH VESICULAR	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
SKIN EXFOLIATION	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
SKIN FISSURES	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ONYCHOCLASIS	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
PHOTODERMATOSIS	Skin and subcutaneous tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0012 affected93 at risk EG0020 affected91 at risk EG003
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0001 affected87 at risk EG0011 affected93 at risk EG0021 affected91 at risk EG003
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
HAEMARTHROSIS	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
JOINT EFFUSION	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0021 affected91 at risk EG003
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
SYNOVITIS	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
TENOSYNOVITIS STENOSANS	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
FOOT DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
GLYCOSURIA	Renal and urinary disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
MICROALBUMINURIA	Renal and urinary disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
POLLAKIURIA	Renal and urinary disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
RENAL COLIC	Renal and urinary disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
RENAL FAILURE CHRONIC	Renal and urinary disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
DIABETIC NEPHROPATHY	Renal and urinary disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
STRESS URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
EPIDIDYMITIS	Reproductive system and breast disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
OVARIAN CYST	Reproductive system and breast disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
CHEST PAIN	General disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0021 affected91 at risk EG003
FATIGUE	General disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
MALAISE	General disorders	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
PAIN	General disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
PYREXIA	General disorders	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
BLOOD CHOLESTEROL INCREASED	Investigations	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
BLOOD PRESSURE INCREASED	Investigations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
BLOOD TRIGLYCERIDES INCREASED	Investigations	MedDRA 13.1	EG0002 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
BLOOD UREA INCREASED	Investigations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA 13.1	EG0001 affected87 at risk EG0012 affected93 at risk EG0022 affected91 at risk EG003
CREATININE RENAL CLEARANCE DECREASED	Investigations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
CRYSTAL URINE PRESENT	Investigations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
HEART RATE IRREGULAR	Investigations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
PROTEIN URINE PRESENT	Investigations	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
URINE URIC ACID INCREASED	Investigations	MedDRA 13.1	EG0001 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
HEPATIC ENZYME INCREASED	Investigations	MedDRA 13.1	EG0000 affected87 at risk EG0012 affected93 at risk EG0020 affected91 at risk EG003
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
SOFT TISSUE INJURY	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
OPEN WOUND	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
LIGAMENT INJURY	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0021 affected91 at risk EG003
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA 13.1	EG0000 affected87 at risk EG0011 affected93 at risk EG0020 affected91 at risk EG003
ORCHIDECTOMY	Surgical and medical procedures	MedDRA 13.1	EG0000 affected87 at risk EG0010 affected93 at risk EG0020 affected91 at risk EG003

ID	Term
D003924	Diabetes Mellitus, Type 2
D007333	Insulin Resistance

ID	Term
D008687	Metformin

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0042 affected88 at risk

EG0040 affected88 at risk

EG0046 affected88 at risk

EG0040 affected88 at risk

EG0042 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0042 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0042 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0042 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0042 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0043 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0042 affected88 at risk

EG0041 affected88 at risk

EG0040 affected88 at risk

EG0042 affected88 at risk

EG0040 affected88 at risk

EG0042 affected88 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Aalborg			Denmark

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D006946	Hyperinsulinism

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals