Comparison of NN1250 With Insulin Glargine Plus Insulin A... | NCT00972283

NCT00972283

ID	Type	Description
2008-005777-35	EudraCT Number
U1111-1111-8648	Other Identifier	WHO
2009-015816-17	EudraCT Number
U1111-1114-9067	Other Identifier	WHO

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
IDeg OD	Experimental		Drug: insulin degludec Drug: insulin aspart
IGlar OD	Active Comparator		Drug: insulin glargine Drug: insulin aspart

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Injected subcutaneously (under the skin) with main evening meal. Dose was individually adjusted.	IDeg OD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment	Change from baseline in HbA1c after 52 weeks of treatment	Week 0, Week 52
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.	Week 0 to Week 78 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.	Week 0 to Week 78 + 7 days follow up
Rate of Treatment Emergent Adverse Events (AEs)	Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

Secondary Outcomes

Measure	Description	Time Frame
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment	Change from baseline in HbA1c after 78 weeks of treatment	Week 0, Week 78
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52

Eligibility Module

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Alexander City	Alabama	35010	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23130654	Result	Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.
26484727	Result

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
BG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
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

Title	Measurements
	BG00059.2± 9.1 BG00158.1± 10.0 BG00258.9± 9.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000339 BG001115 BG002

Glycosylated Haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.3± 0.8 BG0018.4± 0.9 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

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment

Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF)

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 52

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

Units	Counts
Participants	OG000744 OG001248

Title

Denominators

Categories

Title	Measurements
	OG000-1.17± 1.03 OG001-1.29± 0.98

Secondary

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment

Change from baseline in HbA1c after 78 weeks of treatment

The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 78

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

Units	Counts

Secondary

Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52

Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.

The FAS included all randomised subjects and missing data was imputed using LOCF. For 36 subjects all 9-point SMPG values were missing.

Posted

Mean

Standard Deviation

mmol/L

Week 52

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

Secondary

Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78

Mean of the SMPG at 78 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am, before breakfast.

The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 36 subjects all 9-point SMPG values were missing.

Posted

Mean

Standard Deviation

mmol/L

Week 78

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

Primary

Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.

Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 78 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

Primary

Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 78 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

Primary

Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Events/100 years of patient exposure

Week 0 to Week 78 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

Secondary

Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 52 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

Secondary

Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 52 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.

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	IDeg OD	Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.			139	753	447	753
EG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.			53	251	146	251

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0012 events1 affected251 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0005 events5 affected753 at risk EG0010 events0 affected251 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0003 events3 affected753 at risk EG0010 events0 affected251 at risk
Angina unstable	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0003 events3 affected753 at risk EG0010 events0 affected251 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0011 events1 affected251 at risk
Bradycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cardiac arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0010 events0 affected251 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0013 events3 affected251 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Coronary artery disease	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0009 events8 affected753 at risk EG0013 events3 affected251 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0012 events2 affected251 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0012 events2 affected251 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0003 events3 affected753 at risk EG0010 events0 affected251 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Corneal dystrophy	Congenital, familial and genetic disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cataract	Eye disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Diabetic retinopathy	Eye disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Chest discomfort	General disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0010 events0 affected251 at risk
Chest pain	General disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0011 events1 affected251 at risk
Gait disturbance	General disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Medical device complication	General disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Non-cardiac chest pain	General disorders	MedDRA 14.0	Systematic Assessment		EG0004 events4 affected753 at risk EG0010 events0 affected251 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0010 events0 affected251 at risk
Gallbladder pain	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Abscess jaw	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0010 events0 affected251 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0011 events1 affected251 at risk
Diabetic foot infection	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Endocarditis	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0011 events1 affected251 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0010 events0 affected251 at risk
Incision site abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Infected sebaceous cyst	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0011 events1 affected251 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0011 events1 affected251 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Salmonella sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Tracheobronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Wound infection	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0011 events1 affected251 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0011 events1 affected251 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0010 events0 affected251 at risk
Blood creatinine increased	Investigations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cardiac murmur	Investigations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Oxygen saturation decreased	Investigations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment		EG00013 events13 affected753 at risk EG0012 events2 affected251 at risk
Hypoglycaemia unawareness	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Hypoglycaemic seizure	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Hypoglycaemic unconsciousness	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment		EG00010 events6 affected753 at risk EG0011 events1 affected251 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0010 events0 affected251 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Bone neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0011 events1 affected251 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Colon cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Penis carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0003 events3 affected753 at risk EG0010 events0 affected251 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Facial nerve disorder	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Hemiparesis	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0003 events3 affected753 at risk EG0011 events1 affected251 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Confusional state	Psychiatric disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Depression suicidal	Psychiatric disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Eating disorder	Psychiatric disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment		EG0003 events3 affected753 at risk EG0011 events1 affected251 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0014 events3 affected251 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Pneumothorax spontaneous tension	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Arteriosclerosis	Vascular disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment		EG0003 events3 affected753 at risk EG0011 events1 affected251 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Pericarditis	Cardiac disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Tympanic membrane disorder	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Adhesion	General disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Death	General disorders	MedDRA 14.0	Systematic Assessment	Cause: Unknown	EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cholecystitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cholecystitis acute	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected753 at risk EG0010 events0 affected251 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Food allergy	Immune system disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cholecystitis infective	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Herpes zoster	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Implant site infection	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Mastoiditis	Ear and labyrinth disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Pyelonephritis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0011 events1 affected251 at risk
Fibular fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
B cell lymphoma stage-1	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Metastasis to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Tongue carcinoma stage-1	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Inter capillary glomerulosclerosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Gastric bypass	Surgical and medical procedures	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk
Diastolic hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected753 at risk EG0011 events1 affected251 at risk
Autoimmune thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected753 at risk EG0010 events0 affected251 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00073 events59 affected753 at risk EG00131 events26 affected251 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Systematic Assessment	EG00069 events55 affected753 at risk EG00120 events17 affected251 at risk
Influenza	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00068 events58 affected753 at risk EG00123 events20 affected251 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG000212 events124 affected753 at risk EG00161 events37 affected251 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG000212 events123 affected753 at risk EG00170 events42 affected251 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG00066 events58 affected753 at risk EG0019 events9 affected251 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00055 events43 affected753 at risk EG00136 events26 affected251 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00066 events56 affected753 at risk EG00125 events21 affected251 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00055 events47 affected753 at risk EG00119 events19 affected251 at risk
Headache	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG000153 events71 affected753 at risk EG00132 events20 affected251 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00071 events61 affected753 at risk EG00129 events21 affected251 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG00059 events50 affected753 at risk EG00115 events14 affected251 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00039 events28 affected753 at risk EG00120 events14 affected251 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00045 events39 affected753 at risk EG00118 events15 affected251 at risk
Bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00064 events49 affected753 at risk EG00119 events13 affected251 at risk
Sinusitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00064 events45 affected753 at risk EG00121 events18 affected251 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

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

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061266	Insulin, Short-Acting

ID	Term
C571886	insulin degludec
D000069036	Insulin Glargine
D061267	Insulin Aspart