Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
58 sites across the United Kingdom and Ireland. Recruitment period: November 2004-August 2006

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects continued their current oral anti-diabetic drug (OAD) treatment (metformin and/or sulphonylurea) without changing the dose throughout the trial. Subjects were asked not to alter their current diet and activities throughout the trial unless clinically necessary. Subjects fasted from 22:00 the evening prior to randomisation.

Reporting Groups

	Description
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
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
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

Participant Flow:   Overall Study

	Insulin Detemir (Basal Insulin)	Insulin Aspart (Prandial Insulin)	Biphasic Insulin Aspart 30 (Biphasic Insulin)
STARTED	234	239	235
COMPLETED	189	188	201
NOT COMPLETED	45	51	34
Adverse Event	9	0	5
Death	3	9	7
Lack of Efficacy	3	1	3
Lost to Follow-up	4	6	1
Protocol Violation	2	2	3
Withdrawal by Subject	20	28	12
Unclassified	4	5	3

Reporting Groups

	Description
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
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
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

Baseline Measures

	Insulin Detemir (Basal Insulin)	Insulin Aspart (Prandial Insulin)	Biphasic Insulin Aspart 30 (Biphasic Insulin)	Total
Number of Participants   [units: participants]	234	239	235	708
Age   [units: years] Mean ± Standard Deviation	61.87  ± 9.97	61.60  ± 10.54	61.67  ± 8.93	61.7  ± 9.8
Gender   [units: participants]
Female	91	87	76	254
Male	143	152	159	454
Race/Ethnicity, Customized   [units: participants]
White	218	214	221	653
Mixed	2	4	1	7
Asian / Asian British	9	15	11	35
Black / Black British	2	5	2	9
Other	3	1	0	4
Smoking [1] [units: participants]
Non Smoker, Never Smoked	106	88	82	276
Ex Smoker	95	108	120	323
Current Smoker	33	43	33	109
Oral Anti-Diabetic Drugs (OADs) [2] [units: participants]
Metformin	2	0	4	6
Sulphonylurea	8	12	10	30
Metformin + Sulphonylurea	224	227	221	672
Diabetic complication, Retinopathy [3] [units: participants]
Yes	43	45	34	122
No	191	194	201	586
Diabetic complication, Neuropathy [3] [units: participants]
Yes	39	55	41	135
No	195	184	194	573
Diabetic complication, Nephropathy [3] [units: participants]
Yes	23	24	21	68
No	211	215	214	640
Diabetic complication, Macroaniopathy [3] [units: participants]
Yes	44	42	52	138
No	190	197	183	570
Duration of diabetes [4] [units: years] Median ( Inter-Quartile Range )	9     ( 6 to 12 )	9     ( 6 to 14 )	9     ( 6 to 12 )	9     ( 6 to 13 )
Alcohol [5] [units: units] Median ( Inter-Quartile Range )	4     ( 2 to 12 )	5     ( 2 to 12 )	6     ( 2 to 12 )	5     ( 2 to 12 )
Weight [6] [units: kg] Mean ± Standard Deviation	85.52  ± 16.25	84.92  ± 14.43	86.91  ± 16.82	85.8  ± 15.9
Body Mass Index (BMI) [7] [units: kg/m^2] Mean ± Standard Deviation	29.82  ± 4.59	29.74  ± 4.51	30.34  ± 4.73	29.8  ± 4.6
Waist [8] [units: cm] Mean ± Standard Deviation
Men	104  ± 12	102  ± 11	104  ± 12	103  ± 12
Women	97  ± 12	100  ± 11	98  ± 13	98  ± 12
Eight-point Capillary Plasma Glucose Profiles   [units: mg/dL] Mean ± Standard Deviation
All time pointsexcluding 3 am	196  ± 43	200  ± 49	202  ± 47	200  ± 47
Fasting plasma	171  ± 47	173  ± 49	175  ± 50	173  ± 49
Postprandial	223  ± 50	227  ± 56	229  ± 54	227  ± 54
At 3 am	164  ± 56	164  ± 59	171  ± 58	166  ± 58

1.  Primary:

HbA1c (Glycosylated Haemoglobin) at Month 12   [ Time Frame: Baseline, Month 12 ]

2.  Primary:

HbA1c (Glycosylated Haemoglobin) at Month 36   [ Time Frame: Baseline, Month 36 ]

3.  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%   [ Time Frame: Month 12 ]

4.  Secondary:

Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%   [ Time Frame: Month 36 ]

5.  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%   [ Time Frame: Month 12 ]

6.  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%   [ Time Frame: Month 36 ]

7.  Secondary:

Percentage of Participants Who Required A Second Insulin Therapy by Month 12   [ Time Frame: Month 12 ]

8.  Secondary:

Percentage of Participants Who Required A Second Insulin Therapy by Month 36   [ Time Frame: Month 36 ]

9.  Secondary:

Change From Baseline in Body Weight at Month 12   [ Time Frame: Week 0 (baseline), month 12 ]

10.  Secondary:

Change From Baseline in Body Weight at Month 36   [ Time Frame: Week 0 (baseline), month 36 ]

11.  Secondary:

Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months   [ Time Frame: Baseline, month 12 ]

12.  Secondary:

Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months   [ Time Frame: Baseline, month 36 ]

13.  Secondary:

Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months   [ Time Frame: Month 12 ]

14.  Secondary:

Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months   [ Time Frame: Month 36 ]

15.  Secondary:

Number of Participants Having an 'Other' Adverse Event   [ Time Frame: Up to month 37 (36 months of treatment plus 1 month follow-up) ]