Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.
Interventions
DRUGliraglutide
Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.
DRUGinsulin detemir
Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm
DRUGmetformin
Metformin tablets, at least 1500 mg/day
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 84 Years
Healthy volunteers
No
Inclusion criteria
* Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. Previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the Investigator * HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy * HbA1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulphonylurea
Exclusion criteria
* Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator) * Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening * Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator * Impaired kidney function * Impaired liver function * Uncontrolled treated/untreated hypertension * Cancer or any clinically significant disease or disorder as judged by the Investigator * Previous participation in the run-in phase of this trial. Re-screening is allowed once * History of chronic pancreatitis or idiopathic pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26. | Week 0 (Randomisation), week 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF) | Week 0, Week 52 | — |
| Mean Change From Randomisation in Fasting Plasma Glucose at Week 26 | Week 0 (Randomisation), Week 26 | — |
| Mean Change From Randomisation in Fasting Plasma Glucose at Week 52 | Week 0, Week 52 | — |
| Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 | Week 0 (Randomisation), Week 26 | Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively. |
| Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52 | Week 0, Week 52 | Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively. |
| Mean Change From Randomisation in Fasting Insulin at Week 26 | Week 0 (Randomisation), Week 26 | — |
| Mean Change From Randomisation in Fasting Insulin at Week 52 | Week 0 (Randomisation), Week 52 | — |
| Mean Change From Randomisation in Fasting Pro-insulin at Week 26. | Week 0 (Randomisation), Week 26 | — |
| Mean Change From Randomisation in Fasting Pro-insulin at Week 52 | Week 0, Week 52 | — |
| Mean Change From Randomisation in Fasting C-peptide at Week 26. | Week 0 (Randomisation), Week 26 | — |
| Mean Change From Randomisation in Fasting C-peptide at Week 52. | Week 0, Week 52 | — |
| Mean Changes From Randomisation in Cholesterol Lipids at Week 26. | Week 0 (Randomisation), Week 26 | Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C) |
| Mean Changes From Randomisation in Cholesterol Lipids at Week 52. | Week 0, Week 52 | Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C) |
| Mean Change From Randomisation in Lipids: Triglycerides at Week 26 | Week 0 (Randomisation), Week 26 | — |
| Mean Change From Randomisation in Lipids: Triglycerides at Week 52 | Week 0, Week 52 | — |
| Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group) | Week 0, Week 52 | — |
| Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52 | Week 0, Week 52 | — |
| Mean Change From Randomisation in Body Weight at Week 26 | Week 0 (Randomisation), Week 26 | — |
| Mean Change From Randomisation in Body Weight at Week 52 | Week 0, Week 52 | — |
| Mean Change From Randomisation in Waist Circumference at Week 26. | Week 0 (Randomisation), Week 26 | — |
| Mean Change From Randomisation in Waist Circumference at Week 52. | Week 0, Week 52 | — |
| Mean Change From Randomisation in Hip Circumference at Week 26 | Week 0 (Randomisation), Week 26 | — |
| Mean Change From Randomisation in Hip Circumference at Week 52 | Week 0, week 52 | — |
| Mean Change From Randomisation in Waist to Hip Ratio at Week 26 | Week 0 (Randomisation), Week 26 | Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference |
| Mean Change From Randomisation in Waist to Hip Ratio at Week 52 | Week 0, Week 52 | Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference |
| Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26. | Week 0 (Randomisation), Week 26 | — |
| Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52. | Week 0, Week 52 | — |
| Adverse Events From Run-in (Week -12) to Week 52 | Run-in (week -12) to Week 52 | — |
| Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | weeks 0-26 | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. |
| Hypoglycaemic Episodes Weeks 0-52 | Week 0-52 | Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. |
| Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26 | Week 0 (Randomisation), Week 26 | — |
Countries
Belgium, Canada, France, Germany, Italy, Netherlands, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Recruitment details
A total of 202 centres in 9 countries: Belgium (2), Canada (7), France (19), Germany (37), Italy (18), the Netherlands (16), Spain (14), the United Kingdom (32) and the United States (57)
Pre-assignment details
Subjects on metformin and/or sulpholynurea treatment underwent a 12-week run-in period with liraglutide + metformin. Subjects not achieving an HbA1c below 7% were randomised to liraglutide + metformin treatment with/without insulin detemir. Subjects achieving an HbA1c below 7% continued liraglutide + metformin treatment.
Participants by arm
| Arm | Count |
|---|---|
| Lira 1.8 Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0% | 161 |
| Insulin Detemir + Lira 1.8 Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0% | 162 |
| Non-Randomised Lira 1.8 Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0% | 498 |
| Early Withdrawals Lira 1.8 Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial | 166 |
| Intensified Group Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group. | 24 |
| Total | 1,011 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Extension Period, Weeks 26-52 | Adverse Event | 3 | 3 | 10 | 0 | 0 |
| Extension Period, Weeks 26-52 | Lack of Efficacy | 4 | 2 | 2 | 0 | 0 |
| Extension Period, Weeks 26-52 | Lost to Follow-up | 0 | 5 | 2 | 0 | 0 |
| Extension Period, Weeks 26-52 | Protocol Violation | 6 | 2 | 5 | 0 | 0 |
| Extension Period, Weeks 26-52 | Unclassified | 4 | 2 | 11 | 0 | 0 |
| Extension Period, Weeks 26-52 | Withdrawal Criteria | 2 | 0 | 8 | 0 | 0 |
| Main Period, Weeks 0-26 | Adverse Event | 6 | 4 | 9 | 0 | 0 |
| Main Period, Weeks 0-26 | Lack of Efficacy | 5 | 2 | 0 | 0 | 0 |
| Main Period, Weeks 0-26 | Lost to Follow-up | 1 | 1 | 2 | 0 | 0 |
| Main Period, Weeks 0-26 | Protocol Violation | 4 | 5 | 7 | 0 | 0 |
| Main Period, Weeks 0-26 | Unclassified | 7 | 6 | 7 | 0 | 0 |
| Main Period, Weeks 0-26 | Withdrawal Criteria | 11 | 0 | 3 | 0 | 0 |
| Run-in Period, Weeks -12-0 | Adverse Event | 0 | 0 | 0 | 92 | 0 |
| Run-in Period, Weeks -12-0 | Lack of Efficacy | 0 | 0 | 0 | 6 | 0 |
| Run-in Period, Weeks -12-0 | Lost to Follow-up | 0 | 0 | 0 | 11 | 0 |
| Run-in Period, Weeks -12-0 | Protocol Violation | 0 | 0 | 0 | 24 | 0 |
| Run-in Period, Weeks -12-0 | Unclassified | 0 | 0 | 0 | 24 | 0 |
| Run-in Period, Weeks -12-0 | Withdrawal Criteria | 0 | 0 | 0 | 10 | 0 |
Baseline characteristics
| Characteristic | Insulin Detemir + Lira 1.8 | Total | Lira 1.8 | Intensified Group | Early Withdrawals Lira 1.8 | Non-Randomised Lira 1.8 |
|---|---|---|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 9.5 | 56.9 years STANDARD_DEVIATION 9.7 | 57.5 years STANDARD_DEVIATION 9.8 | 54.3 years STANDARD_DEVIATION 10.3 | 58.7 years STANDARD_DEVIATION 10.8 | 56.7 years STANDARD_DEVIATION 9.7 |
| Body Mass Index (BMI) | 34.9 kg/m^2 STANDARD_DEVIATION 6.3 | 34.4 kg/m^2 STANDARD_DEVIATION 6.5 | 33.9 kg/m^2 STANDARD_DEVIATION 6 | 36.5 kg/m^2 STANDARD_DEVIATION 7.7 | 31.8 kg/m^2 STANDARD_DEVIATION 6 | 34.4 kg/m^2 STANDARD_DEVIATION 6.7 |
| Body weight | 99.5 kg STANDARD_DEVIATION 21.2 | 99 kg STANDARD_DEVIATION 21 | 98.6 kg STANDARD_DEVIATION 21.3 | 109 kg STANDARD_DEVIATION 25.7 | 90.2 kg STANDARD_DEVIATION 18.5 | 99 kg STANDARD_DEVIATION 20.8 |
| Diabetes History | 8.6 years STANDARD_DEVIATION 5.8 | 7.4 years STANDARD_DEVIATION 5.8 | 8.5 years STANDARD_DEVIATION 6 | 6.8 years STANDARD_DEVIATION 5.4 | 8.4 years STANDARD_DEVIATION 6.4 | 6.6 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 128 Participants | 25 Participants | 5 Participants | 28 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 140 Participants | 883 Participants | 136 Participants | 19 Participants | 138 Participants | 450 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fasting plasma glucose (FPG) | 10.2 mmol/L STANDARD_DEVIATION 2.4 | 9.6 mmol/L STANDARD_DEVIATION 2.1 | 10.3 mmol/L STANDARD_DEVIATION 2.5 | 10.4 mmol/L STANDARD_DEVIATION 2.3 | 9.5 mmol/L STANDARD_DEVIATION 3 | 9.2 mmol/L STANDARD_DEVIATION 1.8 |
| Glycosylated haemoglobin (HbA1c) | 8.2 Percentage point of total HbA1c STANDARD_DEVIATION 0.7 | 7.9 Percentage point of total HbA1c STANDARD_DEVIATION 0.8 | 8.3 Percentage point of total HbA1c STANDARD_DEVIATION 0.8 | 8.4 Percentage point of total HbA1c STANDARD_DEVIATION 0.7 | 8 Percentage point of total HbA1c STANDARD_DEVIATION 0.8 | 7.7 Percentage point of total HbA1c STANDARD_DEVIATION 0.7 |
| Height | 1.69 meter STANDARD_DEVIATION 0.11 | 1.69 meter STANDARD_DEVIATION 0.1 | 1.7 meter STANDARD_DEVIATION 0.1 | 1.72 meter STANDARD_DEVIATION 0.09 | 1.68 meter STANDARD_DEVIATION 0.1 | 1.7 meter STANDARD_DEVIATION 0.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 14 Participants | 1 Participants | 0 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 56 Participants | 17 Participants | 1 Participants | 11 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 16 Participants | 2 Participants | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) White | 144 Participants | 923 Participants | 141 Participants | 22 Participants | 146 Participants | 470 Participants |
| Sex: Female, Male Female | 74 Participants | 448 Participants | 72 Participants | 11 Participants | 75 Participants | 216 Participants |
| Sex: Female, Male Male | 88 Participants | 563 Participants | 89 Participants | 13 Participants | 91 Participants | 282 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 100 / 159 | 102 / 163 | 310 / 499 | 122 / 166 | 11 / 24 |
| serious Total, serious adverse events | 11 / 159 | 17 / 163 | 62 / 499 | 6 / 166 | 1 / 24 |
Outcome results
Primary
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.
Time frame: Week 0 (Randomisation), week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26. | 0.02 Percentage point of total HbA1c | Standard Error 0.07 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26. | -0.51 Percentage point of total HbA1c | Standard Error 0.07 |
Comparison: The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5% and with the power of 90%.95% CI: [-0.68, -0.36]ANCOVA
Secondary
Adverse Events From Run-in (Week -12) to Week 52
Time frame: Run-in (week -12) to Week 52
Population: The Safety Analysis Set included all exposed subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lira 1.8 | Adverse Events From Run-in (Week -12) to Week 52 | 716 events |
| Insulin Detemir + Lira 1.8 | Adverse Events From Run-in (Week -12) to Week 52 | 845 events |
| Non-Randomised Lira 1.8 | Adverse Events From Run-in (Week -12) to Week 52 | 2389 events |
| Early Withdrawals Lira 1.8 | Adverse Events From Run-in (Week -12) to Week 52 | 383 events |
| Intensified Group | Adverse Events From Run-in (Week -12) to Week 52 | 30 events |
Secondary
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: weeks 0-26
Population: The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lira 1.8 | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Major | 0 episodes |
| Lira 1.8 | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Symptoms only | 9 episodes |
| Lira 1.8 | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Minor | 2 episodes |
| Insulin Detemir + Lira 1.8 | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Minor | 22 episodes |
| Insulin Detemir + Lira 1.8 | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Major | 0 episodes |
| Insulin Detemir + Lira 1.8 | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Symptoms only | 19 episodes |
| Non-Randomised Lira 1.8 | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Symptoms only | 26 episodes |
| Non-Randomised Lira 1.8 | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Major | 0 episodes |
| Non-Randomised Lira 1.8 | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Minor | 31 episodes |
Secondary
Hypoglycaemic Episodes Weeks 0-52
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Week 0-52
Population: The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Major | 0 episodes |
| Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Minor | 4 episodes |
| Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Symptoms only | 14 episodes |
| Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Unknown | 0 episodes |
| Insulin Detemir + Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Minor | 33 episodes |
| Insulin Detemir + Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Symptoms only | 57 episodes |
| Insulin Detemir + Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Unknown | 1 episodes |
| Insulin Detemir + Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Major | 0 episodes |
| Non-Randomised Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Symptoms only | 42 episodes |
| Non-Randomised Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Minor | 53 episodes |
| Non-Randomised Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Unknown | 2 episodes |
| Non-Randomised Lira 1.8 | Hypoglycaemic Episodes Weeks 0-52 | Major | 0 episodes |
| Intensified Group | Hypoglycaemic Episodes Weeks 0-52 | Unknown | 0 episodes |
| Intensified Group | Hypoglycaemic Episodes Weeks 0-52 | Minor | 1 episodes |
| Intensified Group | Hypoglycaemic Episodes Weeks 0-52 | Major | 0 episodes |
| Intensified Group | Hypoglycaemic Episodes Weeks 0-52 | Symptoms only | 2 episodes |
Secondary
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26
Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 | Change at Breakfast, N=133, 144 | -0.97 mmol/L | Standard Error 0.26 |
| Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 | Change at Lunch, N= 134, 143 | -0.83 mmol/L | Standard Error 0.22 |
| Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 | Change at Dinner, N= 133, 139 | -0.48 mmol/L | Standard Error 0.24 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 | Change at Breakfast, N=133, 144 | -2.09 mmol/L | Standard Error 0.26 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 | Change at Lunch, N= 134, 143 | -1.43 mmol/L | Standard Error 0.22 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 | Change at Dinner, N= 133, 139 | -1.18 mmol/L | Standard Error 0.24 |
Secondary
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52
Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52 | Change at Lunch, N= 145, 136 | -0.51 mmol/L | Standard Error 0.25 |
| Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52 | Change at Breakfast, N=148, 135 | -0.68 mmol/L | Standard Error 0.25 |
| Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52 | Change at Dinner, N= 144, 135 | -0.96 mmol/L | Standard Error 0.26 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52 | Change at Lunch, N= 145, 136 | -1.14 mmol/L | Standard Error 0.25 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52 | Change at Breakfast, N=148, 135 | -2.43 mmol/L | Standard Error 0.25 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52 | Change at Dinner, N= 144, 135 | -1.4 mmol/L | Standard Error 0.25 |
Secondary
Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26. | Systolic Blood Pressure | 1.11 mmHg | Standard Error 1.22 |
| Lira 1.8 | Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26. | Diastolic Blood Pressure | -1.1 mmHg | Standard Error 0.77 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26. | Systolic Blood Pressure | 0.41 mmHg | Standard Error 1.23 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26. | Diastolic Blood Pressure | -0.4 mmHg | Standard Error 0.78 |
Secondary
Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52. | Systolic Blood Pressure | -0.74 mmHg | Standard Error 1.2 |
| Lira 1.8 | Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52. | Diastolic Blood Pressure | -0.66 mmHg | Standard Error 0.78 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52. | Systolic Blood Pressure | 0.16 mmHg | Standard Error 1.21 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52. | Diastolic Blood Pressure | 0.11 mmHg | Standard Error 0.79 |
Secondary
Mean Change From Randomisation in Body Weight at Week 26
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Body Weight at Week 26 | -0.95 kg | Standard Error 0.31 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Body Weight at Week 26 | -0.16 kg | Standard Error 0.31 |
Secondary
Mean Change From Randomisation in Body Weight at Week 52
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (last observation carried forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Body Weight at Week 52 | -1.02 kg | Standard Error 0.41 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Body Weight at Week 52 | -0.05 kg | Standard Error 0.42 |
Secondary
Mean Change From Randomisation in Fasting C-peptide at Week 26.
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Fasting C-peptide at Week 26. | -0.08 mmol/L | Standard Error 0.04 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Fasting C-peptide at Week 26. | -0.32 mmol/L | Standard Error 0.04 |
Secondary
Mean Change From Randomisation in Fasting C-peptide at Week 52.
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Fasting C-peptide at Week 52. | 0.02 mmol/L | Standard Error 0.05 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Fasting C-peptide at Week 52. | -0.34 mmol/L | Standard Error 0.05 |
Secondary
Mean Change From Randomisation in Fasting Insulin at Week 26
Time frame: Week 0 (Randomisation), Week 26
Population: Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.
Secondary
Mean Change From Randomisation in Fasting Insulin at Week 52
Time frame: Week 0 (Randomisation), Week 52
Population: Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.
Secondary
Mean Change From Randomisation in Fasting Plasma Glucose at Week 26
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Fasting Plasma Glucose at Week 26 | -0.39 mmol/L | Standard Error 0.19 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Fasting Plasma Glucose at Week 26 | -2.12 mmol/L | Standard Error 0.19 |
Secondary
Mean Change From Randomisation in Fasting Plasma Glucose at Week 52
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Fasting Plasma Glucose at Week 52 | -0.14 mmol/L | Standard Error 0.21 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Fasting Plasma Glucose at Week 52 | -1.91 mmol/L | Standard Error 0.21 |
Secondary
Mean Change From Randomisation in Fasting Pro-insulin at Week 26.
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Fasting Pro-insulin at Week 26. | -1.12 pmol/L | Standard Error 3.27 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Fasting Pro-insulin at Week 26. | -9.78 pmol/L | Standard Error 3.22 |
Secondary
Mean Change From Randomisation in Fasting Pro-insulin at Week 52
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Fasting Pro-insulin at Week 52 | 1.47 pmol/L | Standard Error 3.08 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Fasting Pro-insulin at Week 52 | -4 pmol/L | Standard Error 3.08 |
Secondary
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group) | -0.1 Percentage point of total HbA1c | Standard Error 0.09 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group) | -0.51 Percentage point of total HbA1c | Standard Error 0.09 |
Comparison: The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5%.95% CI: [-0.6, -0.21]ANCOVA
Secondary
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) includes LOCF of last observation before intensification for randomised Lira 1.8 mg treatment group subjects who were intensified.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF) | 0.01 Percentage point of total HbA1c | Standard Error 0.09 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF) | -0.5 Percentage point of total HbA1c | Standard Error 0.09 |
95% CI: [-0.7, -0.31]ANCOVA
Secondary
Mean Change From Randomisation in Hip Circumference at Week 26
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Hip Circumference at Week 26 | -0.36 cm | Standard Error 0.46 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Hip Circumference at Week 26 | -0.38 cm | Standard Error 0.45 |
Secondary
Mean Change From Randomisation in Hip Circumference at Week 52
Time frame: Week 0, week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Hip Circumference at Week 52 | -0.79 cm | Standard Error 0.5 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Hip Circumference at Week 52 | -0.28 cm | Standard Error 0.49 |
Secondary
Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26 | -0.03 mmol/L | Standard Error 0.02 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26 | -0.11 mmol/L | Standard Error 0.02 |
Secondary
Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52 | -0.03 mmol/L | Standard Error 0.03 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52 | -0.07 mmol/L | Standard Error 0.03 |
Secondary
Mean Change From Randomisation in Lipids: Triglycerides at Week 26
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Lipids: Triglycerides at Week 26 | -0.24 mmol/L | Standard Error 0.11 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Lipids: Triglycerides at Week 26 | -0.33 mmol/L | Standard Error 0.11 |
Secondary
Mean Change From Randomisation in Lipids: Triglycerides at Week 52
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Lipids: Triglycerides at Week 52 | -0.22 mmol/L | Standard Error 0.11 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Lipids: Triglycerides at Week 52 | -0.37 mmol/L | Standard Error 0.11 |
Secondary
Mean Change From Randomisation in Waist Circumference at Week 26.
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Waist Circumference at Week 26. | -0.66 cm | Standard Error 0.46 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Waist Circumference at Week 26. | -0.78 cm | Standard Error 0.46 |
Secondary
Mean Change From Randomisation in Waist Circumference at Week 52.
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Waist Circumference at Week 52. | -0.83 participants | Standard Error 0.54 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Waist Circumference at Week 52. | -0.83 participants | Standard Error 0.53 |
Secondary
Mean Change From Randomisation in Waist to Hip Ratio at Week 26
Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Waist to Hip Ratio at Week 26 | -0.00356 cm/cm | Standard Error 0.004071 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Waist to Hip Ratio at Week 26 | -0.00332 cm/cm | Standard Error 0.004032 |
Secondary
Mean Change From Randomisation in Waist to Hip Ratio at Week 52
Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.8 | Mean Change From Randomisation in Waist to Hip Ratio at Week 52 | -0.00146 cm/cm | Standard Error 0.004165 |
| Insulin Detemir + Lira 1.8 | Mean Change From Randomisation in Waist to Hip Ratio at Week 52 | -0.00438 cm/cm | Standard Error 0.004126 |
Secondary
Mean Changes From Randomisation in Cholesterol Lipids at Week 26.
Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)
Time frame: Week 0 (Randomisation), Week 26
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 26. | Change in Total Cholesterol | 0.04 mmol/L | Standard Error 0.07 |
| Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 26. | Change in LDL-C | -0.04 mmol/L | Standard Error 0.06 |
| Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 26. | Change in VLDL-C | 0.05 mmol/L | Standard Error 0.03 |
| Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 26. | Change in HDL-C | 0.02 mmol/L | Standard Error 0.01 |
| Insulin Detemir + Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 26. | Change in HDL-C | 0.05 mmol/L | Standard Error 0.01 |
| Insulin Detemir + Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 26. | Change in Total Cholesterol | 0.05 mmol/L | Standard Error 0.07 |
| Insulin Detemir + Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 26. | Change in VLDL-C | 0.01 mmol/L | Standard Error 0.03 |
| Insulin Detemir + Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 26. | Change in LDL-C | -0.03 mmol/L | Standard Error 0.06 |
Secondary
Mean Changes From Randomisation in Cholesterol Lipids at Week 52.
Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)
Time frame: Week 0, Week 52
Population: The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 52. | Change in Total Cholesterol | -0.02 mmol/L | Standard Error 0.08 |
| Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 52. | Change in LDL-C | -0.08 mmol/L | Standard Error 0.07 |
| Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 52. | Change in VLDL-C | 0.03 mmol/L | Standard Error 0.04 |
| Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 52. | Change in HDL-C | 0.02 mmol/L | Standard Error 0.02 |
| Insulin Detemir + Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 52. | Change in HDL-C | 0.07 mmol/L | Standard Error 0.02 |
| Insulin Detemir + Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 52. | Change in Total Cholesterol | -0.03 mmol/L | Standard Error 0.08 |
| Insulin Detemir + Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 52. | Change in VLDL-C | -0.03 mmol/L | Standard Error 0.04 |
| Insulin Detemir + Lira 1.8 | Mean Changes From Randomisation in Cholesterol Lipids at Week 52. | Change in LDL-C | -0.1 mmol/L | Standard Error 0.07 |