Comparison of Two NN5401 Formulations Versus Insulin Glar... | NCT00614055

NCT00614055

ID	Type	Description	Link
2007-002476-33	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	Intervention Names
Insulin glargine	Active Comparator	Drug: insulin glargine Drug: metformin
SIAC 30 (B)	Experimental	Drug: insulin degludec/insulin aspart Drug: metformin
SIAC 45 (B)	Experimental	Drug: insulin degludec/insulin aspart Drug: metformin

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec/insulin aspart	Drug	Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily	SIAC 30 (B)

Outcomes Module

Measure	Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c)	Change from baseline in HbA1c after 16 weeks of treatment	Week 0, Week 16

Secondary Outcomes

Measure	Description	Time Frame
Change in Fasting Plasma Glucose (FPG)	Change from baseline in FPG after 16 weeks of treatment	Week 0, Week 16
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)	Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.

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		Alès		30100	France
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21285389	Result	Heise T, Tack CJ, Cuddihy R, Davidson J, Gouet D, Liebl A, Romero E, Mersebach H, Dykiel P, Jorde R. A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial. Diabetes Care. 2011 Mar;34(3):669-74. doi: 10.2337/dc10-1905. Epub 2011 Feb 1.
22946603

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	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

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

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
BG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
BG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
BG003	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
	BG00058.7± 8.8 BG00160.2± 8.4 BG00258.4± 8.4 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00022 BG00125 BG002

Glycosylated haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.3± 1.2 BG0018.6± 1.5 BG002

Fasting plasma glucose (FPG)

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG00011.1± 3.3 BG00111.5± 3.2 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 16 weeks of treatment

Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 16

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Units	Counts
Participants	OG00059 OG00159 OG00260

Title

Denominators

Categories

Title	Measurements
	OG000-1.31± 1.01 OG001-1.46± 1.39 OG002-1.29± 1.10

Secondary

Change in Fasting Plasma Glucose (FPG)

Change from baseline in FPG after 16 weeks of treatment

The FAS included all randomised subjects and missing data was imputed using LOCF.

Posted

Mean

Standard Deviation

mmol/L

Week 0, Week 16

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Secondary

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.

The FAS included all randomised subjects and missing data was imputed using LOCF.

Posted

Mean

Standard Error

mmol/L

Week 16

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine

Secondary

Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Events/100 years of patient exposure

Week 0 to Week 16 + 5 days follow up

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Secondary

Rate of Major and Minor Hypoglycaemic Episodes

Rate of Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.

The FAS included all randomised subjects.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 16 + 5 days follow up

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Secondary

Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

Rate of nocturnal Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).

The FAS included all randomised subjects.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 16 + 5 days follow up

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine

Secondary

Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)

Values at screening (Week -4) and at Week 16

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Mean

Standard Deviation

IU/L

Week -4, Week 16

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Secondary

Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)

Values at screening (Week -4) and at Week 16

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Mean

Standard Deviation

IU/L

Week -4, Week 16

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Secondary

Laboratory Safety Parameters (Biochemistry): Serum Creatinine

Values at screening (Week -4) and at Week 16

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Mean

Standard Deviation

umol/L

Week -4, Week 16

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Secondary

Vital Signs: Diastolic Blood Pressure (BP)

Values at baseline (Week 0) and at Week 16

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Mean

Standard Deviation

mmHg

Week 0, Week 16

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Secondary

Vital Signs: Systolic Blood Pressure (BP)

Values at baseline (Week 0) and at Week 16

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Mean

Standard Deviation

mmHg

Week 0, Week 16

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Secondary

Vital Signs: Pulse

Values at baseline (Week 0) and at Week 16

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Mean

Standard Deviation

beats/minute

Week 0, Week 16

ID	Title	Description
OG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Secondary

Physical Examination

Physical examination is performed at baseline (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.

Posted

Week 0, Week 8, Week 16

ID	Title	Description
OG000	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG001	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
OG002	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SIAC 30 (B)	Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.	2	59	23	59
EG001	SIAC 45 (B)	Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.	1	59	16	59
EG002	Insulin Glargine	Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.	0	60	13	60

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Transient ischaemic attack	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected59 at risk EG0020 events0 affected60 at risk
Depression	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0010 events0 affected59 at risk EG0020 events0 affected60 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0011 events1 affected59 at risk EG0020 events0 affected60 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dyspepsia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 events3 affected59 at risk EG0012 events2 affected59 at risk EG0021 events1 affected60 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected59 at risk EG0013 events3 affected59 at risk EG0020 events0 affected60 at risk
Influenza	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 events0 affected59 at risk EG0012 events2 affected59 at risk EG0023 events3 affected60 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected59 at risk EG0013 events3 affected59 at risk EG0023 events1 affected60 at risk
C-reactive protein increased	Investigations	MedDRA 11.1	Systematic Assessment	EG00014 events14 affected59 at risk EG0015 events5 affected59 at risk EG0029 events9 affected60 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected59 at risk EG0014 events4 affected59 at risk EG0026 events6 affected60 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

ID	Term
C578220	insulin degludec, insulin aspart drug combination
D000069036	Insulin Glargine
D008687	Metformin

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
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases