Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).
Interventions
DRUGbiphasic insulin aspart
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
DRUGinsulin detemir
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
DRUGinsulin aspart
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Insulin naive * On OAD treatment for at least 4 months with metformin, a sulphonylurea or a combination * Body Mass Index (BMI) below or equal to 40.0 kg/m2 * HbA1c (glycosylated haemoglobin): 7.0%-10% (both inclusive)
Exclusion criteria
* Proliferative retinopathy * Recurrent major hypoglycaemia * Cardial problems * Uncontrolled hypertension * Impaired hepatic or renal function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c (Glycosylated Haemoglobin) at Month 12 | Baseline, Month 12 | HbA1c values offer evidence of the efficacy and durability of the insulin regimens. |
| HbA1c (Glycosylated Haemoglobin) at Month 36 | Baseline, Month 36 | HbA1c values offer evidence of the efficacy and durability of the insulin regimens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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% | Month 12 | 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%. |
| 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% | Month 36 | 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%. |
| Percentage of Participants Who Required A Second Insulin Therapy by Month 12 | 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. |
| Percentage of Participants Who Required A Second Insulin Therapy by Month 36 | 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. |
| Change From Baseline in Body Weight at Month 12 | Week 0 (baseline), month 12 | — |
| 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% | Month 12 | 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. |
| Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | Baseline, month 12 | 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. |
| Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | Baseline, month 36 | 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. |
| Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months | Month 12 | 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. |
| Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months | Month 36 | 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. |
| Number of Participants Having an 'Other' Adverse Event | Up to month 37 (36 months of treatment plus 1 month follow-up) | — |
| Change From Baseline in Body Weight at Month 36 | Week 0 (baseline), month 36 | — |
| Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5% | Month 36 | Percentage of participants who achieved the target (HbA1c below or equal to 6.5%) at Month 36 |
Countries
Ireland, United Kingdom
Participant flow
Recruitment details
58 sites across the United Kingdom and Ireland. Recruitment period: November 2004-August 2006
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 234 |
| 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 | 239 |
| 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 | 235 |
| Total | 708 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 0 | 5 |
| Overall Study | Death | 3 | 9 | 7 |
| Overall Study | Lack of Efficacy | 3 | 1 | 3 |
| Overall Study | Lost to Follow-up | 4 | 6 | 1 |
| Overall Study | Protocol Violation | 2 | 2 | 3 |
| Overall Study | Unclassified | 4 | 5 | 3 |
| Overall Study | Withdrawal by Subject | 20 | 28 | 12 |
Baseline characteristics
| Characteristic | Insulin Detemir (Basal Insulin) | Insulin Aspart (Prandial Insulin) | Biphasic Insulin Aspart 30 (Biphasic Insulin) | Total |
|---|---|---|---|---|
| Age, Continuous | 61.87 years STANDARD_DEVIATION 9.97 | 61.60 years STANDARD_DEVIATION 10.54 | 61.67 years STANDARD_DEVIATION 8.93 | 61.7 years STANDARD_DEVIATION 9.8 |
| Alcohol | 4 units INTER_QUARTILE_RANGE 9.16 | 5 units INTER_QUARTILE_RANGE 7.88 | 6 units INTER_QUARTILE_RANGE 9.61 | 5 units |
| Body Mass Index (BMI) | 29.82 kg/m^2 STANDARD_DEVIATION 4.59 | 29.74 kg/m^2 STANDARD_DEVIATION 4.51 | 30.34 kg/m^2 STANDARD_DEVIATION 4.73 | 29.8 kg/m^2 STANDARD_DEVIATION 4.6 |
| Diabetic complication, Macroaniopathy No | 190 participants | 197 participants | 183 participants | 570 participants |
| Diabetic complication, Macroaniopathy Yes | 44 participants | 42 participants | 52 participants | 138 participants |
| Diabetic complication, Nephropathy No | 211 participants | 215 participants | 214 participants | 640 participants |
| Diabetic complication, Nephropathy Yes | 23 participants | 24 participants | 21 participants | 68 participants |
| Diabetic complication, Neuropathy No | 195 participants | 184 participants | 194 participants | 573 participants |
| Diabetic complication, Neuropathy Yes | 39 participants | 55 participants | 41 participants | 135 participants |
| Diabetic complication, Retinopathy No | 191 participants | 194 participants | 201 participants | 586 participants |
| Diabetic complication, Retinopathy Yes | 43 participants | 45 participants | 34 participants | 122 participants |
| Duration of diabetes | 9 years INTER_QUARTILE_RANGE 5.13 | 9 years INTER_QUARTILE_RANGE 5.54 | 9 years INTER_QUARTILE_RANGE 5.23 | 9 years |
| Eight-point Capillary Plasma Glucose Profiles All time pointsexcluding 3 am | 196 mg/dL STANDARD_DEVIATION 43 | 200 mg/dL STANDARD_DEVIATION 49 | 202 mg/dL STANDARD_DEVIATION 47 | 200 mg/dL STANDARD_DEVIATION 47 |
| Eight-point Capillary Plasma Glucose Profiles At 3 am | 164 mg/dL STANDARD_DEVIATION 56 | 164 mg/dL STANDARD_DEVIATION 59 | 171 mg/dL STANDARD_DEVIATION 58 | 166 mg/dL STANDARD_DEVIATION 58 |
| Eight-point Capillary Plasma Glucose Profiles Fasting plasma | 171 mg/dL STANDARD_DEVIATION 47 | 173 mg/dL STANDARD_DEVIATION 49 | 175 mg/dL STANDARD_DEVIATION 50 | 173 mg/dL STANDARD_DEVIATION 49 |
| Eight-point Capillary Plasma Glucose Profiles Postprandial | 223 mg/dL STANDARD_DEVIATION 50 | 227 mg/dL STANDARD_DEVIATION 56 | 229 mg/dL STANDARD_DEVIATION 54 | 227 mg/dL STANDARD_DEVIATION 54 |
| Oral Anti-Diabetic Drugs (OADs) Metformin | 2 participants | 0 participants | 4 participants | 6 participants |
| Oral Anti-Diabetic Drugs (OADs) Metformin + Sulphonylurea | 224 participants | 227 participants | 221 participants | 672 participants |
| Oral Anti-Diabetic Drugs (OADs) Sulphonylurea | 8 participants | 12 participants | 10 participants | 30 participants |
| Race/Ethnicity, Customized Asian / Asian British | 9 participants | 15 participants | 11 participants | 35 participants |
| Race/Ethnicity, Customized Black / Black British | 2 participants | 5 participants | 2 participants | 9 participants |
| Race/Ethnicity, Customized Mixed | 2 participants | 4 participants | 1 participants | 7 participants |
| Race/Ethnicity, Customized Other | 3 participants | 1 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized White | 218 participants | 214 participants | 221 participants | 653 participants |
| Sex: Female, Male Female | 91 Participants | 87 Participants | 76 Participants | 254 Participants |
| Sex: Female, Male Male | 143 Participants | 152 Participants | 159 Participants | 454 Participants |
| Smoking Current Smoker | 33 participants | 43 participants | 33 participants | 109 participants |
| Smoking Ex Smoker | 95 participants | 108 participants | 120 participants | 323 participants |
| Smoking Non Smoker, Never Smoked | 106 participants | 88 participants | 82 participants | 276 participants |
| Waist Men | 104 cm STANDARD_DEVIATION 12 | 102 cm STANDARD_DEVIATION 11 | 104 cm STANDARD_DEVIATION 12 | 103 cm STANDARD_DEVIATION 12 |
| Waist Women | 97 cm STANDARD_DEVIATION 12 | 100 cm STANDARD_DEVIATION 11 | 98 cm STANDARD_DEVIATION 13 | 98 cm STANDARD_DEVIATION 12 |
| Weight | 85.52 kg STANDARD_DEVIATION 16.25 | 84.92 kg STANDARD_DEVIATION 14.43 | 86.91 kg STANDARD_DEVIATION 16.82 | 85.8 kg STANDARD_DEVIATION 15.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 227 / 234 | 235 / 239 | 228 / 235 |
| serious Total, serious adverse events | 78 / 234 | 79 / 239 | 105 / 235 |
Outcome results
Primary
HbA1c (Glycosylated Haemoglobin) at Month 12
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Time frame: Baseline, Month 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir (Basal Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 12 | Baseline | 8.45 percentage (%) of total haemoglobin | Standard Deviation 0.8 |
| Insulin Detemir (Basal Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 12 | Month 12 | 7.64 percentage (%) of total haemoglobin | Standard Deviation 0.96 |
| Insulin Aspart (Prandial Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 12 | Baseline | 8.55 percentage (%) of total haemoglobin | Standard Deviation 0.78 |
| Insulin Aspart (Prandial Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 12 | Month 12 | 7.20 percentage (%) of total haemoglobin | Standard Deviation 1.06 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 12 | Baseline | 8.63 percentage (%) of total haemoglobin | Standard Deviation 0.81 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 12 | Month 12 | 7.33 percentage (%) of total haemoglobin | Standard Deviation 0.95 |
Primary
HbA1c (Glycosylated Haemoglobin) at Month 36
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Time frame: Baseline, Month 36
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir (Basal Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 36 | Baseline | 8.45 percentage (%) of total haemoglobin | Standard Deviation 0.8 |
| Insulin Detemir (Basal Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 36 | Month 36 | 7.11 percentage (%) of total haemoglobin | Standard Deviation 1.13 |
| Insulin Aspart (Prandial Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 36 | Baseline | 8.55 percentage (%) of total haemoglobin | Standard Deviation 0.78 |
| Insulin Aspart (Prandial Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 36 | Month 36 | 7.04 percentage (%) of total haemoglobin | Standard Deviation 1.17 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 36 | Baseline | 8.63 percentage (%) of total haemoglobin | Standard Deviation 0.81 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | HbA1c (Glycosylated Haemoglobin) at Month 36 | Month 36 | 7.22 percentage (%) of total haemoglobin | Standard Deviation 1.11 |
Secondary
Change From Baseline in Body Weight at Month 12
Time frame: Week 0 (baseline), month 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir (Basal Insulin) | Change From Baseline in Body Weight at Month 12 | 1.9 kilogram | Standard Deviation 4.2 |
| Insulin Aspart (Prandial Insulin) | Change From Baseline in Body Weight at Month 12 | 5.7 kilogram | Standard Deviation 4.6 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Change From Baseline in Body Weight at Month 12 | 4.7 kilogram | Standard Deviation 4 |
Secondary
Change From Baseline in Body Weight at Month 36
Time frame: Week 0 (baseline), month 36
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Detemir (Basal Insulin) | Change From Baseline in Body Weight at Month 36 | 3.6 kilograms | Standard Deviation 0.5 |
| Insulin Aspart (Prandial Insulin) | Change From Baseline in Body Weight at Month 36 | 6.4 kilograms | Standard Deviation 0.5 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Change From Baseline in Body Weight at Month 36 | 5.7 kilograms | Standard Deviation 0.5 |
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.
Time frame: Baseline, month 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir (Basal Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | All timepoints excluding 3am | -43 mg/dL | Standard Deviation 43 |
| Insulin Detemir (Basal Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | Fasting | -59 mg/dL | Standard Deviation 52 |
| Insulin Detemir (Basal Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | Postprandial | -47 mg/dL | Standard Deviation 54 |
| Insulin Detemir (Basal Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | 3am | -40 mg/dL | Standard Deviation 70 |
| Insulin Aspart (Prandial Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | 3am | -34 mg/dL | Standard Deviation 59 |
| Insulin Aspart (Prandial Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | All timepoints excluding 3am | -65 mg/dL | Standard Deviation 43 |
| Insulin Aspart (Prandial Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | Postprandial | -83 mg/dL | Standard Deviation 54 |
| Insulin Aspart (Prandial Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | Fasting | -23 mg/dL | Standard Deviation 49 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | 3am | -52 mg/dL | Standard Deviation 70 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | Fasting | -45 mg/dL | Standard Deviation 56 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | Postprandial | -68 mg/dL | Standard Deviation 63 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months | All timepoints excluding 3am | -59 mg/dL | Standard Deviation 54 |
Secondary
Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 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.
Time frame: Baseline, month 36
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Detemir (Basal Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | Postprandial | -67 mg/dL | Standard Deviation 50 |
| Insulin Detemir (Basal Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | All timepoints excluding 3am | -58 mg/dL | Standard Deviation 43 |
| Insulin Detemir (Basal Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | 3am | -45 mg/dL | Standard Deviation 77 |
| Insulin Detemir (Basal Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | Fasting | -47 mg/dL | Standard Deviation 49 |
| Insulin Aspart (Prandial Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | Postprandial | -85 mg/dL | Standard Deviation 59 |
| Insulin Aspart (Prandial Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | Fasting | -49 mg/dL | Standard Deviation 45 |
| Insulin Aspart (Prandial Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | 3am | -27 mg/dL | Standard Deviation 70 |
| Insulin Aspart (Prandial Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | All timepoints excluding 3am | -67 mg/dL | Standard Deviation 47 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | 3am | -38 mg/dL | Standard Deviation 77 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | All timepoints excluding 3am | -56 mg/dL | Standard Deviation 47 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | Fasting | -50 mg/dL | Standard Deviation 47 |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months | Postprandial | -61 mg/dL | Standard Deviation 58 |
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%.
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Insulin Detemir (Basal Insulin) | 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% | All participants, Grade 1 | 2.0 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | All participants, Grade 2 | 0 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | All participants, Grade 3 | 0 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | Achieved HbA1c target, Grade 2, n=18, 50, 39 | 3.0 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | Achieved HbA1c target, Grade 3, n=18, 50, 39 | 0 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | All participants, Grade 2 or 3 | 0 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | Achieved HbA1c target, Grade 1, n=18, 50, 39 | 3.9 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | Achieved HbA1c target, Grade 2 or 3, n=18, 50, 39 | 3.0 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | Achieved HbA1c target, Grade 2 or 3, n=18, 50, 39 | 8.7 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | All participants, Grade 1 | 8.0 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | Achieved HbA1c target, Grade 1, n=18, 50, 39 | 7.8 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | All participants, Grade 2 or 3 | 8.0 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | All participants, Grade 2 | 8.0 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | All participants, Grade 3 | 0 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | Achieved HbA1c target, Grade 3, n=18, 50, 39 | 0 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | Achieved HbA1c target, Grade 2, n=18, 50, 39 | 8.0 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | Achieved HbA1c target, Grade 3, n=18, 50, 39 | 0 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | Achieved HbA1c target, Grade 2, n=18, 50, 39 | 4.0 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | Achieved HbA1c target, Grade 2 or 3, n=18, 50, 39 | 4.0 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | All participants, Grade 2 | 3.9 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | Achieved HbA1c target, Grade 1, n=18, 50, 39 | 5.4 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | All participants, Grade 1 | 5.0 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | All participants, Grade 2 or 3 | 3.9 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | All participants, Grade 3 | 0 hypoglycaemic events/participant/year |
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%
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%.
Time frame: Month 36
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Insulin Detemir (Basal Insulin) | 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% | All participants, Grade 2 or 3 | 1.7 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | All participants, Grade 2 | 1.7 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | Achieved HbA1c target, Grade 1, n=73, 70, 55 | 3.0 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | Achieved HbA1c target, Grade 2 or 3, n=73, 70, 55 | 2.0 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | All participants, Grade 3 | 0 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | Achieved HbA1c target, Grade 2, n=73, 70, 55 | 2.0 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | All participants, Grade 1 | 2.7 hypoglycaemic events/participant/year |
| Insulin Detemir (Basal Insulin) | 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% | Achieved HbA1c target, Grade 3, n=73, 70, 55 | 0 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | All participants, Grade 3 | 0 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | Achieved HbA1c target, Grade 3, n=73, 70, 55 | 0 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | All participants, Grade 1 | 5.7 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | All participants, Grade 2 | 5.5 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | Achieved HbA1c target, Grade 2 or 3, n=73, 70, 55 | 5.5 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | All participants, Grade 2 or 3 | 5.7 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | Achieved HbA1c target, Grade 1, n=73, 70, 55 | 5.7 hypoglycaemic events/participant/year |
| Insulin Aspart (Prandial Insulin) | 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% | Achieved HbA1c target, Grade 2, n=73, 70, 55 | 5.3 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | Achieved HbA1c target, Grade 2 or 3, n=73, 70, 55 | 3.0 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | All participants, Grade 1 | 3.8 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | All participants, Grade 3 | 0 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | All participants, Grade 2 or 3 | 3.0 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | Achieved HbA1c target, Grade 1, n=73, 70, 55 | 3.0 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | Achieved HbA1c target, Grade 2, n=73, 70, 55 | 2.7 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | Achieved HbA1c target, Grade 3, n=73, 70, 55 | 0 hypoglycaemic events/participant/year |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | All participants, Grade 2 | 3.0 hypoglycaemic events/participant/year |
Secondary
Number of Participants Having an 'Other' Adverse Event
Time frame: Up to month 37 (36 months of treatment plus 1 month follow-up)
Population: Safety population consisting of all randomised participants exposed to at least one dose of trial drug(s).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Detemir (Basal Insulin) | Number of Participants Having an 'Other' Adverse Event | 227 participants |
| Insulin Aspart (Prandial Insulin) | Number of Participants Having an 'Other' Adverse Event | 235 participants |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Number of Participants Having an 'Other' Adverse Event | 228 participants |
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
Time frame: Month 36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Detemir (Basal Insulin) | Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5% | 43.2 percentage of participants |
| Insulin Aspart (Prandial Insulin) | Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5% | 44.8 percentage of participants |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5% | 31.9 percentage of participants |
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.
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Detemir (Basal Insulin) | 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% | Total participants who achieved target | 8.1 percentage of participants |
| Insulin Detemir (Basal Insulin) | 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% | Subset who achieved target, n=18, 50, 39 | 78.9 percentage of participants |
| Insulin Aspart (Prandial Insulin) | 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% | Total participants who achieved target | 23.9 percentage of participants |
| Insulin Aspart (Prandial Insulin) | 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% | Subset who achieved target, n=18, 50, 39 | 43.9 percentage of participants |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | Total participants who achieved target | 17.0 percentage of participants |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | 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% | Subset who achieved target, n=18, 50, 39 | 52.5 percentage of participants |
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.
Time frame: Month 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Detemir (Basal Insulin) | Percentage of Participants Who Required A Second Insulin Therapy by Month 12 | 17.9 percentage of participants |
| Insulin Aspart (Prandial Insulin) | Percentage of Participants Who Required A Second Insulin Therapy by Month 12 | 4.2 percentage of participants |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Percentage of Participants Who Required A Second Insulin Therapy by Month 12 | 8.9 percentage of participants |
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.
Time frame: Month 36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Detemir (Basal Insulin) | Percentage of Participants Who Required A Second Insulin Therapy by Month 36 | 89 percentage of participants |
| Insulin Aspart (Prandial Insulin) | Percentage of Participants Who Required A Second Insulin Therapy by Month 36 | 82 percentage of participants |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Percentage of Participants Who Required A Second Insulin Therapy by Month 36 | 88 percentage of participants |
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.
Time frame: Month 12
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Insulin Detemir (Basal Insulin) | Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months | 0.78 units on a scale |
| Insulin Aspart (Prandial Insulin) | Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months | 0.76 units on a scale |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months | 0.76 units on a scale |
Secondary
Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 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.
Time frame: Month 36
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Insulin Detemir (Basal Insulin) | Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months | 0.80 units on a scale |
| Insulin Aspart (Prandial Insulin) | Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months | 0.77 units on a scale |
| Biphasic Insulin Aspart 30 (Biphasic Insulin) | Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months | 0.76 units on a scale |