Comparison of NPH Insulin and Insulin Detemir in Children... | NCT00435019

NCT00435019

ID	Type	Description	Link
2006-000051-18	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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
insulin detemir	Experimental	insulin detemir + insulin aspart	Drug: insulin detemir Drug: insulin aspart
NPH insulin	Experimental	NPH insulin + insulin aspart	Drug: insulin NPH Drug: insulin aspart

Name	Type	Description	Arm Group Labels	Other Names
insulin detemir	Drug	s.c. injection, once or twice daily.	insulin detemir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycosylated Haemoglobin A1c (HbA1c)	Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.	after 52 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects Reporting Adverse Events	Number of subjects reporting adverse events during the trial (from week -2 to week 52). For details, please refer to the adverse events section.	from week -2 to week 52
Observed Insulin Antibody Values

Eligibility Module

Contacts/Locations 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		Pleven		5800	Bulgaria
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21418455	Result	Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes. 2011 Nov;12(7):632-41. doi: 10.1111/j.1399-5448.2010.00750.x. Epub 2011 Mar 21.
23094597	Result	Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial. Diabet Med. 2013 Feb;30(2):216-25. doi: 10.1111/dme.12041.

Label	URL
Clinical Trials at Novo Nordisk	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Insulin Detemir	Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
FG001	NPH Insulin

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.

Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals

FG000177 subjectsRandomised

FG001171 subjectsRandomised

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Insulin Detemir	Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
BG001	NPH Insulin	Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
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	BG000177 BG001170 BG002347
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00010.0± 4.09 BG0019.8± 3.90 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00094 BG00173 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)

Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.

Full Analysis Set (FAS) is defined as all randomised subjects exposed to at least one dose of trial product with a postbaseline observation, classified according to randomised treatment.

Posted

Mean

Standard Error

Percent (%) glycosylated haemoglobin

after 52 weeks of treatment

ID	Title	Description
OG000	Insulin Detemir	Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
OG001	NPH Insulin	Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals

Units	Counts
Participants	OG000171 OG001168

Title

Denominators

Categories

Title	Measurements
	OG0008.75± 0.11 OG0018.64± 0.11

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		ANCOVA				Mean Difference (Final Values)	0.12				95	-0.12	0.36					Non-Inferiority or Equivalence	The null hypothesis for the non-inferiority test was that the mean HbA1c with insulin detemir was greater than or equal to the mean HbA1c with NPH insulin plus 0.4%. A sample size of 344 subjects, in total, with a drop-out rate of 20 percent would yield 274 subjects for evaluation of HbA1c. This would give 85 percent power to detect a difference in means of HbA1c of 0.4 percentage points assuming that the standard deviation was 1.1 using a two-sided t-test with a 0.05 significance level.

Secondary

Number of Subjects Reporting Adverse Events

Number of subjects reporting adverse events during the trial (from week -2 to week 52).

For details, please refer to the adverse events section.

Safety analysis set (SAS): all randomised subjects exposed to at least one dose of trial product, classified according to actual treatment.

Posted

Number

participants

from week -2 to week 52

ID	Title	Description
OG000	Insulin Detemir	Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
OG001	NPH Insulin	Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals

Units	Counts
Participants	OG000

Secondary

Observed Insulin Antibody Values

Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.

Safety analysis set (SAS): All randomised subjects exposed to at least one dose of trial product, classified according to actual treatment. In some cases, antibody samples were taken earlier than required. These results were not included. A shipment of antibody samples was lost during transportation, and thus these antibody data were missing.

Posted

Mean

Standard Deviation

Percent bound of total

at 0 and 52 weeks

ID	Title	Description
OG000	Insulin Detemir	Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
OG001	NPH Insulin	Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals

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	Insulin Detemir	Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals			14	177	131	177
EG001	NPH Insulin	Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals			20	170	134	170

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected177 at risk EG0014 events4 affected170 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected177 at risk EG0013 events3 affected170 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected177 at risk EG0011 events1 affected170 at risk
Hypoglycaemic Unconsciousness	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected177 at risk EG0013 events2 affected170 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected177 at risk EG0012 events2 affected170 at risk
Viral Infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected177 at risk EG0011 events1 affected170 at risk
Gastroenteritis Shigella	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected177 at risk EG0010 events0 affected170 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected177 at risk EG0011 events1 affected170 at risk
Laryngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected177 at risk EG0011 events1 affected170 at risk
Otitis Media Acute	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected177 at risk EG0010 events0 affected170 at risk
Soft Tissue Infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected177 at risk EG0010 events0 affected170 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected177 at risk EG0011 events1 affected170 at risk
Gastritis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected177 at risk EG0012 events2 affected170 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected177 at risk EG0010 events0 affected170 at risk
Burns Second Degree	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected177 at risk EG0010 events0 affected170 at risk
Medication Error	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected177 at risk EG0011 events1 affected170 at risk
Convulsion	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected177 at risk EG0011 events1 affected170 at risk
Epilepsy	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected177 at risk EG0011 events1 affected170 at risk
Nephropathy	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected177 at risk EG0011 events1 affected170 at risk
Adenoidal Hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected177 at risk EG0011 events1 affected170 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG000147 events75 affected177 at risk EG001179 events81 affected170 at risk
Pharyngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00029 events19 affected177 at risk EG00116 events15 affected170 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00032 events18 affected177 at risk EG00132 events16 affected170 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00020 events15 affected177 at risk EG00113 events12 affected170 at risk
Influenza	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00014 events10 affected177 at risk EG00125 events18 affected170 at risk
Viral Infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00014 events12 affected177 at risk EG00117 events14 affected170 at risk
Bronchitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00011 events9 affected177 at risk EG00115 events12 affected170 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00010 events9 affected177 at risk EG0017 events7 affected170 at risk
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG00065 events26 affected177 at risk EG00144 events23 affected170 at risk

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000069057	Insulin Detemir
D007336	Insulin, Isophane
D061267	Insulin Aspart

Ancestor Terms

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

BG0000
BG0010
BG0020