Comparison of NN1250 With Insulin Glargine in Subjects Wi... | NCT01076647

ID	Type	Description	Link
2009-011399-31	EudraCT Number
U1111-1112-8770	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 3TW	Experimental		Drug: insulin degludec
IGlar OD	Active Comparator		Drug: insulin glargine

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Will be injected subcutaneously (under the skin) once daily three times weekly.	IDeg 3TW

Measure	Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c)	Change from baseline in HbA1c after 26 weeks of treatment	Week 0, Week 26

Measure	Description	Time Frame
Change in Body Weight	Change from baseline in body weight after 26 weeks of treatment	Week 0, Week 26

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		Birmingham	Alabama	35216	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24622318	Result	Zinman B, DeVries JH, Bode B, Russell-Jones D, Leiter LA, Moses A, Johansen T, Ratner R; NN1250-3724 (BEGIN:EASY AM) and NN1250-3718 (BEGIN:EASY PM) Trial Investigators. Efficacy and safety of insulin degludec three times a week versus insulin glargine once a day in insulin-naive patients with type 2 diabetes: results of two phase 3, 26 week, randomised, open-label, treat-to-target, non-inferiority trials. Lancet Diabetes Endocrinol. 2013 Oct;1(2):123-31. doi: 10.1016/S2213-8587(13)70013-5. Epub 2013 Jul 9.

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IDeg 3TW	Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
FG001	IGlar OD

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	IDeg 3TW	Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
BG001	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
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
	BG00057.3± 9.6 BG00157.5± 10.7 BG00257.4± 10.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000101 BG00199 BG002

Glycosylated haemoglobin (HbaA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.3± 0.8 BG0018.3± 0.8 BG002

Body Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00092.3± 18.3 BG00191.4± 18.7 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

Change in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 26 weeks of treatment

The Full analysis set (FAS) included 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 3TW	Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
OG001	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.

Units	Counts
Participants	OG000233 OG001234

Title

Denominators

Categories

Title	Measurements
	OG000-1.05± 0.94 OG001-1.36± 0.95

Secondary

Change in Body Weight

Change from baseline in body weight after 26 weeks of treatment

The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

Week 0, Week 26

ID	Title	Description
OG000	IDeg 3TW	Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
OG001	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IDeg 3TW	Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.			13	233	34	233
EG001	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.			12	234	25	234

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Angina unstable	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0011 events1 affected234 at risk
Cardiac asthma	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Tachycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Periodontitis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Erysipelas	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0012 events2 affected234 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Hyponatraemic syndrome	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Facial paresis	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Presyncope	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Vertigo CNS origin	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Depression	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Panic disorder	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Lithotripsy	Surgical and medical procedures	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Arteriosclerosis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected234 at risk
Hypotension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected234 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00013 events11 affected233 at risk EG00116 events13 affected234 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00014 events13 affected233 at risk EG0016 events6 affected234 at risk
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00018 events14 affected233 at risk EG0019 events8 affected234 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