Comparison of NN1250 With Insulin Glargine in Type 1 Diab... | NCT01079234

NCT01079234

ID	Type	Description	Link
U1111-1112-8813	Other Identifier	WHO
2009-012923-27	EudraCT Number

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
Flex + insulin aspart	Experimental	Drug: insulin degludec Drug: insulin aspart
Fixed + insulin aspart	Experimental	Drug: insulin degludec Drug: insulin aspart
IGlar + insulin aspart	Active Comparator	Drug: insulin glargine Drug: insulin aspart

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Injected subcutaneously (under the skin) once daily	Fixed + insulin aspart Flex + insulin aspart

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment	Change from baseline in HbA1c after 26 weeks of treatment	Week 0, Week 26
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 52 + 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 52 + 7 days follow up

Secondary Outcomes

Measure	Description	Time Frame
Extension Trial (Secondary 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
Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment

Eligibility Module

Contacts/Locations 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		Encino	California	91436	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

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	IDeg OD FF	Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.

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

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	IDeg OD FF	Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
BG001	IDeg OD	Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
BG002	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00042.6± 13.4 BG00144.5± 13.1 BG00244.1± 12.6 BG003

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00062 BG00171 BG002

HbA1c (glycosylated haemoglobin)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0007.7± 1.0 BG0017.7± 0.9 BG002

Fasting plasma glucose (FPG)

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0009.6± 4.1 BG00110.0± 4.0 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 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment

Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 26

ID	Title	Description
OG000	IDeg OD FF	Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
OG001	IDeg OD	Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
OG002	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.

Units	Counts
Participants	OG000164 OG001165 OG002164

Title

Denominators

Categories

Title	Measurements
	OG000-0.40± 0.59 OG001-0.41± 0.71 OG002-0.58± 0.72

Secondary

Extension Trial (Secondary 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) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 52

ID	Title	Description
OG000	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
OG001	IDeg OD F	The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.

Secondary

Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment

Change from baseline in FPG after 26 weeks of treatment

Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 6 subjects baseline values were missing.

Posted

Mean

Standard Deviation

mmol/L

Week 0, Week 26

ID	Title	Description
OG000	IDeg OD FF	Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
OG001	IDeg OD	Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
OG002	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.

Secondary

Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

Change from baseline in FPG after 52 weeks of treatment.

Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). FPG baseline values were missing for 6 subjects. The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.

Posted

Mean

Standard Deviation

mmol/L

Week 0, Week 52

ID	Title	Description
OG000	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
OG001	IDeg OD F	The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.

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 includes all subjects who received at least one dose of the investigational product or its comparator. The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 52 + 7 days follow up

ID	Title	Description
OG000	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
OG001	IDeg OD F	The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.

Primary

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

Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 52 + 7 days follow up

ID	Title	Description
OG000	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
OG001	IDeg OD F	The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.

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 F	The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.			25	329	187	329
EG001	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.			12	161	105	161

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Retinal haemorrhage	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Abscess limb	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Pyelonephritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Incorrect dose administered	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected161 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected161 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG00012 events8 affected329 at risk EG0014 events4 affected161 at risk
Hypoglycaemic seizure	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected161 at risk
Hypoglycaemic unconsciousness	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0005 events5 affected329 at risk EG0014 events4 affected161 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected161 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected161 at risk
Transient global amnesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Completed suicide	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Gastritis alcoholic	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Abdominal infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected161 at risk
In-stent arterial restenosis	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected161 at risk
Vascular pseudo aneurysm	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected161 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Hyper osmolar state	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected161 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00015 events9 affected329 at risk EG00115 events12 affected161 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00021 events18 affected329 at risk EG00113 events8 affected161 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00022 events18 affected329 at risk EG00112 events11 affected161 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00022 events19 affected329 at risk EG0016 events6 affected161 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000174 events99 affected329 at risk EG00185 events48 affected161 at risk
Sinusitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00028 events23 affected329 at risk EG00118 events13 affected161 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00039 events28 affected329 at risk EG00130 events21 affected161 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG00019 events18 affected329 at risk EG0018 events7 affected161 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG00038 events24 affected329 at risk EG00142 events13 affected161 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00061 events33 affected329 at risk EG00148 events24 affected161 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00020 events17 affected329 at risk EG00113 events11 affected161 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00036 events28 affected329 at risk EG00115 events14 affected161 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00011 events9 affected329 at risk EG00114 events10 affected161 at risk

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
C571886	insulin degludec
D000069036	Insulin Glargine
D061267	Insulin Aspart

Ancestor Terms

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

Units	Counts
Participants	OG000162 OG001325