| Outcome Measures: |
Primary: 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 | 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., Month 12|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, Month 36|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%., Month 12|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%., Month 36|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., Month 12|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., Month 36|Change From Baseline in Body Weight at Month 12, Week 0 (baseline), month 12|Change From Baseline in Body Weight at Month 36, Week 0 (baseline), month 36|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., Baseline, month 12|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., Baseline, month 36|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., Month 12|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., Month 36|Number of Participants Having an 'Other' Adverse Event, Up to month 37 (36 months of treatment plus 1 month follow-up)
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| Locations: |
Novo Nordisk Investigational Site, Dublin, DUBLIN 15, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 7, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 8, Ireland|Novo Nordisk Investigational Site, Galway, Ireland|Novo Nordisk Investigational Site, Aberdeen, AB25 1LD, United Kingdom|Novo Nordisk Investigational Site, Addlestone, KT15 2BH, United Kingdom|Novo Nordisk Investigational Site, Airdrie, ML6 0JS, United Kingdom|Novo Nordisk Investigational Site, Ashton-Under-Lyne, OL6 9RW, United Kingdom|Novo Nordisk Investigational Site, Ayr, KA6 6DX, United Kingdom|Novo Nordisk Investigational Site, Belfast, BT12 6BA, United Kingdom|Novo Nordisk Investigational Site, Belfast, BT37 9RH, United Kingdom|Novo Nordisk Investigational Site, Belfast, BT9 78B, United Kingdom|Novo Nordisk Investigational Site, Berkshire, RG7 3SQ, United Kingdom|Novo Nordisk Investigational Site, Birmingham, B71 4HJ, United Kingdom|Novo Nordisk Investigational Site, Birmingham, B9 5SS, United Kingdom|Novo Nordisk Investigational Site, Bournemouth, BH7 7DW, United Kingdom|Novo Nordisk Investigational Site, Bradford, BD9 6RJ, United Kingdom|Novo Nordisk Investigational Site, Bristol, BS10 5NB, United Kingdom|Novo Nordisk Investigational Site, Bury St Edmunds, IP30 9QU, United Kingdom|Novo Nordisk Investigational Site, Cambridge, CB2 2QQ, United Kingdom|Novo Nordisk Investigational Site, Colchester, CO4 5JL, United Kingdom|Novo Nordisk Investigational Site, Coventry, CV1 4FH, United Kingdom|Novo Nordisk Investigational Site, Crawley, RH10 7DH, United Kingdom|Novo Nordisk Investigational Site, Derby, DE22 3DT, United Kingdom|Novo Nordisk Investigational Site, Dundee, DD1 9SY, United Kingdom|Novo Nordisk Investigational Site, Edinburgh, EH16 4SA, United Kingdom|Novo Nordisk Investigational Site, Exeter, EX2 5AX, United Kingdom|Novo Nordisk Investigational Site, Gillingham, ME7 5NY, United Kingdom|Novo Nordisk Investigational Site, Glasgow, G4 0SF, United Kingdom|Novo Nordisk Investigational Site, Guildford, GU2 7XX, United Kingdom|Novo Nordisk Investigational Site, Haywards Heath, RH16 4EX, United Kingdom|Novo Nordisk Investigational Site, Headington, OX3 7LE, United Kingdom|Novo Nordisk Investigational Site, High Wycombe, HP11 2TZ, United Kingdom|Novo Nordisk Investigational Site, Hull, HU3 2JZ, United Kingdom|Novo Nordisk Investigational Site, Kettering, NN16 8UZ, United Kingdom|Novo Nordisk Investigational Site, Leeds, LS9 7TF, United Kingdom|Novo Nordisk Investigational Site, Leicester, LE1 5WW, United Kingdom|Novo Nordisk Investigational Site, Leicester, LE5 4PW, United Kingdom|Novo Nordisk Investigational Site, Liverpool, L7 8XP, United Kingdom|Novo Nordisk Investigational Site, Liverpool, L9 7AL, United Kingdom|Novo Nordisk Investigational Site, Livingstone, EH54 6PP, United Kingdom|Novo Nordisk Investigational Site, London, N19 3UA, United Kingdom|Novo Nordisk Investigational Site, London, SE5 9RS, United Kingdom|Novo Nordisk Investigational Site, London, United Kingdom|Novo Nordisk Investigational Site, Manchester, M13 0JE, United Kingdom|Novo Nordisk Investigational Site, Manchester, M23 9LT, United Kingdom|Novo Nordisk Investigational Site, Manchester, M41 5SL, United Kingdom|Novo Nordisk Investigational Site, Manchester, M8 5RB, United Kingdom|Novo Nordisk Investigational Site, Middlesborough, TS3 4BW, United Kingdom|Novo Nordisk Investigational Site, Newcastle, NE29 0LR, United Kingdom|Novo Nordisk Investigational Site, Newcastle, NE4 6BE, United Kingdom|Novo Nordisk Investigational Site, Norfolk, NR4 7UZ, United Kingdom|Novo Nordisk Investigational Site, Northampton, NN1 5BD, United Kingdom|Novo Nordisk Investigational Site, Nottingham, NG7 2UH, United Kingdom|Novo Nordisk Investigational Site, Plymouth, PL8 8DQ, United Kingdom|Novo Nordisk Investigational Site, Rugby, CV22 5PX, United Kingdom|Novo Nordisk Investigational Site, Sheffield, S5 7AU, United Kingdom|Novo Nordisk Investigational Site, Skipton, BD23 1EU, United Kingdom|Novo Nordisk Investigational Site, Stevenage, SG1 4AB, United Kingdom|Novo Nordisk Investigational Site, Torquay, TQ2 7AA, United Kingdom|Novo Nordisk Investigational Site, Welwyn Garden City, AL7 4HQ, United Kingdom|Novo Nordisk Investigational Site, Whiston, L35 5DR, United Kingdom|Novo Nordisk Investigational Site, Wirral, Merseyside, CH63 4JY, United Kingdom
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