To Evaluate the Effect of Liraglutide Versus Glimepiride... | NCT00294723 | Trialant
NCT00294723
Sponsor
Novo Nordisk A/S
Status
Terminated
Last Update Posted
Mar 7, 2017Actual
Enrollment
746Actual
Phase
Phase 3
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
liraglutide
glimepiride
liraglutide
placebo
placebo
placebo
Countries
United States
Mexico
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT00294723
Obsolete or Duplicate NCT IDs
NCT00853359
Organization Study
NN2211-1573
Secondary IDs
Not provided
Brief Title
To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c
Official Title
Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes
Acronym
LEAD-3
Organization
Novo Nordisk A/SINDUSTRY
Status Module
Record Verification Date
Jan 2017
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The trial was terminated at week 195 due to an insufficient number of subjects remaining to obtain reasonable statistical power
Expanded Access Info
No
Start Date
Feb 2006
Primary Completion Date
Nov 2008Actual
Completion Date
Nov 2008Actual
First Submitted Date
Feb 20, 2006
First Submission Date that Met QC Criteria
Feb 20, 2006
First Posted Date
Feb 22, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 23, 2010
Results First Submitted that Met QC Criteria
Feb 23, 2010
Results First Posted Date
Mar 12, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 9, 2009
Certification/Extension First Submitted that Passed QC Review
Nov 9, 2009
Certification/Extension First Posted Date
Nov 11, 2009Estimated
Last Update Submitted Date
Jan 24, 2017
Last Update Posted Date
Mar 7, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novo Nordisk A/SINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This trial is conducted in North America (the United States of America (USA) and Mexico).
The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes
Diabetes Mellitus, Type 2
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
746Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Lira 1.8
Experimental
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195).
Drug: liraglutide
Drug: placebo
Lira 1.2
Experimental
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195).
Drug: liraglutide
Drug: placebo
Glimepiride - 1
Active Comparator
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
Drug: glimepiride
Drug: placebo
Glimepiride - 2
Active Comparator
Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
Drug: glimepiride
Drug: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
liraglutide
Drug
1.8 mg for s.c. (under the skin) injection
Lira 1.8
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)
week 0, week 52
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)
week 0, week 104
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks
week 0, week 156
Secondary Outcomes
Measure
Description
Time Frame
Change in Body Weight at Week 52
Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)
week 0, week 52
Change in Body Weight at Week 104
Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes
TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months
Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive
OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive
Body Mass Index (BMI) less than or equal to 45 kg/m^2
Exclusion Criteria:
Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness
Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
Garber A, Henry R, Ratner R, Garcia-Hernandez PA, Rodriguez-Pattzi H, Olvera-Alvarez I, Hale PM, Zdravkovic M, Bode B; LEAD-3 (Mono) Study Group. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009 Feb 7;373(9662):473-81. doi: 10.1016/S0140-6736(08)61246-5. Epub 2008 Sep 24.
Subjects with type 2 diabetes treated with diet/exercise or OAD (Oral Anti-Diabetic Drug) monotherapy for at least 2 months were eligible. One subject randomised to the liraglutide 1.8 mg group was withdrawn from the study prior to dosing due to protocol non compliance, subject was not included in the intent-to-treat (ITT) or safety analysis sets.
Recruitment Details
A total of 138 centres in two countries: United States of America (USA) (126) and Mexico (12).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
FG001
Lira 1.2
Periods
Title
Milestones
Reasons Not Completed
Double-Blind Period 52 Weeks
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
glimepiride
Drug
8 mg capsule
Glimepiride - 1
Glimepiride - 2
liraglutide
Drug
1.2 mg for s.c. (under the skin) injection
Lira 1.2
placebo
Drug
Glimepiride placebo, 8mg capsule
Lira 1.2
Lira 1.8
placebo
Drug
Liraglutide placebo, 200 mcl
Glimepiride - 1
placebo
Drug
Liraglutide placebo, 300 mcl
Glimepiride - 2
week 0, week 104
Change in Body Weight at Week 156
Change in body weight from baseline (week 0) to 156 weeks
week 0, week 156
Change in Fasting Plasma Glucose at Week 52
Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)
week 0, week 52
Change in Fasting Plasma Glucose at Week 104
Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)
week 0, week 104
Change in Fasting Plasma Glucose at Week 156
Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks
week 0, week 156
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
week 0, week 52
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
week 0, week 104
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
week 0, week 156
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
week 0, week 52
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
week 0, week 104
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
week 0, week 156
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). 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 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
weeks 0-104
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). 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 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.
McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998.
Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x.
Jendle J, Nauck MA, Matthews DR, Frid A, Hermansen K, During M, Zdravkovic M, Strauss BJ, Garber AJ; LEAD-2 and LEAD-3 Study Groups. Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue. Diabetes Obes Metab. 2009 Dec;11(12):1163-72. doi: 10.1111/j.1463-1326.2009.01158.x.
Bode BW, Testa MA, Magwire M, Hale PM, Hammer M, Blonde L, Garber A; LEAD-3 Study Group. Patient-reported outcomes following treatment with the human GLP-1 analogue liraglutide or glimepiride in monotherapy: results from a randomized controlled trial in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Jul;12(7):604-12. doi: 10.1111/j.1463-1326.2010.01196.x.
Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.
Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.
Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.
Ingwersen SH, Khurana M, Madabushi R, Watson E, Jonker DM, Le Thi TD, Jacobsen LV, Tornoe CW. Dosing rationale for liraglutide in type 2 diabetes mellitus: a pharmacometric assessment. J Clin Pharmacol. 2012 Dec;52(12):1815-23. doi: 10.1177/0091270011430504. Epub 2011 Dec 15.
Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.
King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.
Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
Gilbert MP, Marre M, Holst JJ, Garber A, Baeres FM, Thomsen H, Pratley RE. COMPARISON OF THE LONG-TERM EFFECTS OF LIRAGLUTIDE AND GLIMEPIRIDE MONOTHERAPY ON BONE MINERAL DENSITY IN PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2016 Apr;22(4):406-11. doi: 10.4158/EP15758.OR. Epub 2015 Nov 17.
Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.
Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.
Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
FG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
FG000247 subjectsRandomised
FG001251 subjectsRandomised
FG002248 subjectsRandomised
Exposed to Study Drug
FG000246 subjectsSubject withdrew before exposure to drug, and thus not included in the safety and ITT analysis sets
FG001251 subjects
FG002248 subjects
COMPLETED
FG000173 subjects
FG001162 subjects
FG002152 subjects
NOT COMPLETED
FG00074 subjects
FG00189 subjects
FG00296 subjects
Type
Comment
Reasons
Adverse Event
FG00018 subjects
FG00125 subjects
FG00215 subjects
Lack of Efficacy
FG0009 subjects
FG00115 subjects
FG00225 subjects
Protocol Violation
FG00011 subjects
FG00111 subjects
FG0025 subjects
Not specified in study report
FG00036 subjects
FG00138 subjects
FG00251 subjects
Open-Label Extension 52 Weeks
Type
Comment
Milestone Data
STARTED
FG000154 subjects19 subjects did not continue into the extension period
FG001149 subjects13 subjects did not continue into the extension period
FG002137 subjects15 subjects did not continue into the extension period
COMPLETED
FG000114 subjects
FG001110 subjects
FG00297 subjects
NOT COMPLETED
FG00040 subjects
FG00139 subjects
FG00240 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0015 subjects
FG0022 subjects
Lack of Efficacy
FG000
Additional Open-Label Extension 91 Weeks
Type
Comment
Milestone Data
STARTED
FG00062 subjects52 subjects did not continue into the extension period
FG00153 subjects57 subjects did not continue into the extension period
FG00228 subjects69 subjects did not continue into the extension period
COMPLETED
FG00034 subjects
FG00132 subjects
FG0028 subjects
NOT COMPLETED
FG00028 subjects
FG00121 subjects
FG00220 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
Lack of Efficacy
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
BG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
BG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000247
BG001251
BG002248
BG003746
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00052.0± 10.8
BG00153.7± 11.0
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000126
BG001134
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00087
BG00181
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Mexico
Title
Measurements
BG00052
BG00153
BG002
Previous anti-diabetic treatment
Number
participants
Title
Denominators
Categories
Diet/Exercise
Title
Measurements
BG00087
BG00191
BG002
Body Mass Index (BMI)
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00032.8± 6.3
BG00133.2± 5.6
BG002
Duration of diabetes
Number of years since diagnosis
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG0005.3± 5.1
BG0015.2± 5.5
BG002
HbA1c (Glycosylated Haemoglobin A1c)
HbA1c at screening
Mean
Standard Deviation
percentage of total haemoglobin
Title
Denominators
Categories
Title
Measurements
BG0008.3± 1.1
BG0018.3± 1.0
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
percentage point of total HbA1c
week 0, week 52
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Units
Counts
Participants
OG000234
OG001236
OG002241
Title
Denominators
Categories
Title
Measurements
OG000-1.14± 0.08
OG001-0.84± 0.08
OG002-0.51± 0.08
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
ANCOVA
<0.0001
The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.62
95
-0.83
-0.42
Non-Inferiority or Equivalence
Secondary
Change in Body Weight at Week 52
Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
kg
week 0, week 52
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Secondary
Change in Body Weight at Week 104
Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
kg
week 0, week 104
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Primary
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
percentage point of total HbA1c
week 0, week 104
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Secondary
Change in Body Weight at Week 156
Change in body weight from baseline (week 0) to 156 weeks
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
kg
week 0, week 156
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Secondary
Change in Fasting Plasma Glucose at Week 52
Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
mg/dL
week 0, week 52
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Secondary
Change in Fasting Plasma Glucose at Week 104
Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
mg/dL
week 0, week 104
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Secondary
Change in Fasting Plasma Glucose at Week 156
Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
mg/dL
week 0, week 156
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Secondary
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
mg/dL
week 0, week 52
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Secondary
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
mg/dL
week 0, week 104
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Secondary
Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks. The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
mg/dL
week 0, week 156
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Primary
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
percentage point of total HbA1c
week 0, week 156
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Secondary
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
mg/dL
week 0, week 52
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Secondary
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension). The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
mg/dL
week 0, week 104
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Secondary
Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks. The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min. Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.
Posted
Least Squares Mean
Standard Error
mg/dL
week 0, week 156
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Secondary
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension). 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 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
Full safety analysis set is all subjects who had been exposed to at least one dose of the study products.
Posted
Number
episodes
weeks 0-104
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Secondary
Hypoglycaemic Episodes
Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195). 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 56 mg/dL. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
Safety analysis set is all subjects who entered the year 3 extension at week 104.
Posted
Number
episodes
weeks 104-195
ID
Title
Description
OG000
Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
OG001
Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
OG002
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Time Frame
The adverse events were collected in a time span of 195 weeks.
Description
The full safety analysis set is all subjects who had been exposed to at least one dose of the study products.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Lira 1.8 (Weeks 0-104)
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension period (weeks 52-104)
22
246
183
246
EG001
Lira 1.2 (Weeks 0-104)
Liraglutide 1.2 mg once daily + glimepiride placebo 8mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension period (weeks 52-104)
23
251
181
251
EG002
Glimepiride (Weeks 0-104)
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension period (weeks 52-104)
20
248
148
248
EG003
Lira 1.8 (Weeks 104-195)
Open-label liraglutide 1.8 mg once daily in the additional extension period (weeks 104-195)
5
62
40
62
EG004
Lira 1.2 (Weeks 104-195)
Open-label liraglutide 1.2 mg once daily in the additional extension period (weeks 104-195)
1
53
37
53
EG005
Glimepiride (Weeks 104-195)
Open-label glimepiride 8 mg once daily in the additional extension period (weeks 104-195)
2
28
13
28
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG0030 events0 affected62 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected28 at risk
Acute Myocardial Infarction
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0022 events2 affected248 at risk
EG003
Angina Unstable
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Ischaemic Cardiomyopathy
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0002 events2 affected246 at risk
EG0011 events1 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0022 events2 affected248 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Adrenocortical Insufficiency Acute
Endocrine disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0012 events2 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Thyroid Disorder
Endocrine disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Retinal Detachment
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Vision Blurred
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Appendicitis Perforated
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Crohn's Disease
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Diverticulum Oesophageal
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Oedematous Pancreatitis
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Chest Pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Abscess Limb
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Clostridial Infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Fungaemia
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Viral Infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Lower Limb Fracture
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Tendon Injury
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Traumatic Coma
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Lumbar Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Benign Neoplasm Of Thyroid Gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0002 events2 affected246 at risk
EG0011 events1 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Colon Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Colon Cancer Stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Nasopharyngeal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Thyroid Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Thyroid Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Grand Mal Convulsion
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Nerve Compression
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Radial Nerve Palsy
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0011 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0012 events1 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Urethral Stenosis
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Bronchitis Chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0021 events1 affected248 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Cervical myelopathy
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Pelvic haematoma
Reproductive system and breast disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG000117 events75 affected246 at risk
EG00197 events72 affected251 at risk
EG00231 events21 affected248 at risk
EG0030 events0 affected62 at risk
EG0040 events0 affected53 at risk
EG0050 events0 affected28 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG00066 events48 affected246 at risk
EG00175 events44 affected251 at risk
EG00237 events23 affected248 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG00036 events25 affected246 at risk
EG00138 events33 affected251 at risk
EG00212 events10 affected248 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG00035 events29 affected246 at risk
EG00124 events21 affected251 at risk
EG00212 events12 affected248 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG00014 events13 affected246 at risk
EG0014 events4 affected251 at risk
EG0025 events5 affected248 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG00042 events32 affected246 at risk
EG00148 events36 affected251 at risk
EG00230 events22 affected248 at risk
EG003
Influenza
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG00037 events27 affected246 at risk
EG00135 events23 affected251 at risk
EG00227 events21 affected248 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG00031 events18 affected246 at risk
EG00125 events21 affected251 at risk
EG00224 events18 affected248 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG00018 events14 affected246 at risk
EG00135 events26 affected251 at risk
EG00215 events13 affected248 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG00021 events16 affected246 at risk
EG00126 events23 affected251 at risk
EG00219 events18 affected248 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG00012 events9 affected246 at risk
EG00117 events15 affected251 at risk
EG00214 events11 affected248 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG00026 events18 affected246 at risk
EG00153 events28 affected251 at risk
EG00230 events23 affected248 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG00021 events19 affected246 at risk
EG00119 events13 affected251 at risk
EG00214 events13 affected248 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG00018 events17 affected246 at risk
EG00121 events18 affected251 at risk
EG00217 events17 affected248 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0006 events6 affected246 at risk
EG00114 events11 affected251 at risk
EG00215 events15 affected248 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG00015 events15 affected246 at risk
EG00110 events9 affected251 at risk
EG0029 events8 affected248 at risk
EG003
Fatigue
General disorders
MedDRA 12.1
Systematic Assessment
EG00015 events13 affected246 at risk
EG0019 events8 affected251 at risk
EG00210 events9 affected248 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG00016 events14 affected246 at risk
EG0016 events5 affected251 at risk
EG00213 events11 affected248 at risk
EG003
Depression
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG00014 events14 affected246 at risk
EG00111 events8 affected251 at risk
EG0025 events5 affected248 at risk
EG003
Hypertension
Vascular disorders
MedDRA 12.1
Systematic Assessment
EG00011 events11 affected246 at risk
EG00114 events14 affected251 at risk
EG00219 events17 affected248 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected246 at risk
EG0010 events0 affected251 at risk
EG0020 events0 affected248 at risk
EG003
Trial terminated due to an insufficient number of subjects remaining to obtain reasonable statistical power. Efficacy data was not analysed after week 156. Safety data was collected through week 195. No data was available from week 195 to 260
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Novo Nordisk reserves the right to not release data until specified milestones. This includes the right to not release interim results, because the release of such information can invalidate the results of the entire trial. At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
Point of Contact
Title
Organization
Phone
Extension
Email
Public Access to Clinical Trials
Novo Nordisk A/S
clinicaltrials@novonordisk.com
ID
Term
D003920
Diabetes Mellitus
D003924
Diabetes Mellitus, Type 2
Ancestor Terms
ID
Term
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069450
Liraglutide
C057619
glimepiride
Ancestor Terms
ID
Term
D052216
Glucagon-Like Peptide 1
D004763
Glucagon-Like Peptides
D052336
Proglucagon
D005768
Gastrointestinal Hormones
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
Browse Leaves
Not provided
Browse Branches
Not provided
12 subjects
FG00115 subjects
FG00221 subjects
Protocol Violation
FG0004 subjects
FG0013 subjects
FG0023 subjects
Not specified in study report
FG00019 subjects
FG00116 subjects
FG00214 subjects
24 subjects
FG00114 subjects
FG00216 subjects
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0021 subjects
Not specified in study report
FG0002 subjects
FG0015 subjects
FG0023 subjects
0
Between 18 and 65 years
BG000222
BG001208
BG002208
BG003638
>=65 years
BG00025
BG00143
BG00240
BG003108
53.4
± 10.9
BG00353.0± 10.9
115
BG003375
Male
BG000121
BG001117
BG002133
BG003371
93
BG003261
Not Hispanic or Latino
BG000160
BG001170
BG002155
BG003485
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
0
BG0030
Asian
BG00012
BG0015
BG0029
BG00326
Native Hawaiian or Other Pacific Islander
BG0002
BG0010
BG0020
BG0032
Black or African American
BG00030
BG00134
BG00230
BG00394
White
BG000186
BG001200
BG002192
BG003578
More than one race
BG0000
BG0010
BG0020
BG0030
Unknown or Not Reported
BG00017
BG00112
BG00217
BG00346
66
BG003171
United States
Title
Measurements
BG000195
BG001198
BG002182
BG003575
94
BG003272
Monotherapy
Title
Measurements
BG000160
BG001160
BG002154
BG003474
33.2
± 5.6
BG00333.1± 5.8
5.6
± 5.1
BG0035.4± 5.3
BG002
8.4
± 1.2
BG0038.3± 1.1
The two sided 95% confidence interval for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.
OG001
OG002
Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
ANCOVA
0.0014
The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.33
95
-0.53
-0.13
Non-Inferiority or Equivalence
The two sided 95% confidence interval for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.
OG000
OG001
Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
ANCOVA
0.0046
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.29
95
-0.50
-0.09
Non-Inferiority or Equivalence
A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.
Units
Counts
Participants
OG000240
OG001245
OG002248
Title
Denominators
Categories
Title
Measurements
OG000-2.45± 0.28
OG001-2.05± 0.28
OG0021.12± 0.27
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
ANCOVA
<.0001
2-sided significance level 5%
Estimated treatment difference, LS Mean
-3.58
95
-4.28
-2.87
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
ANCOVA
<.0001
2-sided significance level 5%
Estimated treatment difference, LS Mean
-3.17
95
-3.87
-2.47
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
ANCOVA
0.2584
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.41
95
-1.11
0.30
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Units
Counts
Participants
OG000240
OG001245
OG002248
Title
Denominators
Categories
Title
Measurements
OG000-2.70± 0.32
OG001-1.89± 0.31
OG0020.95± 0.30
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
ANCOVA
<.0001
2-sided significance level 5%
Estimated treatment difference, LS Mean
-3.65
95
-4.44
-2.86
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
ANCOVA
<.0001
2-sided significance level 5%
Estimated treatment difference, LS Mean
-2.84
95
-3.63
-2.06
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
ANCOVA
0.0462
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.80
95
-1.59
-0.01
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Units
Counts
Participants
OG000234
OG001236
OG002241
Title
Denominators
Categories
Title
Measurements
OG000-0.88± 0.09
OG001-0.59± 0.09
OG002-0.28± 0.09
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
ANCOVA
<.0001
The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.60
95
-0.83
-0.38
Non-Inferiority or Equivalence
The two sided 95% confidence interval for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.
OG001
OG002
Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
ANCOVA
0.0076
The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.31
95
-0.54
-0.08
Non-Inferiority or Equivalence
The two sided 95% CI for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.
OG000
OG001
Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
ANCOVA
0.0129
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.29
95
-0.52
-0.06
Non-Inferiority or Equivalence
A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.
Units
Counts
Participants
OG000240
OG001245
OG002248
Title
Denominators
Categories
Title
Measurements
OG000-2.43± 0.32
OG001-1.68± 0.32
OG0021.05± 0.31
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
ANCOVA
<0.0001
2-sided significance level was 5%.
Estimated treatment difference, LS Mean
-3.48
95
-4.28
-2.68
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.
ANCOVA
<0.0001
2-sided significance level 5%
Estimated treatment difference, LS Mean
-2.72
95
-3.52
-1.93
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariance.
ANCOVA
0.0642
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.75
95
-1.55
0.05
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Units
Counts
Participants
OG000230
OG001234
OG002242
Title
Denominators
Categories
Title
Measurements
OG000-25.57± 3.50
OG001-15.21± 3.50
OG002-5.29± 3.33
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
ANCOVA
<.0001
2-sided significance level 5%
Estimated treatment difference, LS Mean
-20.28
95
-29.09
-11.46
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
ANCOVA
0.0270
2-sided significance level 5%
Estimated treatment difference, LS Mean
-9.92
95
-18.70
-1.12
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
ANCOVA
0.0223
2-sided significance level 5%
Estimated treatment difference, LS Mean
-10.36
95
-19.24
-1.48
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Units
Counts
Participants
OG000230
OG001234
OG002242
Title
Denominators
Categories
Title
Measurements
OG000-15.82± 3.85
OG001-9.36± 3.85
OG0021.97± 3.66
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
ANCOVA
0.0003
2-sided significance level 5%
Estimated treatment difference, LS Mean
-17.79
95
-27.48
-8.09
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
ANCOVA
0.0217
2-sided significance level 5%
Estimated treatment difference, LS Mean
-11.33
95
-20.99
-1.66
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
ANCOVA
0.1942
2-sided significance level 5%
Estimated treatment difference, LS Mean
-6.46
95
-16.23
3.30
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg
Units
Counts
Participants
OG000230
OG001234
OG002242
Title
Denominators
Categories
Title
Measurements
OG000-12.06± 3.8
OG001-5.45± 3.8
OG0024.57± 3.62
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
ANCOVA
0.0007
2-sided significance level 5%
Estimated treatment difference, LS Mean
-16.63
95
-26.19
-7.06
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
ANCOVA
0.0395
2-sided significance level 5%
Estimated treatment difference, LS Mean
-10.02
95
-19.56
-0.49
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.
ANCOVA
0.1789
2-sided significance level 5%
Estimated treatment difference, LS Mean
-6.60
95
-16.24
3.03
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Units
Counts
Participants
OG000191
OG001187
OG002182
Title
Denominators
Categories
Title
Measurements
OG000-37.4± 3.37
OG001-30.8± 3.40
OG002-24.5± 3.32
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in mean postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
ANCOVA
0.0038
2-sided significance level 5%
Estimated treatment difference, LS Mean
-12.9
95
-21.6
-4.2
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
ANCOVA
0.1616
2-sided significance level 5%
Estimated treatment difference, LS Mean
-6.3
95
-15.0
2.5
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
ANCOVA
0.1319
2-sided significance level 5%
Estimated treatment difference, LS Mean
-6.6
95
-15.3
2.0
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Units
Counts
Participants
OG000191
OG001187
OG002183
Title
Denominators
Categories
Title
Measurements
OG000-37.15± 3.64
OG001-27.34± 3.68
OG002-24.85± 3.58
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
ANCOVA
0.0105
2-sided significance level 5%
Estimated treatment difference, LS Mean
-12.30
95
-21.71
-2.89
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
ANCOVA
0.6060
2-sided significance level 5%
Estimated treatment difference, LS Mean
-2.49
95
-11.95
6.98
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
ANCOVA
0.0392
2-sided significance level 5%
Estimated treatment difference, LS Mean
-9.81
95
-19.14
-0.49
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Units
Counts
Participants
OG000191
OG001187
OG002183
Title
Denominators
Categories
Title
Measurements
OG000-34.83± 3.65
OG001-25.68± 3.69
OG002-23.84± 3.59
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
ANCOVA
0.0227
2-sided significance level 5%
Estimated treatment difference, LS Mean
-10.98
95
-20.42
-1.54
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
ANCOVA
0.7047
2-sided significance level 5%
Estimated treatment difference, LS Mean
-1.83
95
-11.33
7.66
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.
ANCOVA
0.0553
2-sided significance level 5%
Estimated treatment difference, LS Mean
-9.15
95
-18.51
0.21
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Units
Counts
Participants
OG000234
OG001236
OG002241
Title
Denominators
Categories
Title
Measurements
OG000-0.71± 0.09
OG001-0.44± 0.09
OG002-0.16± 0.08
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
ANCOVA
<0.0001
The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.
Estimated treatment difference, LS Mean
-0.55
95
-0.77
-0.34
Non-Inferiority or Equivalence
The two-sided 95% confidence interval (CI) for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%.
OG001
OG002
Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
ANCOVA
0.0122
The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.
Estimated treatment difference, LS Mean
-0.28
95
-0.49
-0.06
Non-Inferiority or Equivalence
The two-sided 95% confidence interval (CI) for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.
OG000
OG001
Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.
ANCOVA
0.0123
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.28
95
-0.49
-0.06
Non-Inferiority or Equivalence
A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Units
Counts
Participants
OG000191
OG001187
OG002182
Title
Denominators
Categories
Title
Measurements
OG000-9.6± 2.07
OG001-8.4± 2.10
OG002-5.6± 2.04
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
ANCOVA
0.1396
2-sided significance level 5%
Estimated treatment difference, LS Mean
-4.0
95
-9.4
1.3
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
ANCOVA
0.2968
2-sided significance level 5%
Estimated treatment difference, LS Mean
-2.9
95
-8.3
2.5
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in postprandial (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
ANCOVA
0.6639
2-sided significance level 5%
Estimated treatment difference, LS Mean
-1.2
95
-6.5
4.1
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Units
Counts
Participants
OG000191
OG001187
OG002183
Title
Denominators
Categories
Title
Measurements
OG000-11.76± 2.11
OG001-8.28± 2.14
OG002-7.95± 2.08
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
ANCOVA
0.1720
2-sided significance level 5%
Estimated treatment difference, LS Mean
-3.81
95
-9.28
1.66
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
ANCOVA
0.9060
2-sided significance level 5%
Estimated treatment difference, LS Mean
-0.33
95
-5.82
5.16
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
ANCOVA
0.2089
2-sided significance level 5%
Estimated treatment difference, LS Mean
-3.48
95
-8.91
1.95
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.
Glimepiride
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
Units
Counts
Participants
OG000191
OG001187
OG002183
Title
Denominators
Categories
Title
Measurements
OG000-11.01± 2.11
OG001-7.53± 2.14
OG002-7.97± 2.07
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
ANCOVA
0.2749
2-sided significance level 5%
Estimated treatment difference, LS Mean
-3.04
95
-8.51
2.42
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG001
OG002
Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
ANCOVA
0.8765
2-sided significance level 5%
Estimated treatment difference, LS Mean
0.43
95
-5.05
5.92
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.
OG000
OG001
Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.
ANCOVA
0.2088
2-sided significance level 5%
Estimated treatment difference, LS Mean
-3.48
95
-8.90
1.95
Non-Inferiority or Equivalence
A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.