Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone. The trial has been extended by 52 weeks. The extension will consist of two 26-week periods: 1. Week 27-52 after randomisation \- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen. 2. Week 53-78 after randomisation * Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals. * Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.
Interventions
DRUGliraglutide
1.2 mg once daily, subcutaneous (under the skin) injection
DRUGsitagliptin
Tablets, 100 mg daily
DRUGmetformin
Tablets, minimum 1500 mg daily
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Treatment with metformin alone for at least three months * HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive) * Body Mass Index (BMI) less than or equal to 45.0
Exclusion criteria
* Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors * Treatment with anti-diabetic drugs other than metformin within the last three months * Any serious medical condition * Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. |
| Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52. |
| Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 | Week 0, Week 78 | Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78. |
| Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 | Week 52, Week 78 | Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52 | Week 0, Week 52 | Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 52 |
| Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 | Week 0, Week 78 | Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the FAS. |
| Mean Change From Baseline in Body Weight at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in body weight at Week 26. |
| Mean Change From Baseline in Body Weight at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in body weight at Week 52. |
| Mean Change in Body Weight From Week 52 to Week 78 | Week 52, Week 78 | Mean change in body weight from Week 52 to Week 78. |
| Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26. |
| Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52. |
| Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78 | Week 0, Week 78 | Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78. |
| Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78 | Week 52, Week 78 | Mean change in fasting plasma glucose (FPG) Week 52 to Week 78. |
| Mean Change From Baseline in Beta-cell Function at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). |
| Mean Change From Baseline in Beta-cell Function at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). |
| Mean Change in Beta-cell Function From Week 52 to Week 78 | Week 52, Week 78 | Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B). |
| Mean Change From Baseline in Total Cholesterol at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26. |
| Mean Change From Baseline in Total Cholesterol at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52. |
| Mean Change in Total Cholesterol From Week 52 to Week 78 | Week 52, Week 78 | Mean change in total cholesterol from Week 52 to Week 78 |
| Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26. |
| Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52. |
| Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78 | Week 52, Week 78 | Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78. |
| Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26. |
| Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52. |
| Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78 | Week 52, Week 78 | Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78. |
| Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26 | Week 0, Week 26 | Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26. |
| Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 | Week 0, Week 52 | Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52. |
| Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78 | Week 52, Week 78 | Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78. |
| Mean Change From Baseline in Triglycerides (TG) at Week 26 | Week 0, Week 26 | Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26. |
| Mean Change From Baseline in Triglycerides (TG) at Week 52 | Week 0, Week 52 | Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52. |
| Mean Change in Triglycerides (TG) From Week 52 to Week 78 | Week 52, Week 78 | Mean change in triglycerides (TG) from Week 52 to Week 78. |
| Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26 | Week 0, Week 26 | Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26. |
| Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52 | Week 0, Week 52 | Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52. |
| Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78 | Week 52, Week 78 | Mean change in free fatty acids (FFA) from Week 52 to Week 78. |
| Mean Change From Baseline in Apolipoprotein B at Week 26 | Week 0, Week 26 | Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26. |
| Mean Change From Baseline in Apolipoprotein B at Week 52 | Week 0, Week 52 | Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52. |
| Mean Change in Apolipoprotein B From Week 52 to Week 78 | Week 52, Week 78 | Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78. |
| Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26. |
| Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26. | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26. |
| Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26. | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26. |
| Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. |
| Mean Change From Baseline in Adiponectin at Week 26. | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26. |
| Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. |
| Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26. | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis. |
| Mean Change From Baseline in Waist to Hip Ratio at Week 26. | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip. |
| Mean Change From Baseline in Waist to Hip Ratio at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip. |
| Mean Change in Waist to Hip Ratio From Week 52 to Week 78 | Week 52, Week 78 | Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip. |
| Mean Change From Baseline in Waist Circumference at Week 26. | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26 |
| Mean Change From Baseline in Waist Circumference at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52. |
| Mean Change in Waist Circumference From Week 52 to Week 78 | Week 52, Week 78 | Mean change in Waist Circumference from Week 52 to Week 78. |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26 |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52. |
| Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78 | Week 52, Week 78 | Mean change in systolic blood pressure (SBP) from Week 52 to Week 78. |
| Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26. |
| Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52. |
| Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78 | Week 52, Week 78 | Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78. |
| Mean Change From Baseline in Pulse at Week 26 | Week 0, Week 26 | Calculated as an estimate of the mean change from baseline in pulse at Week 26. |
| Mean Change From Baseline in Pulse at Week 52 | Week 0, Week 52 | Calculated as an estimate of the mean change from baseline in pulse at Week 52. |
| Mean Change in Pulse From Week 52 to Week 78 | Week 52, Week 78 | Mean change in pulse from Week 52 to Week 78. |
| Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26 | Week 0, Week 26 | The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. |
| Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52 | Week 0, Week 52 | The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. |
| Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78 | Week 52, Week 78 | The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36. |
| Hypoglyceamic Episodes, 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. |
| Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26 | Week 0, Week 26 | Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26 |
| Hypoglyceamic Episodes, Weeks 0-52 | 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. |
| Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | 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. |
| Hypoglyceamic Episodes, Weeks 0-78 | Weeks 0-78 | Number of hypoglycaemic episodes from Week 0 to Week 78, 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 (Excluding Outlier Subject), Weeks 0-78 | Weeks 0-78 | Number of hypoglycaemic episodes from Week 0 to Week 78, 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. |
| Hypoglycaamic Episodes, Weeks 52-78 | Week 52-78 | Number of hypoglycaemic episodes from Week 52 to Week 78, 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 (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. |
| Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52 | Week 0, Week 52 | Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 52 |
| Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 | Week 0, Week 78 | Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the FAS. |
| Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26 | Week 0, Week 26 | Calculated as the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 26 |
Countries
Canada, Croatia, France, Germany, Ireland, Italy, Netherlands, Puerto Rico, Romania, Serbia and Montenegro, Slovakia, Slovenia, Spain, United Kingdom, United States
Participant flow
Recruitment details
A total of 158 centres in 13 countries participated: Canada (11), Croatia (3), Germany (12), Ireland (5), Italy (8), Netherlands (8), Romania (4), Serbia (3), Slovakia (6), Slovenia (3), Spain (9), United Kingdom (20) and United States (66). Of the 158 sites approved by an Independent Ethics Committee, 151 actively screened and enrolled subjects.
Pre-assignment details
Between screening and randomisation, eligible subjects were to continue their usual pre-study metformin dose and dosing frequency.
Participants by arm
| Arm | Count |
|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | 225 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78). | 221 |
| Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). | 219 |
| Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin. | 0 |
| Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin. | 0 |
| Total | 665 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Week 0-26 (Main Period) | Adverse Event | 14 | 15 | 4 | 0 | 0 |
| Week 0-26 (Main Period) | Lack of Efficacy | 4 | 0 | 4 | 0 | 0 |
| Week 0-26 (Main Period) | Protocol Violation | 14 | 4 | 4 | 0 | 0 |
| Week 0-26 (Main Period) | Unclassified | 14 | 4 | 8 | 0 | 0 |
| Week 0-26 (Main Period) | Withdrawal criteria | 10 | 7 | 5 | 0 | 0 |
| Week 26-52 (Extension Period 1) | Adverse Event | 5 | 10 | 3 | 0 | 0 |
| Week 26-52 (Extension Period 1) | Lack of Efficacy | 2 | 3 | 7 | 0 | 0 |
| Week 26-52 (Extension Period 1) | Protocol Violation | 3 | 2 | 2 | 0 | 0 |
| Week 26-52 (Extension Period 1) | Unclassified | 4 | 3 | 1 | 0 | 0 |
| Week 26-52 (Extension Period 1) | Withdrawal criteria | 6 | 8 | 2 | 0 | 0 |
| Week 52-78 (Extension Period 2) | Adverse Event | 0 | 3 | 0 | 6 | 0 |
| Week 52-78 (Extension Period 2) | Lack of Efficacy | 3 | 3 | 0 | 0 | 0 |
| Week 52-78 (Extension Period 2) | Protocol Violation | 1 | 2 | 0 | 1 | 1 |
| Week 52-78 (Extension Period 2) | Unclassified | 2 | 4 | 0 | 0 | 1 |
| Week 52-78 (Extension Period 2) | Withdrawal criteria | 4 | 3 | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Sita -> Sita | Total |
|---|---|---|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 9.6 | 55.0 years STANDARD_DEVIATION 9.1 | 55.0 years STANDARD_DEVIATION 9 | 55.3 years STANDARD_DEVIATION 9.2 |
| Body Mass Index (BMI) at Screening | 32.6 kg/m^2 STANDARD_DEVIATION 5.2 | 33.1 kg/m^2 STANDARD_DEVIATION 5.1 | 32.6 kg/m^2 STANDARD_DEVIATION 5.4 | 32.8 kg/m^2 STANDARD_DEVIATION 5.2 |
| Duration of Diabetes | 6.0 years STANDARD_DEVIATION 4.5 | 6.4 years STANDARD_DEVIATION 5.4 | 6.3 years STANDARD_DEVIATION 5.4 | 6.2 years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 34 Participants | 35 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 186 Participants | 187 Participants | 184 Participants | 557 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fasting Plasma Glucose (FPG) at Randomisation | 10.1 mmol/L STANDARD_DEVIATION 2.4 | 9.9 mmol/L STANDARD_DEVIATION 2.4 | 10.0 mmol/L STANDARD_DEVIATION 2 | 10.0 mmol/L STANDARD_DEVIATION 2.3 |
| Glycosylated Haemoglobin A1c (HbA1c) at Randomisation | 8.4 Percentage point of total HbA1c STANDARD_DEVIATION 0.8 | 8.4 Percentage point of total HbA1c STANDARD_DEVIATION 0.7 | 8.5 Percentage point of total HbA1c STANDARD_DEVIATION 0.7 | 8.4 Percentage point of total HbA1c STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 4 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 16 Participants | 10 Participants | 48 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 8 Participants | 8 Participants | 25 Participants |
| Race (NIH/OMB) White | 184 Participants | 193 Participants | 199 Participants | 576 Participants |
| Sex: Female, Male Female | 109 Participants | 105 Participants | 99 Participants | 313 Participants |
| Sex: Female, Male Male | 116 Participants | 116 Participants | 120 Participants | 352 Participants |
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 | 120 / 221 | 134 / 218 | 106 / 219 |
| serious Total, serious adverse events | 12 / 221 | 19 / 218 | 17 / 219 |
Outcome results
Primary
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 | -1.24 Percentage point of total HbA1c | Standard Error 0.07 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 | -1.5 Percentage point of total HbA1c | Standard Error 0.06 |
| Sita -> Sita | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 | -0.9 Percentage point of total HbA1c | Standard Error 0.07 |
Comparison: ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.p-value: 0.000195% CI: [-0.77, -0.43]ANCOVA
Comparison: ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. Liraglutide 1.2 mg versus sitagliptin only tested if liraglutide 1.8 mg was superior to sitagliptin.p-value: 0.000195% CI: [-0.51, -0.16]ANCOVA
Primary
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 | -1.29 Percentage point of total HbA1c | Standard Error 0.07 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 | -1.51 Percentage point of total HbA1c | Standard Error 0.07 |
| Sita -> Sita | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 | -0.88 Percentage point of total HbA1c | Standard Error 0.07 |
Comparison: ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.p-value: 0.000195% CI: [-0.81, -0.44]ANCOVA
Comparison: ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.p-value: 0.000195% CI: [-0.59, -0.22]ANCOVA
Primary
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
Time frame: Week 0, Week 78
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 | -0.94 Percentage point of total HbA1c | Standard Error 0.08 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78 | -1.28 Percentage point of total HbA1c | Standard Error 0.07 |
Primary
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 | -0.24 Percentage point of total HbA1c | Standard Deviation 0.7 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78 | -0.45 Percentage point of total HbA1c | Standard Deviation 0.9 |
Comparison: The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.p-value: 0.00695% CI: [-0.41, -0.07]paired t-test
Comparison: The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.p-value: 0.000195% CI: [-0.67, -0.23]paired t-test
Secondary
Hypoglycaamic Episodes, Weeks 52-78
Number of hypoglycaemic episodes from Week 52 to Week 78, 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 52-78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaamic Episodes, Weeks 52-78 | Major | 1 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaamic Episodes, Weeks 52-78 | Minor | 12 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaamic Episodes, Weeks 52-78 | Symptoms only | 3 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaamic Episodes, Weeks 52-78 | Unclassified | 0 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaamic Episodes, Weeks 52-78 | Minor | 5 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaamic Episodes, Weeks 52-78 | Symptoms only | 11 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaamic Episodes, Weeks 52-78 | Unclassified | 0 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaamic Episodes, Weeks 52-78 | Major | 0 episodes |
| Sita -> Sita -> Lira 1.2 mg | Hypoglycaamic Episodes, Weeks 52-78 | Symptoms only | 1 episodes |
| Sita -> Sita -> Lira 1.2 mg | Hypoglycaamic Episodes, Weeks 52-78 | Minor | 3 episodes |
| Sita -> Sita -> Lira 1.2 mg | Hypoglycaamic Episodes, Weeks 52-78 | Unclassified | 0 episodes |
| Sita -> Sita -> Lira 1.2 mg | Hypoglycaamic Episodes, Weeks 52-78 | Major | 0 episodes |
| Sita -> Sita -> Lira 1.8 mg | Hypoglycaamic Episodes, Weeks 52-78 | Unclassified | 0 episodes |
| Sita -> Sita -> Lira 1.8 mg | Hypoglycaamic Episodes, Weeks 52-78 | Minor | 6 episodes |
| Sita -> Sita -> Lira 1.8 mg | Hypoglycaamic Episodes, Weeks 52-78 | Major | 0 episodes |
| Sita -> Sita -> Lira 1.8 mg | Hypoglycaamic Episodes, Weeks 52-78 | Symptoms only | 0 episodes |
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 is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Major | 1 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Minor | 17 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Symptoms only | 12 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Unclassified | 0 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Unclassified | 1 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Major | 0 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Symptoms only | 15 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Minor | 16 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Unclassified | 0 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Minor | 11 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Symptoms only | 10 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 | Major | 0 episodes |
Secondary
Hypoglycaemic Episodes (Excluding Outlier Subject), 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: Weeks 0-52
Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Unclassified | 0 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Major | 1 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Symptoms only | 14 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Minor | 24 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Symptoms only | 29 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Unclassified | 1 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Minor | 28 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Major | 0 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Unclassified | 0 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Minor | 25 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Symptoms only | 12 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 | Major | 0 episodes |
Secondary
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
Number of hypoglycaemic episodes from Week 0 to Week 78, 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 0-78
Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Major | 2 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Minor | 36 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Symptoms only | 18 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Unclassified | 0 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Unclassified | 1 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Major | 0 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Symptoms only | 40 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Minor | 33 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Unclassified | 0 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Minor | 34 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Symptoms only | 13 episodes |
| Sita -> Sita | Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 | Major | 0 episodes |
Secondary
Hypoglyceamic Episodes, 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 is all randomised subjects who had been exposed to at least one dose of the trial products.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-26 | Unclassified | 0 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-26 | Symptoms only | 12 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-26 | Major | 1 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-26 | Minor | 17 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-26 | Symptoms only | 15 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-26 | Major | 0 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-26 | Minor | 37 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-26 | Unclassified | 1 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-26 | Major | 0 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-26 | Minor | 11 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-26 | Unclassified | 0 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-26 | Symptoms only | 10 episodes |
Secondary
Hypoglyceamic 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: Weeks 0-52
Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-52 | Major | 1 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-52 | Minor | 24 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-52 | Symptoms only | 14 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-52 | Unclassified | 0 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-52 | Unclassified | 1 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-52 | Major | 0 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-52 | Symptoms only | 29 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-52 | Minor | 51 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-52 | Unclassified | 0 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-52 | Minor | 25 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-52 | Symptoms only | 12 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-52 | Major | 0 episodes |
Secondary
Hypoglyceamic Episodes, Weeks 0-78
Number of hypoglycaemic episodes from Week 0 to Week 78, 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 0-78
Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-78 | Unclassified | 0 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-78 | Minor | 36 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-78 | Symptoms only | 18 episodes |
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Hypoglyceamic Episodes, Weeks 0-78 | Major | 2 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-78 | Minor | 56 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-78 | Major | 0 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-78 | Symptoms only | 40 episodes |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Hypoglyceamic Episodes, Weeks 0-78 | Unclassified | 1 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-78 | Symptoms only | 13 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-78 | Minor | 34 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-78 | Major | 0 episodes |
| Sita -> Sita | Hypoglyceamic Episodes, Weeks 0-78 | Unclassified | 0 episodes |
Secondary
Mean Change From Baseline in Adiponectin at Week 26.
Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Adiponectin at Week 26. | 1.69 mcg/mL | Standard Error 0.19 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Adiponectin at Week 26. | 1.51 mcg/mL | Standard Error 0.19 |
| Sita -> Sita | Mean Change From Baseline in Adiponectin at Week 26. | 1.35 mcg/mL | Standard Error 0.19 |
Secondary
Mean Change From Baseline in Apolipoprotein B at Week 26
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Apolipoprotein B at Week 26 | -0.06 g/L | Standard Error 0.01 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Apolipoprotein B at Week 26 | -0.07 g/L | Standard Error 0.01 |
| Sita -> Sita | Mean Change From Baseline in Apolipoprotein B at Week 26 | -0.05 g/L | Standard Error 0.01 |
Secondary
Mean Change From Baseline in Apolipoprotein B at Week 52
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Apolipoprotein B at Week 52 | -0.03 g/L | Standard Error 0.01 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Apolipoprotein B at Week 52 | -0.03 g/L | Standard Error 0.01 |
| Sita -> Sita | Mean Change From Baseline in Apolipoprotein B at Week 52 | -0.03 g/L | Standard Error 0.01 |
Secondary
Mean Change From Baseline in Beta-cell Function at Week 26
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Beta-cell Function at Week 26 | 27.23 percentage point | Standard Error 3.82 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Beta-cell Function at Week 26 | 28.70 percentage point | Standard Error 3.75 |
| Sita -> Sita | Mean Change From Baseline in Beta-cell Function at Week 26 | 4.18 percentage point | Standard Error 3.79 |
Secondary
Mean Change From Baseline in Beta-cell Function at Week 52
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Beta-cell Function at Week 52 | 22.58 percentage point | Standard Error 3.31 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Beta-cell Function at Week 52 | 25.76 percentage point | Standard Error 3.25 |
| Sita -> Sita | Mean Change From Baseline in Beta-cell Function at Week 52 | 3.98 percentage point | Standard Error 3.3 |
Secondary
Mean Change From Baseline in Body Weight at Week 26
Calculated as an estimate of the mean change from baseline in body weight at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Body Weight at Week 26 | -2.86 kg | Standard Error 0.27 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Body Weight at Week 26 | -3.38 kg | Standard Error 0.27 |
| Sita -> Sita | Mean Change From Baseline in Body Weight at Week 26 | -0.96 kg | Standard Error 0.27 |
Secondary
Mean Change From Baseline in Body Weight at Week 52
Calculated as an estimate of the mean change from baseline in body weight at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Body Weight at Week 52 | -2.78 kg | Standard Error 0.31 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Body Weight at Week 52 | -3.68 kg | Standard Error 0.31 |
| Sita -> Sita | Mean Change From Baseline in Body Weight at Week 52 | -1.16 kg | Standard Error 0.31 |
Secondary
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 | -0.71 mmHg | Standard Error 0.6 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 | 0.07 mmHg | Standard Error 0.59 |
| Sita -> Sita | Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26 | -1.78 mmHg | Standard Error 0.6 |
Secondary
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52 | -0.53 mmHg | Standard Error 0.57 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52 | -0.87 mmHg | Standard Error 0.57 |
| Sita -> Sita | Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52 | -1.47 mmHg | Standard Error 0.57 |
Secondary
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | -1.87 mmol/L | Standard Error 0.15 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | -2.14 mmol/L | Standard Error 0.15 |
| Sita -> Sita | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 | -0.83 mmol/L | Standard Error 0.15 |
Secondary
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | -1.71 mmol/L | Standard Error 0.17 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | -2.04 mmol/L | Standard Error 0.17 |
| Sita -> Sita | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | -0.59 mmol/L | Standard Error 0.17 |
Secondary
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.
Time frame: Week 0, Week 78
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78 | -1.30 mmol/L | Standard Error 0.18 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78 | -1.65 mmol/L | Standard Error 0.18 |
Secondary
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26 | -0.03 mmol/L | Standard Error 0.02 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26 | -0.07 mmol/L | Standard Error 0.02 |
| Sita -> Sita | Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26 | -0.05 mmol/L | Standard Error 0.02 |
Secondary
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52 | -0.07 mmol/L | Standard Error 0.02 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52 | -0.10 mmol/L | Standard Error 0.02 |
| Sita -> Sita | Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52 | -0.06 mmol/L | Standard Error 0.02 |
Secondary
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26 | 0.00 mmol/L | Standard Error 0.01 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26 | 0.00 mmol/L | Standard Error 0.01 |
| Sita -> Sita | Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26 | 0.00 mmol/L | Standard Error 0.01 |
Secondary
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52 | 0.01 mmol/L | Standard Error 0.01 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52 | 0.02 mmol/L | Standard Error 0.01 |
| Sita -> Sita | Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52 | 0.01 mmol/L | Standard Error 0.01 |
Secondary
Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26 | -1.02 mg/L | Standard Error 0.31 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26 | -0.99 mg/L | Standard Error 0.31 |
| Sita -> Sita | Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26 | -0.66 mg/L | Standard Error 0.31 |
Secondary
Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.
Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26. | -1.70 pg/mL | Standard Error 2.49 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26. | 1.71 pg/mL | Standard Error 2.47 |
| Sita -> Sita | Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26. | 0.91 pg/mL | Standard Error 2.49 |
Secondary
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26 | 0.08 mmol/L | Standard Error 0.05 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26 | 0.05 mmol/L | Standard Error 0.05 |
| Sita -> Sita | Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26 | 0.13 mmol/L | Standard Error 0.05 |
Secondary
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52 | 0.09 mmol/L | Standard Error 0.05 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52 | 0.09 mmol/L | Standard Error 0.05 |
| Sita -> Sita | Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52 | 0.17 mmol/L | Standard Error 0.05 |
Secondary
Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. | 5.19 pmol/L | Standard Error 2.07 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. | 3.74 pmol/L | Standard Error 2.06 |
| Sita -> Sita | Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26. | 3.71 pmol/L | Standard Error 2.07 |
Secondary
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time frame: Week 0, Week 26
Population: Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26 | 3.51 scores on a scale | Standard Error 0.49 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26 | 4.35 scores on a scale | Standard Error 0.48 |
| Sita -> Sita | Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26 | 2.96 scores on a scale | Standard Error 0.48 |
Secondary
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time frame: Week 0, Week 52
Population: Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52 | 3.32 scores on a scale | Standard Error 0.49 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52 | 4.31 scores on a scale | Standard Error 0.48 |
| Sita -> Sita | Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52 | 2.96 scores on a scale | Standard Error 0.48 |
Secondary
Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.
Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26. | -833 U/L | Standard Error 945.1 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26. | -561 U/L | Standard Error 941.1 |
| Sita -> Sita | Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26. | 586 U/L | Standard Error 952 |
Secondary
Mean Change From Baseline in Pulse at Week 26
Calculated as an estimate of the mean change from baseline in pulse at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Pulse at Week 26 | 2.32 beats/minute | Standard Error 0.59 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Pulse at Week 26 | 3.94 beats/minute | Standard Error 0.58 |
| Sita -> Sita | Mean Change From Baseline in Pulse at Week 26 | -0.64 beats/minute | Standard Error 0.59 |
Secondary
Mean Change From Baseline in Pulse at Week 52
Calculated as an estimate of the mean change from baseline in pulse at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Pulse at Week 52 | 1.72 mmHg | Standard Error 0.6 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Pulse at Week 52 | 3.09 mmHg | Standard Error 0.6 |
| Sita -> Sita | Mean Change From Baseline in Pulse at Week 52 | 0.09 mmHg | Standard Error 0.6 |
Secondary
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 | -0.55 mmHg | Standard Error 0.89 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 | -0.72 mmHg | Standard Error 0.89 |
| Sita -> Sita | Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26 | -0.94 mmHg | Standard Error 0.89 |
Secondary
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 | -0.37 mmHg | Standard Error 0.93 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 | -2.55 mmHg | Standard Error 0.93 |
| Sita -> Sita | Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52 | -1.03 mmHg | Standard Error 0.93 |
Secondary
Mean Change From Baseline in Total Cholesterol at Week 26
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Total Cholesterol at Week 26 | -0.03 mmol/L | Standard Error 0.06 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Total Cholesterol at Week 26 | -0.17 mmol/L | Standard Error 0.05 |
| Sita -> Sita | Mean Change From Baseline in Total Cholesterol at Week 26 | -0.02 mmol/L | Standard Error 0.05 |
Secondary
Mean Change From Baseline in Total Cholesterol at Week 52
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Total Cholesterol at Week 52 | -0.01 mmol/L | Standard Error 0.06 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Total Cholesterol at Week 52 | -0.09 mmol/L | Standard Error 0.06 |
| Sita -> Sita | Mean Change From Baseline in Total Cholesterol at Week 52 | 0.03 mmol/L | Standard Error 0.06 |
Secondary
Mean Change From Baseline in Triglycerides (TG) at Week 26
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Triglycerides (TG) at Week 26 | -0.19 mmol/L | Standard Error 0.1 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Triglycerides (TG) at Week 26 | -0.43 mmol/L | Standard Error 0.09 |
| Sita -> Sita | Mean Change From Baseline in Triglycerides (TG) at Week 26 | -0.40 mmol/L | Standard Error 0.09 |
Secondary
Mean Change From Baseline in Triglycerides (TG) at Week 52
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Triglycerides (TG) at Week 52 | -0.10 mmol/L | Standard Error 0.1 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Triglycerides (TG) at Week 52 | -0.32 mmol/L | Standard Error 0.1 |
| Sita -> Sita | Mean Change From Baseline in Triglycerides (TG) at Week 52 | -0.23 mmol/L | Standard Error 0.1 |
Secondary
Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. | -0.55 pg/mL | Standard Error 0.25 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. | -0.74 pg/mL | Standard Error 0.25 |
| Sita -> Sita | Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26. | -0.53 pg/mL | Standard Error 0.25 |
Secondary
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26 | -0.11 mmol/L | Standard Error 0.03 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26 | -0.20 mmol/L | Standard Error 0.03 |
| Sita -> Sita | Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26 | -0.15 mmol/L | Standard Error 0.03 |
Secondary
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 | -0.11 mmol/L | Standard Error 0.04 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 | -0.19 mmol/L | Standard Error 0.04 |
| Sita -> Sita | Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 | -0.15 mmol/L | Standard Error 0.04 |
Secondary
Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.
Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26. | -1.73 percentage point | Standard Error 2.77 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26. | -4.34 percentage point | Standard Error 2.76 |
| Sita -> Sita | Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26. | -1.8 percentage point | Standard Error 2.82 |
Secondary
Mean Change From Baseline in Waist Circumference at Week 26.
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Waist Circumference at Week 26. | -2.69 cm | Standard Error 0.35 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Waist Circumference at Week 26. | -2.63 cm | Standard Error 0.36 |
| Sita -> Sita | Mean Change From Baseline in Waist Circumference at Week 26. | -1.12 cm | Standard Error 0.36 |
Secondary
Mean Change From Baseline in Waist Circumference at Week 52
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Waist Circumference at Week 52 | -2.36 participants | Standard Error 0.38 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Waist Circumference at Week 52 | -3.02 participants | Standard Error 0.38 |
| Sita -> Sita | Mean Change From Baseline in Waist Circumference at Week 52 | -1.23 participants | Standard Error 0.38 |
Secondary
Mean Change From Baseline in Waist to Hip Ratio at Week 26.
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Waist to Hip Ratio at Week 26. | -0.01 cm/cm | Standard Error 0 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Waist to Hip Ratio at Week 26. | -0.01 cm/cm | Standard Error 0 |
| Sita -> Sita | Mean Change From Baseline in Waist to Hip Ratio at Week 26. | -0.00 cm/cm | Standard Error 0 |
Secondary
Mean Change From Baseline in Waist to Hip Ratio at Week 52
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Mean Change From Baseline in Waist to Hip Ratio at Week 52 | -0.00 cm/cm | Standard Error 0 |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Mean Change From Baseline in Waist to Hip Ratio at Week 52 | -0.01 cm/cm | Standard Error 0 |
| Sita -> Sita | Mean Change From Baseline in Waist to Hip Ratio at Week 52 | -0.00 cm/cm | Standard Error 0 |
Secondary
Mean Change in Apolipoprotein B From Week 52 to Week 78
Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Apolipoprotein B From Week 52 to Week 78 | 0.23 mmol/L | Standard Deviation 0.4 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Apolipoprotein B From Week 52 to Week 78 | 0.17 mmol/L | Standard Deviation 0.4 |
Secondary
Mean Change in Beta-cell Function From Week 52 to Week 78
Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Beta-cell Function From Week 52 to Week 78 | 13.31 percentage point | Standard Deviation 29.4 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Beta-cell Function From Week 52 to Week 78 | 23.09 percentage point | Standard Deviation 43.7 |
Secondary
Mean Change in Body Weight From Week 52 to Week 78
Mean change in body weight from Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Body Weight From Week 52 to Week 78 | -1.64 kg | Standard Deviation 3 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Body Weight From Week 52 to Week 78 | -2.48 kg | Standard Deviation 3.6 |
Secondary
Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78
Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78 | -0.60 mmHg | Standard Deviation 10 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78 | 0.03 mmHg | Standard Deviation 8.9 |
Secondary
Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78 | -0.84 mmol/L | Standard Deviation 1.8 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78 | -1.42 mmol/L | Standard Deviation 2.1 |
Secondary
Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
Mean change in free fatty acids (FFA) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78 | 0.02 mmol/L | Standard Deviation 0.3 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78 | -0.01 mmol/L | Standard Deviation 0.3 |
Secondary
Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78 | 0.02 mmol/L | Standard Deviation 0.1 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78 | -0.01 mmol/L | Standard Deviation 0.2 |
Secondary
Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78 | -0.22 mmol/L | Standard Deviation 0.7 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78 | -0.25 mmol/L | Standard Deviation 0.6 |
Secondary
Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time frame: Week 52, Week 78
Population: Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78 | 1.48 scores on a scale | Standard Deviation 4.4 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78 | 0.98 scores on a scale | Standard Deviation 6.1 |
Secondary
Mean Change in Pulse From Week 52 to Week 78
Mean change in pulse from Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Pulse From Week 52 to Week 78 | 0.90 beats/minute | Standard Deviation 8.4 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Pulse From Week 52 to Week 78 | 2.19 beats/minute | Standard Deviation 7.7 |
Secondary
Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78
Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78 | -2.12 mmHg | Standard Deviation 14.6 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78 | 0.35 mmHg | Standard Deviation 12.4 |
Secondary
Mean Change in Total Cholesterol From Week 52 to Week 78
Mean change in total cholesterol from Week 52 to Week 78
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Total Cholesterol From Week 52 to Week 78 | -0.16 mmol/L | Standard Deviation 0.8 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Total Cholesterol From Week 52 to Week 78 | -0.24 mmol/L | Standard Deviation 0.7 |
Secondary
Mean Change in Triglycerides (TG) From Week 52 to Week 78
Mean change in triglycerides (TG) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Triglycerides (TG) From Week 52 to Week 78 | -0.20 mmol/L | Standard Deviation 0.8 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Triglycerides (TG) From Week 52 to Week 78 | -0.26 mmol/L | Standard Deviation 0.8 |
Secondary
Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78 | 0.03 mmol/L | Standard Deviation 0.3 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78 | 0.02 mmol/L | Standard Deviation 0.3 |
Secondary
Mean Change in Waist Circumference From Week 52 to Week 78
Mean change in Waist Circumference from Week 52 to Week 78.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Waist Circumference From Week 52 to Week 78 | -1.33 kg | Standard Deviation 3.5 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Waist Circumference From Week 52 to Week 78 | -2.05 kg | Standard Deviation 4.1 |
Secondary
Mean Change in Waist to Hip Ratio From Week 52 to Week 78
Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time frame: Week 52, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Mean Change in Waist to Hip Ratio From Week 52 to Week 78 | -0.01 cm/cm | Standard Deviation 0 |
| Sita -> Sita -> Lira 1.8 mg | Mean Change in Waist to Hip Ratio From Week 52 to Week 78 | -0.00 cm/cm | Standard Deviation 0 |
Secondary
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
Calculated as the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 26
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26 | 23 percentage of subjects |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26 | 36 percentage of subjects |
| Sita -> Sita | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26 | 12 percentage of subjects |
Secondary
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 52
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52 | 24 percentage of subjects |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52 | 40 percentage of subjects |
| Sita -> Sita | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52 | 17 percentage of subjects |
Secondary
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the FAS.
Time frame: Week 0, Week 78
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 | 12 percentage of subjects |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 | 27 percentage of subjects |
Secondary
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the extension 2 FAS.
Time frame: Week 0, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 | 29 percentage of subjects |
| Sita -> Sita -> Lira 1.8 mg | Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78 | 25 percentage of subjects |
Secondary
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26
Time frame: Week 0, Week 26
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26 | 43 percentage of subjects |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26 | 55 percentage of subjects |
| Sita -> Sita | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26 | 22 percentage of subjects |
Secondary
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 52
Time frame: Week 0, Week 52
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52 | 50 percentage of subjects |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52 | 63 percentage of subjects |
| Sita -> Sita | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52 | 27 percentage of subjects |
Secondary
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the extension 2 FAS.
Time frame: Week 0, Week 78
Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sita -> Sita -> Lira 1.2 mg | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 | 49 percentage of subjects |
| Sita -> Sita -> Lira 1.8 mg | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 | 50 percentage of subjects |
Secondary
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the FAS.
Time frame: Week 0, Week 78
Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 | 35 percentage of subjects |
| Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg | Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78 | 51 percentage of subjects |