Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.
Interventions
DRUGliraglutide
1.8 mg once daily for s.c. (under the skin) injection.
DRUGexenatide
10 mcg twice daily for s.c. (under the skin) injection.
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 * Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator * HbA1C equal to or greater than 7.0% and equal to or lower than 11.0% * Body Mass Index (BMI) equal to or lower than 45.0 kg/m2
Exclusion criteria
* Previous treatment with insulin * Treatment with any anti-diabetic drug other than metformin and sulphonylurea * Any previous exposure to exenatide or liraglutide * Impaired liver or/and renal function * History of any significant cardiac events * Known retinopathy or maculopathy requiring acute treatment * Recurrent major hypoglycaemia or hypoglycaemic unawareness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated A1c (HbA1c) at Week 26 | week 0, week 26 | Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated A1c (HbA1c) at Week 78 | week 0, week 78 | Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group) |
| Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26 | week 0, week 26 | Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation) |
| Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78 | week 0, week 78 | Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment) |
| Change in Body Weight at Week 26 | week 0, week 26 | Change in body weight from baseline (week 0) to 26 weeks (end of randomisation) |
| Change in Body Weight, Weeks 26-78 | week 26, week 78 | Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group) |
| Change in Body Weight at Week 78 | week 0, week 78 | Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group) |
| Change in Fasting Plasma Glucose at Week 26 | week 0, week 26 | Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation) |
| Change in Fasting Plasma Glucose, Weeks 26-78 | week 26, week 78 | Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group) |
| Change in Fasting Plasma Glucose at Week 78 | week 0, week 78 | Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group) |
| Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26 | week 0, week 26 | Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast. |
| Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26 | week 0, week 26 | Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. |
| Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26 | week 0, week 26 | Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. |
| Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 | week 26, week 78 | Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. |
| Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78 | week 26, week 78 | Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch. |
| Change in High-density Lipoprotein-cholesterol at Week 26 | week 0, week 26 | Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation) |
| Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78 | week 26, week 78 | Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. |
| Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78 | week 0, week 78 | Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. |
| Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78 | week 0, week 78 | Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. |
| Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78 | week 0, week 78 | Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. |
| Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26 | week 0, week 26 | Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. |
| Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26 | week 0. week 26 | Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. |
| Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26 | week 0, week 26 | Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. |
| Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 | week 26, week 78 | Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. |
| Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78 | week 26, week 78 | Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. |
| Change in High-density Lipoprotein-cholesterol, Weeks 26-78 | week 26, week 78 | Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78 | week 26, week 78 | Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. |
| Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78 | week 0, week 78 | Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast. |
| Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78 | week 0, week 78 | Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch. |
| Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78 | week 0, week 78 | Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner. |
| Change in Beta-cell Function at Week 26 | week 0, week 26 | Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5). |
| Change in Beta-cell Function, Weeks 26-78 | week 26, week 78 | Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5). |
| Change in Beta-cell Function at Week 78 | week 0, week 78 | Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5). |
| Change in Total Cholesterol at Week 26 | week 0, week 26 | Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation) |
| Change in Total Cholesterol, Weeks 26-78 | week 26, week 78 | Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Total Cholesterol at Week 78 | week 0, week 78 | Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Low-density Lipoprotein-cholesterol at Week 26 | week 0, week 26 | Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation) |
| Change in Low-density Lipoprotein-cholesterol, Weeks 26-78 | week 26, week 78 | Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Low-density Lipoprotein-cholesterol at Week 78 | week 0, week 78 | Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Very Low-density Lipoprotein-cholesterol at Week 26 | week 0, week 26 | Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation) |
| Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78 | week 26, week 78 | Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Very Low-density Lipoprotein-cholesterol at Week 78 | week 0, week 78 | Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in High-density Lipoprotein-cholesterol at Week 78 | week 0, week 78 | Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Triglyceride at Week 26 | week 0, week 26 | Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation) |
| Change in Triglyceride, Weeks 26-78 | week 26, week 78 | Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Triglyceride at Week 78 | week 0, week 78 | Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Free Fatty Acid at Week 26 | week 0, week 26 | Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation) |
| Change in Free Fatty Acid, Weeks 26-78 | week 26, week 78 | Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Glycosylated A1c (HbA1c), Weeks 26-78 | week 26, week 78 | Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group) |
| Change in Apolipoprotein B at Week 26 | week 0, week 26 | Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation) |
| Change in Apolipoprotein B, Weeks 26-78 | week 26, week 78 | Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Change in Apolipoprotein B at Week 78 | week 0, week 78 | Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
| Hypoglycaemic Episodes at Week 26 | weeks 0-26 | Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. |
| Hypoglyceamic Episodes, Weeks 26-78 | weeks 26-78 | Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. |
| Change in Free Fatty Acid at Week 78 | week 0, week 78 | Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group). |
Countries
Austria, Denmark, Finland, France, Germany, Ireland, North Macedonia, Norway, Poland, Puerto Rico, Romania, Slovenia, Spain, Sweden, Switzerland, United States
Participant flow
Recruitment details
A total of 133 centres in 15 countries: Austria (4), Denmark (6), Finland (5), France (5), Germany (14), Ireland (4), Macedonia (1), Norway (4), Poland (9), Romania (3), Slovenia (3), Spain (4), Sweden (2), Switzerland (4) and United States (65).
Pre-assignment details
Eligible subjects were subjects with type 2 diabetes being treated with oral anti-diabetic (OAD) therapy(ies) for at least 3 months prior to the study. Three subjects were exposed to study drug prior to randomisation, and thus only included in safety analysis set.
Participants by arm
| Arm | Count |
|---|---|
| Liraglutide -> Liraglutide -> Liraglutide Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | 233 |
| Exenatide -> Liraglutide -> Liraglutide Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78) | 231 |
| Total | 464 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-Blind, Week 0-26 | Adverse Event | 23 | 31 |
| Double-Blind, Week 0-26 | Fear of hypoglycaemia | 0 | 1 |
| Double-Blind, Week 0-26 | Hypoglycaemia | 0 | 2 |
| Double-Blind, Week 0-26 | Lack of Efficacy | 1 | 0 |
| Double-Blind, Week 0-26 | Loss of trust | 0 | 1 |
| Double-Blind, Week 0-26 | Lost to follow up | 2 | 1 |
| Double-Blind, Week 0-26 | Mutual consent | 0 | 1 |
| Double-Blind, Week 0-26 | Protocol Violation | 4 | 3 |
| Double-Blind, Week 0-26 | Subject decision | 1 | 1 |
| Double-Blind, Week 0-26 | Withdrawal criteria | 1 | 1 |
| Double-Blind, Week 0-26 | Withdrawal of consent | 1 | 3 |
| Open-Label Extension, Week 26-78 | Adverse Event | 3 | 9 |
| Open-Label Extension, Week 26-78 | Change in treatment | 1 | 1 |
| Open-Label Extension, Week 26-78 | Completed extension 1 (weeks 26-40) | 18 | 25 |
| Open-Label Extension, Week 26-78 | Consent withdrawn | 2 | 1 |
| Open-Label Extension, Week 26-78 | Creatine increased | 1 | 0 |
| Open-Label Extension, Week 26-78 | Decreased kidney function | 1 | 0 |
| Open-Label Extension, Week 26-78 | Exclusion criteria | 2 | 0 |
| Open-Label Extension, Week 26-78 | Hypoglycaemia | 0 | 1 |
| Open-Label Extension, Week 26-78 | Lack of Efficacy | 6 | 5 |
| Open-Label Extension, Week 26-78 | Lost to follow up | 1 | 1 |
| Open-Label Extension, Week 26-78 | Protocol Violation | 3 | 4 |
| Open-Label Extension, Week 26-78 | Subject decision | 2 | 0 |
| Open-Label Extension, Week 26-78 | Withdrawel criteria | 1 | 2 |
Baseline characteristics
| Characteristic | Liraglutide -> Liraglutide -> Liraglutide | Total | Exenatide -> Liraglutide -> Liraglutide |
|---|---|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 9.8 | 56.7 years STANDARD_DEVIATION 10.3 | 57.1 years STANDARD_DEVIATION 10.8 |
| BMI | 32.9 kg/m2 STANDARD_DEVIATION 5.5 | 32.9 kg/m2 STANDARD_DEVIATION 5.6 | 32.9 kg/m2 STANDARD_DEVIATION 5.7 |
| Duration of diabetes | 8.5 years STANDARD_DEVIATION 6.2 | 8.2 years STANDARD_DEVIATION 6 | 7.9 years STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 57 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 201 Participants | 407 Participants | 206 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HbA1c | 8.4 percentage of total haemoglobin STANDARD_DEVIATION 1 | 8.3 percentage of total haemoglobin STANDARD_DEVIATION 1 | 8.2 percentage of total haemoglobin STANDARD_DEVIATION 1 |
| Height | 1.68 m STANDARD_DEVIATION 0.1 | 1.68 m STANDARD_DEVIATION 0.1 | 1.68 m STANDARD_DEVIATION 0.1 |
| Previous OAD treatment Metformin | 64 participants | 127 participants | 63 participants |
| Previous OAD treatment Metformin/Sulphonylurea Combination | 145 participants | 292 participants | 147 participants |
| Previous OAD treatment Sulphonylurea | 24 participants | 45 participants | 21 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 25 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 216 Participants | 426 Participants | 210 Participants |
| Sex: Female, Male Female | 119 Participants | 223 Participants | 104 Participants |
| Sex: Female, Male Male | 114 Participants | 241 Participants | 127 Participants |
| Weight | 93.1 kg STANDARD_DEVIATION 20.1 | 93.1 kg STANDARD_DEVIATION 19.8 | 93.0 kg STANDARD_DEVIATION 19.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 162 / 235 | 167 / 232 |
| serious Total, serious adverse events | 23 / 235 | 23 / 232 |
Outcome results
Primary
Change in Glycosylated A1c (HbA1c) at Week 26
Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Glycosylated A1c (HbA1c) at Week 26 | -1.12 percentage point of total HbA1c | Standard Error 0.08 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Glycosylated A1c (HbA1c) at Week 26 | -0.79 percentage point of total HbA1c | Standard Error 0.08 |
Comparison: ANCOVA with treatment, country and previous OAD treatment as fixed effects and baseline HbA1c as covariate.~2 hypotheses were tested: H01: µliraglutide ≥ µexenatide + Δ, HA1: µliraglutide \< µexenatide + Δ; Δ=0.4%. If non-inferiority was concluded, a test for superiority was established by a 1-sided test of the hypothesis H02: µliraglutide ≥ µexenatide against HA2: µliraglutide \< µexenatide. Superiority was concluded if the upper limit of the 2-sided 95% CI for the difference was below 0%.p-value: <0.000195% CI: [-0.47, -0.18]ANCOVA
Secondary
Change in Apolipoprotein B at Week 26
Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Apolipoprotein B at Week 26 | -0.06 g/L | Standard Error 0.02 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Apolipoprotein B at Week 26 | -0.03 g/L | Standard Error 0.02 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.111995% CI: [-0.05, 0.01]ANCOVA
Secondary
Change in Apolipoprotein B at Week 78
Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Apolipoprotein B at Week 78 | -0.08 g/L | Standard Deviation 0.176 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Apolipoprotein B at Week 78 | -0.07 g/L | Standard Deviation 0.192 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-0.105, -0.056]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-0.094, -0.038]Paired t test
Secondary
Change in Apolipoprotein B, Weeks 26-78
Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Apolipoprotein B, Weeks 26-78 | -0.02 g/L | Standard Deviation 0.168 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Apolipoprotein B, Weeks 26-78 | -0.03 g/L | Standard Deviation 0.189 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.134295% CI: [-0.041, 0.006]Paired t test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.034495% CI: [-0.057, -0.002]Paired t test
Secondary
Change in Beta-cell Function at Week 26
Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5).
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Beta-cell Function at Week 26 | 32.12 percentage point (%point) | Standard Error 6.75 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Beta-cell Function at Week 26 | 2.74 percentage point (%point) | Standard Error 6.75 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: <0.000195% CI: [16.81, 41.93]ANCOVA
Secondary
Change in Beta-cell Function at Week 78
Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5).
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Beta-cell Function at Week 78 | 24.86 percentage point (%point) | Standard Deviation 59.326 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Beta-cell Function at Week 78 | 11.13 percentage point (%point) | Standard Deviation 87.145 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [16.348, 33.374]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.09295% CI: [-1.835, 24.093]Paired t test
Secondary
Change in Beta-cell Function, Weeks 26-78
Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5).
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Beta-cell Function, Weeks 26-78 | -18.18 percentage point (%point) | Standard Deviation 62.811 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Beta-cell Function, Weeks 26-78 | 2.29 percentage point (%point) | Standard Deviation 52.997 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-26.988, -9.382]Paired t test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.530495% CI: [-5.327, 10.307]Paired t test
Secondary
Change in Body Weight at Week 26
Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Body Weight at Week 26 | -3.24 kg | Standard Error 0.33 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Body Weight at Week 26 | -2.87 kg | Standard Error 0.33 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline body weight as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the body weight in the liraglutide arm and exenatide arm, respectively.p-value: 0.223595% CI: [-0.99, 0.23]ANCOVA
Secondary
Change in Body Weight at Week 78
Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Body Weight at Week 78 | -3.3 kg | Standard Deviation 4.63 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Body Weight at Week 78 | -3.2 kg | Standard Deviation 4.44 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-3.9, -2.61]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-3.85, -2.55]Paired t test
Secondary
Change in Body Weight, Weeks 26-78
Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Body Weight, Weeks 26-78 | -0.4 kg | Standard Deviation 3.24 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Body Weight, Weeks 26-78 | -0.7 kg | Standard Deviation 3.67 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.079395% CI: [-0.86, 0.05]Paired t test
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.007595% CI: [-1.26, -0.2]Paired t test
Secondary
Change in Fasting Plasma Glucose at Week 26
Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Fasting Plasma Glucose at Week 26 | -1.61 mmol/L | Standard Error 0.2 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Fasting Plasma Glucose at Week 26 | -0.60 mmol/L | Standard Error 0.2 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline fasting plasma glucose as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the fasting plasma glucose in the liraglutide and exenatide arm, respectively.p-value: <0.000195% CI: [-1.37, -0.65]ANCOVA
Secondary
Change in Fasting Plasma Glucose at Week 78
Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Fasting Plasma Glucose at Week 78 | -1.3 mmol/L | Standard Deviation 2.5 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Fasting Plasma Glucose at Week 78 | -0.8 mmol/L | Standard Deviation 2.76 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-1.62, -0.92]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-1.23, -0.42]Paired t test
Secondary
Change in Fasting Plasma Glucose, Weeks 26-78
Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Fasting Plasma Glucose, Weeks 26-78 | 0.7 mmol/L | Standard Deviation 1.84 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Fasting Plasma Glucose, Weeks 26-78 | -0.1 mmol/L | Standard Deviation 2.42 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78- µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [0.48, 1]Paired t test
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.486495% CI: [-0.48, 0.23]Paired t test
Secondary
Change in Free Fatty Acid at Week 26
Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Free Fatty Acid at Week 26 | -0.17 mmol/L | Standard Error 0.02 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Free Fatty Acid at Week 26 | -0.10 mmol/L | Standard Error 0.02 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.001495% CI: [-0.11, -0.03]ANCOVA
Secondary
Change in Free Fatty Acid at Week 78
Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Free Fatty Acid at Week 78 | -0.10 mmol/L | Standard Deviation 0.273 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Free Fatty Acid at Week 78 | -0.07 mmol/L | Standard Deviation 0.302 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-0.14, -0.062]Paired t test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.001295% CI: [-0.118, -0.03]Paired t test
Secondary
Change in Free Fatty Acid, Weeks 26-78
Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Free Fatty Acid, Weeks 26-78 | 0.06 mmol/L | Standard Deviation 0.269 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Free Fatty Acid, Weeks 26-78 | 0.01 mmol/L | Standard Deviation 0.272 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.001895% CI: [0.023, 0.098]Paired t test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.549995% CI: [-0.028, 0.052]Paired t test
Secondary
Change in Glycosylated A1c (HbA1c) at Week 78
Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Glycosylated A1c (HbA1c) at Week 78 | -0.98 percentage point of total HbA1c | Standard Deviation 1.119 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Glycosylated A1c (HbA1c) at Week 78 | -0.85 percentage point of total HbA1c | Standard Deviation 1.105 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-1.137, -0.823]Paired t-test
Comparison: The analysis was made with a paired t test within the exenatide→liraglutide group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-1.01, -0.687]Paired t-test
Secondary
Change in Glycosylated A1c (HbA1c), Weeks 26-78
Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Glycosylated A1c (HbA1c), Weeks 26-78 | 0.25 percentage point of total HbA1c | Standard Deviation 0.803 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Glycosylated A1c (HbA1c), Weeks 26-78 | -0.00 percentage point of total HbA1c | Standard Deviation 0.924 |
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [0.139, 0.364]Paired t-test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.987295% CI: [-1.36, 0.134]Paired t-test
Secondary
Change in High-density Lipoprotein-cholesterol at Week 26
Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in High-density Lipoprotein-cholesterol at Week 26 | -0.04 mmol/L | Standard Error 0.02 |
| Exenatide -> Liraglutide -> Liraglutide | Change in High-density Lipoprotein-cholesterol at Week 26 | -0.05 mmol/L | Standard Error 0.02 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.510595% CI: [-0.02, 0.04]ANCOVA
Secondary
Change in High-density Lipoprotein-cholesterol at Week 78
Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in High-density Lipoprotein-cholesterol at Week 78 | -0.03 mmol/L | Standard Deviation 0.159 |
| Exenatide -> Liraglutide -> Liraglutide | Change in High-density Lipoprotein-cholesterol at Week 78 | -0.02 mmol/L | Standard Deviation 0.165 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.025495% CI: [-0.05, -0.003]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.224495% CI: [-0.04, 0.009]Paired t test
Secondary
Change in High-density Lipoprotein-cholesterol, Weeks 26-78
Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in High-density Lipoprotein-cholesterol, Weeks 26-78 | -0.01 mmol/L | Standard Deviation 0.15 |
| Exenatide -> Liraglutide -> Liraglutide | Change in High-density Lipoprotein-cholesterol, Weeks 26-78 | 0.00 mmol/L | Standard Deviation 0.141 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.22295% CI: [-0.034, 0.008]Paired t test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.792395% CI: [-0.018, 0.024]Paired t test
Secondary
Change in Low-density Lipoprotein-cholesterol at Week 26
Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Low-density Lipoprotein-cholesterol at Week 26 | -0.44 mmol/L | Standard Error 0.06 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Low-density Lipoprotein-cholesterol at Week 26 | -0.40 mmol/L | Standard Error 0.06 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.441295% CI: [-0.15, 0.06]ANCOVA
Secondary
Change in Low-density Lipoprotein-cholesterol at Week 78
Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Low-density Lipoprotein-cholesterol at Week 78 | -0.30 mmol/L | Standard Deviation 0.604 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Low-density Lipoprotein-cholesterol at Week 78 | -0.21 mmol/L | Standard Deviation 0.647 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-0.39, -0.214]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-0.303, -0.11]Paired t test
Secondary
Change in Low-density Lipoprotein-cholesterol, Weeks 26-78
Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Low-density Lipoprotein-cholesterol, Weeks 26-78 | 0.03 mmol/L | Standard Deviation 0.606 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Low-density Lipoprotein-cholesterol, Weeks 26-78 | 0.08 mmol/L | Standard Deviation 0.72 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.474695% CI: [-0.054, 0.115]Paired t test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.128195% CI: [-0.024, 0.188]Paired t test
Secondary
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26
Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26 | -3.20 mmol/L | Standard Error 0.31 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26 | -3.93 mmol/L | Standard Error 0.3 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.012495% CI: [0.16, 1.31]ANCOVA
Secondary
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78
Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78 | -3.31 mmol/L | Standard Deviation 3.857 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78 | -3.13 mmol/L | Standard Deviation 3.56 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-3.861, -2.763]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-3.673, -2.589]Paired t test
Secondary
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 | 0.06 mmol/L | Standard Deviation 2.827 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 | 0.72 mmol/L | Standard Deviation 3.27 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.7795% CI: [-0.344, 0.463]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.004295% CI: [0.23, 1.212]Paired t test
Secondary
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26
Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26 | -3.05 mmol/L | Standard Error 0.28 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26 | -3.59 mmol/L | Standard Error 0.27 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.03895% CI: [0.03, 1.05]ANCOVA
Secondary
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78
Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78 | -2.21 mmol/L | Standard Deviation 3.752 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78 | -2.55 mmol/L | Standard Deviation 3.625 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-2.747, -1.676]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-3.104, -1.997]Paired t test
Secondary
Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78 | 0.32 mmol/L | Standard Deviation 2.705 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78 | 0.58 mmol/L | Standard Deviation 3.114 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.104195% CI: [-0.066, 0.706]Paired t test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.015195% CI: [0.114, 1.052]Paired t test
Secondary
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26
Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Time frame: week 0. week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26 | -2.74 mmol/L | Standard Error 0.28 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26 | -2.35 mmol/L | Standard Error 0.28 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.14395% CI: [-0.91, 0.13]ANCOVA
Secondary
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78
Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78 | -1.93 mmol/L | Standard Deviation 3.703 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78 | -2.17 mmol/L | Standard Deviation 3.654 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-2.457, -1.403]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-2.731, -1.618]Paired t test
Secondary
Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78 | 0.67 mmol/L | Standard Deviation 3.041 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78 | -0.09 mmol/L | Standard Deviation 2.989 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.002695% CI: [0.238, 1.106]Paired t test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.684595% CI: [-0.541, 0.356]Paired t test
Secondary
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26
Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26 | -0.83 mmol/L | Standard Error 0.28 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26 | -2.16 mmol/L | Standard Error 0.28 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: <0.000195% CI: [0.8, 1.86]ANCOVA
Secondary
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78
Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78 | -1.08 mmol/L | Standard Deviation 3.662 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78 | -0.99 mmol/L | Standard Deviation 3.467 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [-1.605, -0.562]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.000395% CI: [-1.517, -0.458]Paired t test
Secondary
Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78
Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 | -0.22 mmol/L | Standard Deviation 2.866 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78 | 1.15 mmol/L | Standard Deviation 3.253 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.297295% CI: [-0.626, 0.192]Paired t test
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [0.66, 1.637]Paired t test
Secondary
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26
Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26 | -1.10 mmol/L | Standard Error 0.31 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26 | -2.11 mmol/L | Standard Error 0.31 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.000595% CI: [0.44, 1.57]ANCOVA
Secondary
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78
Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78 | -0.35 mmol/L | Standard Deviation 3.975 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78 | -0.95 mmol/L | Standard Deviation 3.23 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.22995% CI: [-0.917, 0.2211]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.000295% CI: [-1.449, -0.459]Paired t test
Secondary
Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78
Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78 | 0.22 mmol/L | Standard Deviation 3.053 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78 | 1.07 mmol/L | Standard Deviation 3.775 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.327195% CI: [-0.219, 0.654]Paired t test
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.000395% CI: [0.497, 1.634]Paired t test
Secondary
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26
Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26 | 0.06 mmol/L | Standard Error 0.28 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26 | 0.06 mmol/L | Standard Error 0.28 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.984995% CI: [-0.52, 0.53]ANCOVA
Secondary
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78
Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78 | 0.26 mmol/L | Standard Deviation 4.158 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78 | -0.37 mmol/L | Standard Deviation 3.838 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.385995% CI: [-0.331, 0.853]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.211995% CI: [-0.956, 0.214]Paired t test
Secondary
Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78
Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78 | 0.05 mmol/L | Standard Deviation 3.307 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78 | -0.09 mmol/L | Standard Deviation 3.419 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.839695% CI: [-0.424, 0.521]Paired t test
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.727895% CI: [-0.604, 0.423]Paired t test
Secondary
Change in Total Cholesterol at Week 26
Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Total Cholesterol at Week 26 | -0.20 mmol/L | Standard Error 0.07 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Total Cholesterol at Week 26 | -0.09 mmol/L | Standard Error 0.07 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.094695% CI: [-0.23, 0.02]ANCOVA
Secondary
Change in Total Cholesterol at Week 78
Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Total Cholesterol at Week 78 | -0.07 mmol/L | Standard Deviation 0.859 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Total Cholesterol at Week 78 | 0.09 mmol/L | Standard Deviation 0.89 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.276495% CI: [-0.187, 0.054]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.191195% CI: [-0.043, 0.216]Paired t test
Secondary
Change in Total Cholesterol, Weeks 26-78
Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the trial products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Total Cholesterol, Weeks 26-78 | 0.11 mmol/L | Standard Deviation 0.774 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Total Cholesterol, Weeks 26-78 | 0.12 mmol/L | Standard Deviation 0.804 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.051395% CI: [-0.001, 0.216]Paired t test
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.051395% CI: [-0.001, 0.233]Paired t test
Secondary
Change in Triglyceride at Week 26
Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Triglyceride at Week 26 | -0.41 mmol/L | Standard Error 0.1 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Triglyceride at Week 26 | -0.23 mmol/L | Standard Error 0.1 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.048595% CI: [-0.37, 0]ANCOVA
Secondary
Change in Triglyceride at Week 78
Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Triglyceride at Week 78 | -0.3 mmol/L | Standard Deviation 1.07 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Triglyceride at Week 78 | -0.1 mmol/L | Standard Deviation 1.47 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.000395% CI: [-0.43, -0.13]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: 0.207895% CI: [-0.35, 0.08]Paired t test
Secondary
Change in Triglyceride, Weeks 26-78
Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Triglyceride, Weeks 26-78 | 0.1 mmol/L | Standard Deviation 0.82 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Triglyceride, Weeks 26-78 | -0.0 mmol/L | Standard Deviation 0.96 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.116195% CI: [-0.02, 0.21]Paired t test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.788895% CI: [-0.16, 0.12]Paired t test
Secondary
Change in Very Low-density Lipoprotein-cholesterol at Week 26
Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Very Low-density Lipoprotein-cholesterol at Week 26 | 0.20 mmol/L | Standard Error 0.04 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Very Low-density Lipoprotein-cholesterol at Week 26 | 0.27 mmol/L | Standard Error 0.04 |
Comparison: ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.p-value: 0.027795% CI: [-0.13, -0.01]ANCOVA
Secondary
Change in Very Low-density Lipoprotein-cholesterol at Week 78
Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Very Low-density Lipoprotein-cholesterol at Week 78 | 0.27 mmol/L | Standard Deviation 0.306 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Very Low-density Lipoprotein-cholesterol at Week 78 | 0.31 mmol/L | Standard Deviation 0.346 |
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [0.223, 0.315]Paired t test
Comparison: The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.p-value: <0.000195% CI: [0.259, 0.364]Paired t test
Secondary
Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78
Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).
Time frame: week 26, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78 | 0.06 mmol/L | Standard Deviation 0.29 |
| Exenatide -> Liraglutide -> Liraglutide | Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78 | 0.03 mmol/L | Standard Deviation 0.307 |
Comparison: A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.00395% CI: [0.021, 0.102]Paired t test
Comparison: A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.p-value: 0.145295% CI: [-0.012, 0.079]Paired t test
Secondary
Hypoglycaemic Episodes at Week 26
Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with 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 subjects who had been exposed to at least one dose of the study products.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Hypoglycaemic Episodes at Week 26 | Major | 0 episodes |
| Liraglutide -> Liraglutide -> Liraglutide | Hypoglycaemic Episodes at Week 26 | Minor | 208 episodes |
| Liraglutide -> Liraglutide -> Liraglutide | Hypoglycaemic Episodes at Week 26 | Symptoms only | 79 episodes |
| Exenatide -> Liraglutide -> Liraglutide | Hypoglycaemic Episodes at Week 26 | Major | 2 episodes |
| Exenatide -> Liraglutide -> Liraglutide | Hypoglycaemic Episodes at Week 26 | Minor | 264 episodes |
| Exenatide -> Liraglutide -> Liraglutide | Hypoglycaemic Episodes at Week 26 | Symptoms only | 93 episodes |
Secondary
Hypoglyceamic Episodes, Weeks 26-78
Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: weeks 26-78
Population: The safety analysis set is all subjects who had been exposed to at least one dose of the study products.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Hypoglyceamic Episodes, Weeks 26-78 | Major | 1 episodes |
| Liraglutide -> Liraglutide -> Liraglutide | Hypoglyceamic Episodes, Weeks 26-78 | Minor | 140 episodes |
| Liraglutide -> Liraglutide -> Liraglutide | Hypoglyceamic Episodes, Weeks 26-78 | Symptoms only | 37 episodes |
| Exenatide -> Liraglutide -> Liraglutide | Hypoglyceamic Episodes, Weeks 26-78 | Minor | 172 episodes |
| Exenatide -> Liraglutide -> Liraglutide | Hypoglyceamic Episodes, Weeks 26-78 | Major | 0 episodes |
| Exenatide -> Liraglutide -> Liraglutide | Hypoglyceamic Episodes, Weeks 26-78 | Symptoms only | 32 episodes |
Secondary
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26
Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)
Time frame: week 0, week 26
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26 | Treatment target HbA1c < 7% | 53 percentage (%) of subjects |
| Liraglutide -> Liraglutide -> Liraglutide | Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26 | Treatment target HbA1c =< 6.5% | 34 percentage (%) of subjects |
| Exenatide -> Liraglutide -> Liraglutide | Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26 | Treatment target HbA1c < 7% | 42 percentage (%) of subjects |
| Exenatide -> Liraglutide -> Liraglutide | Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26 | Treatment target HbA1c =< 6.5% | 20 percentage (%) of subjects |
Secondary
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78
Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)
Time frame: week 0, week 78
Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liraglutide -> Liraglutide -> Liraglutide | Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78 | Treatment target HbA1c < 7% | 47 percentage (%) of subjects |
| Liraglutide -> Liraglutide -> Liraglutide | Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78 | Treatment target HbA1c =< 6.5% | 31 percentage (%) of subjects |
| Exenatide -> Liraglutide -> Liraglutide | Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78 | Treatment target HbA1c < 7% | 48 percentage (%) of subjects |
| Exenatide -> Liraglutide -> Liraglutide | Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78 | Treatment target HbA1c =< 6.5% | 35 percentage (%) of subjects |