Comparison of NN1250 With Insulin Glargine in Subjects Wi... | NCT01068665

ID	Type	Description	Link
2009-010662-28	EudraCT Number
U1111-1112-8977	Other Identifier	WHO

Status Module

Oversight Module

Label	Type	Description	Intervention Names
IDeg 200 U/mL 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 200 U/mL OD

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 Fasting Plasma Glucose (FPG)	Change from baseline in FPG after 26 weeks of treatment	Week 0, 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 an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 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 secretagogue (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-inhibitors (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) maximum 45.0 kg/m^2
Type 2 diabetes (diagnosed clinically) for at least 6 months
Ability and willingness to adhere to the protocol including performance of self monitored plasma glucose (SMPG) profiles according to the protocol

Exclusion Criteria:

Use within the last 3 months prior to Visit 1 of: thiazoledinediones (TZDs), 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		Huntsville	Alabama	35801	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27764979	Result	Weatherall J, Bloudek L, Buchs S. Budget impact of treating commercially insured type 1 and type 2 diabetes patients in the United States with insulin degludec compared to insulin glargine. Curr Med Res Opin. 2017 Feb;33(2):231-238. doi: 10.1080/03007995.2016.1251893. Epub 2016 Nov 18.
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.

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IDeg 200 U/mL OD	Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination 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 200 U/mL OD	Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
BG001	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination 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
	BG00057.8± 9.0 BG00157.3± 9.4 BG00257.5± 9.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000109 BG001105 BG002

Glycosylated haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.3± 1.0 BG0018.2± 0.9 BG002

Fasting plasma glucose (FPG)

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0009.6± 2.9 BG0019.7± 2.6 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

Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF). 2 subjects were withdrawn prior to exposure to the study drug in the IDeg arm as they were randomised in error and 1 subject in the IGlar arm.

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 26

ID	Title	Description
OG000	IDeg 200 U/mL OD	Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
OG001	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.

Units	Counts
Participants	OG000228 OG001229

Title

Denominators

Categories

Title	Measurements
	OG000-1.30± 1.04 OG001-1.32± 0.98

Secondary

Change in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 26 weeks of treatment

The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.

Posted

Mean

Standard Deviation

mmol/L

Week 0, Week 26

ID	Title	Description
OG000	IDeg 200 U/mL OD	Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
OG001	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination 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 200 U/mL OD	Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.			15	228	51	228
EG001	IGlar OD	Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.			10	228	60	228

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Angina unstable	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Coronary artery disease	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected228 at risk EG0010 events0 affected228 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected228 at risk EG0010 events0 affected228 at risk
Polyp	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Arthritis bacterial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Campylobacter infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Herpes zoster	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Localised infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected228 at risk EG0010 events0 affected228 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Traumatic shock	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected228 at risk EG0010 events0 affected228 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Anxiety	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk
Renal failure	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected228 at risk EG0011 events1 affected228 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected228 at risk EG0010 events0 affected228 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00024 events17 affected228 at risk EG00122 events19 affected228 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00018 events17 affected228 at risk EG00113 events12 affected228 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0007 events7 affected228 at risk EG00118 events15 affected228 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00027 events20 affected228 at risk EG00136 events24 affected228 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