Comparison of NN1250 With Sitagliptin in Subjects With Ty... | NCT01046110

ID	Type	Description	Link
U1111-1111-7126	Other Identifier	WHO

Status Module

Oversight Module

Label	Type	Description	Intervention Names
IDeg OD	Experimental		Drug: insulin degludec
DPP-IV inhibitor	Experimental		Drug: sitagliptin

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.	IDeg 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

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

PubMed Identifier	Type	Citation	Retractions
23577643	Result	Philis-Tsimikas A, Del Prato S, Satman I, Bhargava A, Dharmalingam M, Skjoth TV, Rasmussen S, Garber AJ. Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Diabetes Obes Metab. 2013 Aug;15(8):760-6. doi: 10.1111/dom.12115. Epub 2013 May 6.

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IDeg OD	Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	IDeg OD	Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
BG001	DPP-IV Inhibitor	Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
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
	BG00056.4± 10.2 BG00154.9± 11.4 BG00255.7± 10.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00084 BG001101 BG002

Glycosylated haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.8± 1.0 BG0019.0± 1.0 BG002

Fasting plasma glucose (FPG)

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0009.4± 2.6 BG0019.9± 3.1 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 was imputed using last observation carried forward (LOCF). A site was closed, hence 11 randomised subjects (4 subjects with IDeg; 7 subjects with DPP-IV group/arm) were excluded from the FAS.

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 26

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
OG001	DPP-IV Inhibitor	Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.

Units	Counts
Participants	OG000225 OG001222

Title

Denominators

Categories

Title	Measurements
	OG000-1.56± 1.09 OG001-1.22± 1.16

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 LOCF. One site was closed, hence 11 randomised subjects (4 in IDeg and 7 in DPP-IV group/arm) were excluded from the FAS. Fasting plasma glucose values were missing for another 8 subjects, hence did not contribute to the analysis.

Posted

Mean

Standard Deviation

mmol/L

Week 0, Week 26

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
OG001	DPP-IV Inhibitor	Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.

Units	Counts
Participants

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	Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).			14	226	44	226
EG001	DPP-IV Inhibitor	Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.			10	228	53	228

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected226 at risk EG0011 events1 affected228 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected226 at risk EG0011 events1 affected228 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected226 at risk EG0011 events1 affected228 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Diverticulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Lobar pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected226 at risk EG0011 events1 affected228 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected226 at risk EG0011 events1 affected228 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected226 at risk EG0011 events1 affected228 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected226 at risk EG0011 events1 affected228 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0011 events1 affected228 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected226 at risk EG0011 events1 affected228 at risk
Urinary retention	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 at risk EG0010 events0 affected228 at risk
Fallopian tube cyst	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected226 at risk EG0011 events1 affected228 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected226 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	EG00029 events13 affected226 at risk EG00127 events19 affected228 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0008 events8 affected226 at risk EG00114 events14 affected228 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00014 events13 affected226 at risk EG00122 events18 affected228 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00038 events24 affected226 at risk EG00124 events15 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
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines