Comparison of the Blood Sugar Lowering Effect and Safety... | NCT00537303

ID	Type	Description	Link
2007-000123-18	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Advanced	Experimental	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.	Drug: insulin detemir Drug: insulin aspart
Basic	Active Comparator	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.	Drug: insulin detemir Drug: insulin aspart

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin detemir	Drug	Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)	Advanced Basic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycosylated Haemoglobin A1c (HbA1c)	Analysed for the full analysis set.	week 36
Glycosylated Haemoglobin A1c (HbA1c)	Measured for the Per Protocol analysis set.	week 36

Secondary Outcomes

Measure	Description	Time Frame
Hypoglycaemic Episodes	Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.	Weeks 0-36

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		Fresno	California	93720	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21550957	Result	Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. Endocr Pract. 2011 Sep-Oct;17(5):727-36. doi: 10.4158/EP10367.OR.

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Advanced	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Advanced	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
BG001	Basic	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.3± 8.29 BG00158.3± 8.54 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00070 BG00167 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00026 BG00134 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Height

Mean

Standard Deviation

meter

Title

Denominators

Categories

Title	Measurements
	BG0001.68± 0.10 BG0011.67± 0.10 BG002

Body weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00088.8± 15.8 BG00188.0± 16.3 BG002

BMI (Body Mass Index)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00031.26± 4.26 BG00131.38± 4.92 BG002

Stratification

Number

participants

Title

Denominators

Categories

Metformin alone

Title	Measurements
	BG00062 BG00164 BG002

HbA1c (glycosylated haemoglobin A1c)

Mean

Standard Deviation

percentage (%) of total haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.89± 1.16 BG0018.67± 0.97 BG002

Diabetes history

Number of years since diagnosis

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00011.82± 5.99 BG00112.68± 6.68 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

Glycosylated Haemoglobin A1c (HbA1c)

Analysed for the full analysis set.

Full analysis set (FAS) is all randomised subjects exposed to at least one dose of trial products.

Posted

Least Squares Mean

Standard Error

percentage (%) of total haemoglobin

week 36

ID	Title	Description
OG000	Advanced	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
OG001	Basic	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Units	Counts
Participants	OG000140 OG001147

Title

Denominators

Categories

Title	Measurements
	OG0007.67± 0.09 OG0017.61± 0.08

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.	ANCOVA	Regimen, country and previous oral antidiabetic drug (OAD) use as factors and baseline HbA1c as covariate.	0.606	P-value for test of difference between treatments.	Mean Difference (Final Values)	0.06				95	-0.17	0.29					Non-Inferiority or Equivalence	The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the full analysis set and the per protocol set

Primary

Glycosylated Haemoglobin A1c (HbA1c)

Measured for the Per Protocol analysis set.

Per Protocol analysis set: All exposed subjects who completed the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the efficacy results.

Posted

Least Squares Mean

Standard Error

percentage (%) of total haemoglobin

week 36

ID	Title	Description
OG000	Advanced	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
OG001	Basic	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Secondary

Hypoglycaemic Episodes

Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.

Posted

Number

episodes

Weeks 0-36

ID	Title	Description
OG000	Advanced	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
OG001	Basic	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Secondary

Biochemistry: Serum Alanine Aminotransferase

Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.

Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.

Posted

Mean

Standard Deviation

U/L

week 36

ID	Title	Description
OG000	Advanced	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
OG001	Basic	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Units	Counts

Secondary

Haematology: Haemoglobin Measured in Blood

Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.

Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.

Posted

Mean

Standard Deviation

mmol/L

week 36

ID	Title	Description
OG000	Advanced	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
OG001	Basic	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Units	Counts

Secondary

Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide

High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.

Safety Analysis Set is all randomised subjects exposed to at least one dose of trial products.

Posted

Mean

Standard Deviation

mg/L

week 36

ID	Title	Description
OG000	Advanced	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
OG001	Basic	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Units	Counts

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	Advanced	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.			4	146	54	146
EG001	Basic	Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.			8	150	58	150

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected146 at risk EG0010 events0 affected150 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected146 at risk EG0011 events1 affected150 at risk
Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected146 at risk EG0011 events1 affected150 at risk
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected146 at risk EG0011 events1 affected150 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected146 at risk EG0011 events1 affected150 at risk
Cardiac Failure	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected146 at risk EG0011 events1 affected150 at risk
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected146 at risk EG0010 events0 affected150 at risk
Diabetic Foot Infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected146 at risk EG0011 events1 affected150 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected146 at risk EG0011 events1 affected150 at risk
Duodenal Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected146 at risk EG0010 events0 affected150 at risk
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected146 at risk EG0011 events1 affected150 at risk
Accidental Overdose	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected146 at risk EG0011 events1 affected150 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00024 events21 affected146 at risk EG00122 events17 affected150 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG00011 events8 affected146 at risk EG0017 events5 affected150 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0007 events6 affected146 at risk EG0018 events8 affected150 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG00019 events13 affected146 at risk EG00113 events10 affected150 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 events4 affected146 at risk EG0018 events8 affected150 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0008 events8 affected146 at risk EG00110 events10 affected150 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
D000069057	Insulin Detemir
D061267	Insulin Aspart

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