Comparison of NN1250 Versus Insulin Glargine in Subjects... | NCT00982644

ID	Type	Description
2008-005776-27	EudraCT Number
U1111-1111-8692	Other Identifier	WHO
2009-015754-38	EudraCT Number
U1111-1114-9426	Other Identifier	WHO

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

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

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 104 + 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 104 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)	Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: 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.

Measure	Description	Time Frame
Main Trial (Secondary 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.

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		Bay Minette	Alabama	36507-4198	United States
Novo Nordisk Investigational Site

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.
24170235	Result

Label	URL
Clinical Trials at Novo Nordisk	View source

ID	Title	Description
FG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
FG001	IGlar OD

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

The 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 (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.

Units	Counts
Participants	OG000773 OG001257

Title

Denominators

Categories

Title	Measurements
	OG000-1.06± 1.01 OG001-1.19± 0.97

Secondary

Main Trial (Secondary 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.

The safety analysis set (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 (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.

Primary

Extension Trial (Primary Endpoint): Rate of 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 104 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 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 104 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.

Secondary

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment

Change from baseline in HbA1c after 104 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 104

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.

Units	Counts
Participants

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 126 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 (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.

Units	Counts

Secondary

Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104

Mean of 9-point SMPG at 104 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 in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 140 subjects all 9-point SMPG values were missing.

Posted

Mean

Standard Deviation

mmol/L

Week 104

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 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 (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.

Primary

Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: 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 in the main trial including subjects carried through to the extension trial.

Posted

Number

Events/100 years of patient exposure

Week 0 to Week 104 + 7 days of follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0004 events4 affected766 at risk EG0010 events0 affected257 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0004 events4 affected766 at risk EG0013 events2 affected257 at risk
Angina unstable	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0004 events4 affected766 at risk EG0012 events2 affected257 at risk
Atrial flutter	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0011 events1 affected257 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0003 events2 affected766 at risk EG0010 events0 affected257 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0004 events3 affected766 at risk EG0012 events2 affected257 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Coronary artery disease	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG00011 events10 affected766 at risk EG0010 events0 affected257 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0011 events1 affected257 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0003 events3 affected766 at risk EG0012 events2 affected257 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0003 events3 affected766 at risk EG0012 events2 affected257 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0002 events1 affected766 at risk EG0010 events0 affected257 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Lens dislocation	Eye disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Chest pain	General disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Hernia	General disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Appendicitis	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Bronchopneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Cellulitis	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Diverticulitis	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0011 events1 affected257 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Influenza	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Lobar pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0004 events4 affected766 at risk EG0012 events2 affected257 at risk
Pneumonia primary atypical	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Urosepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Vaginal infection	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Wound infection	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0011 events1 affected257 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0012 events2 affected257 at risk
Hypoglycaemic unconsciousness	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment		EG0003 events3 affected766 at risk EG0012 events2 affected257 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Bladder adenocarcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0011 events1 affected257 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Prostate cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0011 events1 affected257 at risk
Aphasia	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Cerebral infarction	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Cerebrospinal fistula	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Syncope	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0003 events3 affected766 at risk EG0011 events1 affected257 at risk
Thalamic infarction	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0011 events1 affected257 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Hypertensive crisis	Vascular disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0012 events2 affected257 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Acute myocardial ischaemia	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0005 events5 affected766 at risk EG0011 events1 affected257 at risk
Cardiac arrest	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 affected257 at risk
Cardiomyopathy	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Myocardial ishaemia	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Macular oedema	Eye disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Retinal haemorrhage	Eye disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Gastric polyp	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Large intestinal perforation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Lower grastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Death	General disorders	MedDRA 14.1	Systematic Assessment	Cause: Unknown	EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Multiorgan failure	General disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Non-cardiac chest pain	General disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0011 events1 affected257 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Cholelithiasis obstructive	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Abdominal abscess	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Diabetic foot	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Herpes zoster	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Meningitis listeria	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Skin graft infection	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0011 events1 affected257 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0012 events1 affected257 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Diabetic foot	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Rotator cuff syndrome	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Benign neoplasm of prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Bronchoalveolar carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Colon carcinoma stage 3	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Diffuse large B cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Prostate carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0011 events1 affected257 at risk
Rectal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0011 events1 affected257 at risk
Renal cell carcinoma stage 1	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Cerebro vascular accident	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0005 events4 affected766 at risk EG0010 events0 affected257 at risk
Embolic cerebral infarction	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0002 events2 affected766 at risk EG0010 events0 affected257 at risk
Sciatica	Nervous system disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Renal cyst	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 at risk
Urinary retention	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0011 events1 affected257 at risk
Nasal polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment		EG0001 events1 affected766 at risk EG0010 events0 affected257 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Systematic Assessment		EG0000 events0 affected766 at risk EG0011 events1 affected257 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

ID	Title	Description
BG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
BG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
BG002	Total	Total of all reporting 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 (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.			116	766	463	766
EG001	IGlar OD	Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.			41	257	153	257

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG000126 events83 affected766 at risk EG00136 events28 affected257 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00044 events34 affected766 at risk EG00120 events17 affected257 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00099 events70 affected766 at risk EG00123 events20 affected257 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG000310 events183 affected766 at risk EG001108 events65 affected257 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG000121 events78 affected766 at risk EG00133 events19 affected257 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG000129 events76 affected766 at risk EG00139 events23 affected257 at risk
Headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG000192 events106 affected766 at risk EG00157 events30 affected257 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00080 events61 affected766 at risk EG00120 events14 affected257 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00055 events41 affected766 at risk EG00117 events11 affected257 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Systematic Assessment	EG00055 events46 affected766 at risk EG00112 events11 affected257 at risk
Gastroenteritis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00040 events34 affected766 at risk EG00116 events15 affected257 at risk
Influenza	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00050 events44 affected766 at risk EG00118 events13 affected257 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00064 events45 affected766 at risk EG00117 events14 affected257 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00057 events45 affected766 at risk EG00114 events12 affected257 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00037 events30 affected766 at risk EG00114 events13 affected257 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00053 events44 affected766 at risk EG00111 events11 affected257 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00040 events31 affected766 at risk EG00118 events14 affected257 at risk