A Trial Investigating the Efficacy and Safety of Insulin... | NCT01513473

ID	Type	Description
2011-003148-39	EudraCT Number
P/44/2010	Other Identifier	EMA (PDCO)
U1111-1122-4758	Other Identifier	WHO

Label	Type	Description	Intervention Names
Insulin Degludec + Insulin Aspart	Experimental		Drug: insulin degludec Drug: insulin aspart
Insulin Detemir +Insulin Aspart	Experimental		Drug: insulin detemir Drug: insulin aspart

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Injected subcutaneously (under the skin) once daily. Dose individually adjusted.	Insulin Degludec + Insulin Aspart

Measure	Description	Time Frame
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)	Change from baseline in HbA1c (%) after 26 weeks of treatment.	Week 0, week 26

Measure	Description	Time Frame
Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)	Change from baseline in HbA1c (%) after 52 weeks of treatments.	Week 0, week 52
Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)

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		Little Rock	Arkansas	72202	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
30666772	Background	Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10.
25683037

Label	URL
Clinical Trials at Novo Nordisk	View source

ID	Title	Description
FG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.

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 From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)

Change from baseline in HbA1c (%) after 26 weeks of treatment.

Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, week 26

ID	Title	Description
OG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
OG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Units	Counts
Participants	OG000174 OG001176

Title

Denominators

Categories

Title	Measurements
	OG000-0.20± 0.95 OG001-0.31± 0.89

Secondary

Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)

Change from baseline in HbA1c (%) after 52 weeks of treatments.

Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, week 52

ID	Title	Description
OG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
OG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Secondary

Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)

Change from baseline in FPG after 26 weeks of treatment.

Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks. FPG samples were missing for 9 subjects.

Posted

Mean

Standard Deviation

mmol/L

Week 0, week 26

ID	Title	Description
OG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
OG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Secondary

Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)

Change from baseline in FPG after 52 weeks of treatment.

Posted

Mean

Standard Deviation

mmol/L

Week 0, week 52

ID	Title	Description
OG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
OG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Secondary

Number of Treatment Emergent Adverse Events (TEAEs)

TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.

Safety analysis set included all subjects receiving at least one dose of investigational product.

Posted

Number

events

After 26 weeks and 52 weeks of treatment

ID	Title	Description
OG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
OG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Secondary

Number of Hypoglycaemic Episodes

Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 - 07:00] and over the entire day (24 hours)

Safety analysis set included all subjects receiving at least one dose of investigational product.

Posted

Number

episodes

After 26 weeks and 52 weeks of treatment

ID	Title	Description
OG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
OG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Secondary

Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))

Episodes of PG >11.1mmol/L (200mg/dL)

Safety analysis set included all subjects receiving at least one dose of investigational product.

Posted

Number

episodes

After 26 weeks and 52 weeks of treatment

ID	Title	Description
OG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
OG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Secondary

Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))

Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment

Full Analysis Set (FAS) Included all randomised subjects

Posted

Number

episodes

After 26 weeks and 52 weeks of treatment

ID	Title	Description
OG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
OG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Secondary

Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment

Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.

Full Analysis Set (FAS) Included all randomised subjects. 1 subject was excluded from the analysis in the IDet arm as he was withdrawn before exposure to trial drug.

Posted

Mean

Standard Deviation

pmol/L

Between week 1 and week 26

ID	Title	Description
OG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
OG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Secondary

Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)

Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)

Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.

Posted

Mean

Standard Deviation

%B/T

After 52 weeks of treatment

ID	Title	Description
OG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
OG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Faecaloma	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected174 at risk EG0011 events1 affected175 at risk
Appendicitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0012 events2 affected175 at risk
Bronchitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Gastroenteritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0012 events2 affected175 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected174 at risk EG0012 events2 affected175 at risk
Pharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected174 at risk EG0011 events1 affected175 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Blood ketone body increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0002 events1 affected174 at risk EG0014 events2 affected175 at risk
Body temperature increased	Investigations	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected174 at risk EG0011 events1 affected175 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0007 events5 affected174 at risk EG0012 events2 affected175 at risk
Ketosis	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0011 events1 affected175 at risk
Convulsion	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected175 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0014 events3 affected175 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 events1 affected174 at risk EG0011 events1 affected175 at risk
Loss of consciousness	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected174 at risk EG0011 events1 affected175 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected174 at risk EG0011 events1 affected175 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 events0 affected174 at risk EG0011 events1 affected175 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear pain	Ear and labyrinth disorders	MedDRA 16.0	Systematic Assessment	EG00012 events10 affected174 at risk EG0015 events5 affected175 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00016 events12 affected174 at risk EG00112 events8 affected175 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00042 events28 affected174 at risk EG00130 events17 affected175 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00026 events22 affected174 at risk EG00125 events17 affected175 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00018 events13 affected174 at risk EG00112 events9 affected175 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG00038 events26 affected174 at risk EG00135 events22 affected175 at risk
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG00059 events30 affected174 at risk EG00145 events28 affected175 at risk
Bronchitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00010 events9 affected174 at risk EG00111 events8 affected175 at risk
Ear infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00011 events9 affected174 at risk EG00111 events11 affected175 at risk
Gastroenteritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00019 events15 affected174 at risk EG00125 events22 affected175 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00015 events10 affected174 at risk EG00113 events8 affected175 at risk
Influenza	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00019 events16 affected174 at risk EG00121 events18 affected175 at risk
Nasopharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG000177 events72 affected174 at risk EG001141 events67 affected175 at risk
Pharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0007 events6 affected174 at risk EG00113 events9 affected175 at risk
Rhinitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00019 events12 affected174 at risk EG00123 events14 affected175 at risk
Sinusitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00013 events9 affected174 at risk EG0016 events6 affected175 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG00056 events34 affected174 at risk EG00158 events24 affected175 at risk
Viral infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0008 events6 affected174 at risk EG00118 events10 affected175 at risk
Blood ketone body increased	Investigations	MedDRA 16.0	Systematic Assessment	EG00078 events31 affected174 at risk EG001131 events46 affected175 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG00062 events26 affected174 at risk EG00131 events17 affected175 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG00016 events11 affected174 at risk EG0015 events5 affected175 at risk
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG000106 events46 affected174 at risk EG001121 events51 affected175 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG00052 events31 affected174 at risk EG00141 events28 affected175 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG00017 events13 affected174 at risk EG00113 events7 affected175 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG00045 events29 affected174 at risk EG00150 events34 affected175 at risk

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

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
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

ID	Title	Description
BG000	IDeg + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
BG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
BG002	Total	Total of all reporting 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 + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.			18	174	146	174
EG001	IDet + IAsp	Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.			16	175	143	175

ID	Term
C571886	insulin degludec
D000069057	Insulin Detemir
D061267	Insulin Aspart