Comparison of NN1250 With Insulin Glargine in Subjects Wi... | NCT01068678

ID	Type	Description	Link
2009-011398-33	EudraCT Number
U1111-1113-2412	Other Identifier	WHO

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
IDeg 3 times weekly (3TW)	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) three times weekly. Dose was individually adjusted.	IDeg 3 times weekly (3TW)

Measure	Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c)	Change from baseline in HbA1c after week 26	Week 26

Measure	Description	Time Frame
Change in Body Weight	Change from baseline in body weight after week 26	Week 26

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily) -Insulin secretaguogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 45.0 kg/m^2

Exclusion Criteria:

Use within the last 3 months prior to Visit 1 of: thiazoledinediones, exenatide or liraglutide
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)

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		Northridge	California	91325	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) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment 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) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
BG001	IGlar OD	Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment 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
	BG00058.4± 9.9 BG00157.9± 9.7 BG00258.1± 9.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000105 BG00193 BG002

Glycosylated haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.2± 0.8 BG0018.3± 0.9 BG002

Body weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00090.8± 18.6 BG00195.7± 19.0 BG002

Fasting Plasma Glucose

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0009.3± 2.4 BG0019.6± 2.4 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 week 26

The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).1 subject was randomised despite being a screening failure.

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 26

ID	Title	Description
OG000	IDeg 3TW	Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
OG001	IGlar OD	Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.

Units	Counts
Participants	OG000229 OG001230

Title

Denominators

Categories

Title	Measurements
	OG000-1.00± 0.95 OG001-1.40± 1.07

Secondary

Change in Body Weight

Change from baseline in body weight after week 26

The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.

Posted

Mean

Standard Deviation

Week 26

ID	Title	Description
OG000	IDeg 3TW	Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
OG001	IGlar OD	Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment 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) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.			11	227	69	227
EG001	IGlar OD	Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.			4	229	77	229

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected227 at risk EG0010 events0 affected229 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected229 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected229 at risk
Appendicitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected229 at risk
Cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected229 at risk
Diverticulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected229 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected229 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected229 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected229 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected229 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected229 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected229 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected227 at risk EG0010 events0 affected229 at risk
Renal colic	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected227 at risk EG0011 events1 affected229 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected227 at risk EG0010 events0 affected229 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00017 events16 affected227 at risk EG00120 events17 affected229 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00012 events12 affected227 at risk EG00116 events15 affected229 at risk
Injection site haematoma	General disorders	MedDRA 13.1	Systematic Assessment	EG00015 events11 affected227 at risk EG00112 events12 affected229 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00016 events15 affected227 at risk EG00118 events17 affected229 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0005 events5 affected227 at risk EG00119 events16 affected229 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG00018 events14 affected227 at risk EG00121 events14 affected229 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00038 events26 affected227 at risk EG00126 events21 affected229 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