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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
708
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir
HbA1c (Glycosylated Haemoglobin) at Month 12
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Time frame: Baseline, Month 12
HbA1c (Glycosylated Haemoglobin) at Month 36
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Time frame: Baseline, Month 36
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
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
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%.
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Novo Nordisk Investigational Site
Dublin, Ireland
Novo Nordisk Investigational Site
Dublin, Ireland
Novo Nordisk Investigational Site
Dublin, Ireland
Novo Nordisk Investigational Site
Galway, Ireland
Novo Nordisk Investigational Site
Aberdeen, United Kingdom
Novo Nordisk Investigational Site
Addlestone, United Kingdom
Novo Nordisk Investigational Site
Airdrie, United Kingdom
Novo Nordisk Investigational Site
Ashton-under-Lyne, United Kingdom
Novo Nordisk Investigational Site
Ayr, United Kingdom
Novo Nordisk Investigational Site
Belfast, United Kingdom
...and 53 more locations
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: Month 36
Change From Baseline in Body Weight at Month 12
Time frame: Week 0 (baseline), month 12
Change From Baseline in Body Weight at Month 36
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 36
Number of Participants Having an 'Other' Adverse Event
Time frame: Up to month 37 (36 months of treatment plus 1 month follow-up)