Comparison of Insulin Detemir, Insulin Aspart and Biphasi... | NCT00184600

ID	Type	Description	Link
2004-000514-38	EudraCT Number

Label	Type	Description	Intervention Names
Insulin detemir (basal insulin)	Experimental	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen.	Drug: insulin detemir
Insulin aspart (prandial insulin)	Active Comparator	Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen.	Drug: biphasic insulin aspart
Biphasic insulin aspart 30 (biphasic insulin)	Active Comparator	Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen.

Name	Type	Description	Arm Group Labels	Other Names
biphasic insulin aspart	Drug	Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart	Insulin aspart (prandial insulin)

Measure	Description	Time Frame
HbA1c (Glycosylated Haemoglobin) at Month 12	HbA1c values offer evidence of the efficacy and durability of the insulin regimens.	Baseline, Month 12
HbA1c (Glycosylated Haemoglobin) at Month 36	HbA1c values offer evidence of the efficacy and durability of the insulin regimens.	Baseline, Month 36

Measure	Description	Time Frame
Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%	Two participant counts are listed. The first is the percentage of total participants who achieved the target (HbA1c below or equal to 6.5%) at Month 12. The second is the percentage of subset of participants who achieved the target and did not have either minor or major hypoglycaemic episode within the four weeks prior to the month 12 exam. Minor hypoglycaemic episode is an episode in which the participant was able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major hypoglycaemic episode is an episode in which the participant was unable to treat her/himself.

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		Dublin		DUBLIN 15	Ireland
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
19850703	Result	Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF, Paul SK; 4-T Study Group. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009 Oct 29;361(18):1736-47. doi: 10.1056/NEJMoa0905479. Epub 2009 Oct 22.
17890232	Result	Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC; 4-T Study Group. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007 Oct 25;357(17):1716-30. doi: 10.1056/NEJMoa075392. Epub 2007 Sep 21.

Label	URL
Clinical Trials at Novo Nordisk	View source

ID	Title	Description
FG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen

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

HbA1c (Glycosylated Haemoglobin) at Month 12

HbA1c values offer evidence of the efficacy and durability of the insulin regimens.

Intention to treat analyses (ITT) included all those randomised. Missing data was imputed by SAS Proc MI (Multiple Imputation), using the non-parametric Propensity Score method for data with monotone missing pattern under the assumption of non-normality and the Bayesian Monte Carlo Markov Chain approach for data with values missing intermittently.

Posted

Mean

Standard Deviation

percentage (%) of total haemoglobin

Baseline, Month 12

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
OG001	Insulin Aspart (Prandial Insulin)	Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
OG002	Biphasic Insulin Aspart 30 (Biphasic Insulin)	Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen

Units	Counts
Participants	OG000234 OG001239 OG002235

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0008.45± 0.80 OG0018.55± 0.78 OG0028.63± 0.81

Month 12

Primary

HbA1c (Glycosylated Haemoglobin) at Month 36

HbA1c values offer evidence of the efficacy and durability of the insulin regimens.

Posted

Mean

Standard Deviation

percentage (%) of total haemoglobin

Baseline, Month 36

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
OG001

Secondary

Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%

Two participant counts are listed. The first is the percentage of total participants who achieved the target (HbA1c below or equal to 6.5%) at Month 12. The second is the percentage of subset of participants who achieved the target and did not have either minor or major hypoglycaemic episode within the four weeks prior to the month 12 exam. Minor hypoglycaemic episode is an episode in which the participant was able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major hypoglycaemic episode is an episode in which the participant was unable to treat her/himself.

Posted

Number

percentage of participants

Month 12

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen

Secondary

Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%

Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36

Posted

Number

percentage of participants

Month 36

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
OG001

Secondary

Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%

Rate of hypoglycaemic events was calculated as the median number of events per participant per year, defined as grade 1 (symptoms only), 2 (minor) and 3 (major). Symptoms only if self-measured plasma glucose level of 3.1 mmol/L (56 mg/dL) or more. Minor (grade 2) if able to treat her/himself and plasma glucose was below 3.1 mmol/L (56 mg/dL). Major (grade 3) if unable to treat her/himself. Rates are reported for all participants and for the subset of participants who achieved target HbA1c below or equal to 6.5%.

Posted

Median

Inter-Quartile Range

hypoglycaemic events/participant/year

Month 12

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen

Secondary

Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%

Posted

Median

Inter-Quartile Range

hypoglycaemic events/participant/year

Month 36

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen

Secondary

Percentage of Participants Who Required A Second Insulin Therapy by Month 12

Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.

Posted

Number

percentage of participants

Month 12

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen

Secondary

Percentage of Participants Who Required A Second Insulin Therapy by Month 36

Percentage of participants who required a second insulin formulation to be added to their treatment. This outcome offers evidence to the efficacy and durability of the insulin regimens.

Posted

Number

percentage of participants

Month 36

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen

Secondary

Change From Baseline in Body Weight at Month 12

Posted

Mean

Standard Deviation

kilogram

Week 0 (baseline), month 12

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
OG001	Insulin Aspart (Prandial Insulin)

Secondary

Change From Baseline in Body Weight at Month 36

Posted

Mean

Standard Deviation

kilograms

Week 0 (baseline), month 36

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
OG001	Insulin Aspart (Prandial Insulin)

Secondary

Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months

For each visit and telephone contact, participants were asked to perform in advance three capillary glucose profiles (using blood glucose metre provided for the trial) obtained before breakfast and before the evening meal for participants in the biphasic and basal groups and before meals and two hours after meals and at bedtime in the prandial group.

Posted

Mean

Standard Deviation

mg/dL

Baseline, month 12

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen

Secondary

Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months

Posted

Mean

Standard Deviation

mg/dL

Baseline, month 36

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen

Secondary

Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months

The EuroQol Group 5-Dimension Self-Report Questionnaire score (EQ5D) is a standardised instrument for use as a measure of health outcome in medical research. Responses can be used to generate a single numerical value associated with a given health state. The scale of values is graded from -0.59 to 1.00, with lower scores indicating a poorer health status. A score of 0 represents no quality of life and scores less than 0 represent states perceived by the respondent to be worse than death.

Posted

Mean

95% Confidence Interval

units on a scale

Month 12

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen

Secondary

Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months

Posted

Mean

95% Confidence Interval

units on a scale

Month 36

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen

Secondary

Number of Participants Having an 'Other' Adverse Event

Safety population consisting of all randomised participants exposed to at least one dose of trial drug(s).

Posted

Number

participants

Up to month 37 (36 months of treatment plus 1 month follow-up)

ID	Title	Description
OG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
OG001	Insulin Aspart (Prandial Insulin)	Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal abscess	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0002 events1 affected234 at risk EG0011 events1 affected239 at risk EG0025 events5 affected235 at risk
Abscess limb	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0003 events3 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0002 events2 affected234 at risk EG0011 events1 affected239 at risk EG0022 events2 affected235 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Adverse drug reaction	General disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Alcoholic liver disease	Hepatobiliary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events1 affected235 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Anal abscess	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0002 events2 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Anal fissure	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Angina pectoris	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0005 events4 affected234 at risk EG0014 events2 affected239 at risk EG00211 events8 affected235 at risk
Angina unstable	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0003 events3 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Anxiety	Psychiatric disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Anxiety disorder	Psychiatric disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Arterial stenosis limb	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Ascites	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events2 affected235 at risk
Asthenia	General disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0003 events2 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Atrial fibrillation	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0002 events1 affected234 at risk EG0011 events1 affected239 at risk EG0022 events1 affected235 at risk
Atrial flutter	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events1 affected235 at risk
Atrioventricular block	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events2 affected235 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Biliary sepsis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Biopsy liver	Investigations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Borderline ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Bradycardia	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0002 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Bronchiectasis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0022 events2 affected235 at risk
Bronchitis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Bronchpulmonary aspergillosis allergic	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events2 affected235 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Cardiac arrest	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Cardiac failure	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0015 events3 affected239 at risk EG0022 events2 affected235 at risk
Cardiac failure acute	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0003 events3 affected234 at risk EG0011 events1 affected239 at risk EG0025 events4 affected235 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0023 events3 affected235 at risk
Cataract	Eye disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Catheterisation cardiac	Investigations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Cellulitis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0026 events6 affected235 at risk
Cellulitis orbital	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Cerebral infarction	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0002 events2 affected234 at risk EG0010 events0 affected239 at risk EG0023 events3 affected235 at risk
Change of bowel habit	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Chest discomfort	General disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events2 affected235 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Chest pain	General disorders	MedDRA Unspecified	Systematic Assessment	EG0005 events5 affected234 at risk EG0016 events1 affected239 at risk EG0023 events3 affected235 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0012 events2 affected239 at risk EG0021 events1 affected235 at risk
Circulatory collapse	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0014 events4 affected239 at risk EG0020 events0 affected235 at risk
Clostridial infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Coeliac disease	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Cognitive disorder	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Colitis	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Colon cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Confusional state	Psychiatric disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Constipation	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Coronary artery disease	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0022 events2 affected235 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Deep vein thrombosis	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Depression	Psychiatric disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Diabetic retinopathy	Eye disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0012 events2 affected239 at risk EG0022 events2 affected235 at risk
Dislocation of joint prosthesis	General disorders	MedDRA Unspecified	Systematic Assessment	EG0002 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Diverticulitis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
Diverticulum	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0013 events2 affected239 at risk EG0021 events1 affected235 at risk
Dizziness	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Drug dispensing error	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Dupuytren's contracture operation	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0003 events3 affected234 at risk EG0013 events3 affected239 at risk EG0023 events3 affected235 at risk
Dysuria	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Endometrial cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events2 affected235 at risk
Eyelid ptosis	Eye disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0022 events2 affected235 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Femoral artery occlusion	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0023 events3 affected235 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Food poisoning	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Gait disturbance	General disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Galbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Gangrene	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events2 affected235 at risk
Gastritis	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Gastroenteritis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0002 events2 affected234 at risk EG0010 events0 affected239 at risk EG0024 events4 affected235 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Goitre	Endocrine disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Graft infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Haematemesis	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0022 events2 affected235 at risk
Haematochezia	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Haematoma	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Haematospermia	Reproductive system and breast disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Haematuria	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0021 events1 affected235 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Hepatic neoplasm malignant recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Unspecified	Systematic Assessment	EG0007 events5 affected234 at risk EG00113 events13 affected239 at risk EG00214 events12 affected235 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Hypoglycaemic unconsciousness	Metabolism and nutrition disorders	MedDRA Unspecified	Systematic Assessment	EG0003 events3 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Hypotension	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Infected skin ulcer	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Infective exacerbation of chronic obstructive airways	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Intermittent claudication	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0002 events2 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
International normalised ratio increased	Investigations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0024 events4 affected235 at risk
Ischaemia	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Labyrinthitis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Lacunar infarction	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Left ventribular dysfunction	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Left ventricular failure	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0002 events2 affected234 at risk EG0011 events1 affected239 at risk EG0022 events2 affected235 at risk
Leiomyosarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Lichen sclerosus	Skin and subcutaneous tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0024 events1 affected235 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Lobar pneumonia	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Localised infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Loss of consciousness	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Lower extremity mass	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0023 events3 affected235 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Medication error	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Melaena	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Multi-organ failure	General disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events2 affected235 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Myocardial infarction	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0006 events6 affected234 at risk EG0014 events4 affected239 at risk EG0022 events2 affected235 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0014 events4 affected239 at risk EG0022 events2 affected235 at risk
Nail infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Nausea	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Non-cardiac chest pain	General disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Non-small cell lung cancer stage IIIB	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Oedema peripheral	General disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events1 affected235 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0004 events4 affected234 at risk EG0011 events1 affected239 at risk EG0027 events6 affected235 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Palpitations	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0022 events2 affected235 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Pancreatolithiasis	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Panic attack	Psychiatric disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Paraesthesia	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Penile prosthesis insertion	Surgical and medical procedures	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Perineal abscess	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0013 events1 affected239 at risk EG0020 events0 affected235 at risk
Pernicious anaemia	Blood and lymphatic system disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Pilonidal cyst	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Pneumocephalus	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Pneumonia	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0022 events2 affected235 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Postoperative wound infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Presyncope	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0021 events1 affected235 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0003 events3 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
Pulse absent	Investigations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Pyelonephritis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
Pyrexia	General disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Radiculitis brachial	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Rectal cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0002 events2 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Renal colic	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0022 events2 affected235 at risk
Renal failure	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
Renal failure acute	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events1 affected239 at risk EG0020 events0 affected235 at risk
Renal impairment	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0022 events2 affected235 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events2 affected235 at risk
Respiratory tract infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Retinal detachment	Eye disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Right ventricular failure	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Scrotal abscess	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Sensory loss	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Sepsis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0002 events2 affected234 at risk EG0010 events0 affected239 at risk EG0022 events2 affected235 at risk
Sinus bradycardia	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0002 events2 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Skull fracture base	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Smear cervix abnormal	Investigations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Spinal cord compression	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Staphylococcal osteomyelitis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Stent related infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0022 events1 affected235 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0022 events2 affected235 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Umbilical hernia repair	Surgical and medical procedures	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Urethral meatus stenosis	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Urinary retention	Renal and urinary disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0022 events2 affected235 at risk
Urinary tract infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0011 events1 affected239 at risk EG0023 events3 affected235 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Varicose vein	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Vasculitis	Vascular disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Vision blurred	Eye disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Vomiting	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk
Wegener's granulomatosis	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG0001 events1 affected234 at risk EG0010 events0 affected239 at risk EG0020 events0 affected235 at risk
Wound infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0012 events2 affected239 at risk EG0020 events0 affected235 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0000 events0 affected234 at risk EG0010 events0 affected239 at risk EG0021 events1 affected235 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG0002 events2 affected234 at risk EG0011 events1 affected239 at risk EG0020 events0 affected235 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal discomfort	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG00033 events14 affected234 at risk EG00124 events16 affected239 at risk EG00240 events27 affected235 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG00012 events9 affected234 at risk EG0017 events7 affected239 at risk EG00220 events14 affected235 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Unspecified	Systematic Assessment	EG00019 events19 affected234 at risk EG00114 events13 affected239 at risk EG00216 events14 affected235 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG00016 events15 affected234 at risk EG00132 events23 affected239 at risk EG00232 events25 affected235 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG00040 events31 affected234 at risk EG00142 events38 affected239 at risk EG00235 events28 affected235 at risk
Bronchitis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG00017 events12 affected234 at risk EG00113 events10 affected239 at risk EG00217 events6 affected235 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG00066 events48 affected234 at risk EG00163 events51 affected239 at risk EG00246 events38 affected235 at risk
Depression	Psychiatric disorders	MedDRA Unspecified	Systematic Assessment	EG00010 events8 affected234 at risk EG00112 events12 affected239 at risk EG00216 events16 affected235 at risk
Diabetic retinopathy	Eye disorders	MedDRA Unspecified	Systematic Assessment	EG00020 events19 affected234 at risk EG00110 events10 affected239 at risk EG0024 events4 affected235 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG000115 events60 affected234 at risk EG00175 events53 affected239 at risk EG00263 events45 affected235 at risk
Dizziness	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG00028 events20 affected234 at risk EG00123 events16 affected239 at risk EG00217 events15 affected235 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG00038 events21 affected234 at risk EG00115 events14 affected239 at risk EG00219 events13 affected235 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG00015 events13 affected234 at risk EG00124 events20 affected239 at risk EG00214 events13 affected235 at risk
Ear infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG0008 events6 affected234 at risk EG00115 events11 affected239 at risk EG00217 events17 affected235 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Unspecified	Systematic Assessment	EG00024 events20 affected234 at risk EG00123 events20 affected239 at risk EG00220 events16 affected235 at risk
Fatigue	General disorders	MedDRA Unspecified	Systematic Assessment	EG00015 events12 affected234 at risk EG00112 events10 affected239 at risk EG0027 events4 affected235 at risk
Gastroenteritis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG00013 events10 affected234 at risk EG00112 events8 affected239 at risk EG00215 events14 affected235 at risk
Infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG00084 events50 affected234 at risk EG00188 events55 affected239 at risk EG00289 events59 affected235 at risk
Influenza	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG00055 events37 affected234 at risk EG00133 events29 affected239 at risk EG00243 events33 affected235 at risk
Injection site haematoma	General disorders	MedDRA Unspecified	Systematic Assessment	EG00049 events39 affected234 at risk EG00150 events34 affected239 at risk EG00246 events34 affected235 at risk
Injection site mass	General disorders	MedDRA Unspecified	Systematic Assessment	EG00023 events18 affected234 at risk EG0017 events7 affected239 at risk EG00221 events16 affected235 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG00015 events14 affected234 at risk EG00114 events14 affected239 at risk EG0028 events8 affected235 at risk
Localised infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG00013 events9 affected234 at risk EG00114 events12 affected239 at risk EG00220 events16 affected235 at risk
Malaise	General disorders	MedDRA Unspecified	Systematic Assessment	EG00038 events15 affected234 at risk EG00138 events18 affected239 at risk EG00227 events18 affected235 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG00014 events11 affected234 at risk EG00115 events13 affected239 at risk EG00211 events7 affected235 at risk
Nasopharyngitis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG000251 events108 affected234 at risk EG001211 events97 affected239 at risk EG002208 events99 affected235 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Unspecified	Systematic Assessment	EG00051 events35 affected234 at risk EG00155 events31 affected239 at risk EG00237 events27 affected235 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Unspecified	Systematic Assessment	EG00037 events30 affected234 at risk EG00135 events31 affected239 at risk EG00241 events36 affected235 at risk
Paraesthesia	Nervous system disorders	MedDRA Unspecified	Systematic Assessment	EG00013 events13 affected234 at risk EG00116 events11 affected239 at risk EG00218 events13 affected235 at risk
Pharyngitis	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG00017 events13 affected234 at risk EG0018 events8 affected239 at risk EG0029 events7 affected235 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Unspecified	Systematic Assessment	EG00014 events11 affected234 at risk EG00112 events12 affected239 at risk EG00214 events14 affected235 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG00051 events33 affected234 at risk EG00151 events28 affected239 at risk EG00235 events27 affected235 at risk
Urinary tract infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG00067 events32 affected234 at risk EG00131 events24 affected239 at risk EG00260 events30 affected235 at risk
Viral infection	Infections and infestations	MedDRA Unspecified	Systematic Assessment	EG00012 events12 affected234 at risk EG00113 events10 affected239 at risk EG00217 events13 affected235 at risk
Vomiting	Gastrointestinal disorders	MedDRA Unspecified	Systematic Assessment	EG00080 events45 affected234 at risk EG00168 events44 affected239 at risk EG00271 events43 affected235 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
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	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
BG001	Insulin Aspart (Prandial Insulin)	Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
BG002	Biphasic Insulin Aspart 30 (Biphasic Insulin)	Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Insulin Detemir (Basal Insulin)	Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen	78	234	227	234
EG001	Insulin Aspart (Prandial Insulin)	Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen	79	239	235	239
EG002	Biphasic Insulin Aspart 30 (Biphasic Insulin)	Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen	105	235	228	235

ID	Term
C557564	insulin aspart, insulin aspart protamine drug combination 30:70
D000069057	Insulin Detemir
D061267	Insulin Aspart