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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-060324 | Registry Identifier | japic |
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This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.6 mg + SU | Experimental | Liraglutide 0.6 mg + sulphonylurea |
|
| 0.9 mg + SU | Experimental | Liraglutide 0.9 mg + sulphonylurea |
|
| SU Mono - 1 | Placebo Comparator | Liraglutide placebo 0.6 mg + sulphonylurea |
|
| SU Mono - 2 | Placebo Comparator | Liraglutide placebo 0.9 mg + sulphonylurea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sulfonylurea | Drug | SU agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment | after 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment | after 52 weeks of treatment | |
| Fasting Plasma Glucose After 24 Weeks of Treatment | after 24 weeks of treatment | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tokyo | 1000005 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24843595 | Result | Seino Y, Rasmussen MF, Clauson P, Kaku K. The once-daily human glucagon-like peptide-1 analog, liraglutide, improves beta-cell function in Japanese patients with type 2 diabetes. J Diabetes Investig. 2012 Aug 20;3(4):388-95. doi: 10.1111/j.2040-1124.2012.00193.x. | |
| 20380655 | Result | Kaku K, Rasmussen MF, Clauson P, Seino Y. Improved glycaemic control with minimal hypoglycaemia and no weight change with the once-daily human glucagon-like peptide-1 analogue liraglutide as add-on to sulphonylurea in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2010 Apr;12(4):341-7. doi: 10.1111/j.1463-1326.2009.01194.x. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Subjects included were patients with type 2 diabetes treated with diet therapy and one sulphonylurea (SU) agent (glibenclamide, gliclazide or glimepiride). Subjects continued their current SU therapy with, as a rule, no change in the dose and dosage in the study. A total of 267 subjects were randomised, 3 subjects were not exposed to study drug.
49 sites in Japan
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0.6 mg + SU | Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment |
| FG001 | 0.9 mg + SU | Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment |
| FG002 | SU Mono | Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.6 mg + SU | Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment |
| BG001 | 0.9 mg + SU | Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | percentage of total haemoglobin | after 24 weeks of treatment |
|
Adverse events were collected in a time span over 52 weeks.
The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.6 mg + SU | Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
Not provided
Not provided
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| liraglutide | Drug | Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily. |
|
| liraglutide | Drug | Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily. |
|
| Fasting Plasma Glucose After 52 Weeks of Treatment |
| after 52 weeks of treatment |
| Postprandial Glucose AUC After 24 Weeks of Treatment | Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment | after 24 weeks of treatment |
| Postprandial Glucose AUC After 52 Weeks of Treatment | Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment | after 52 weeks of treatment |
| Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment | Plasma glucose (PG) profile measured after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. | after 24 weeks of treatment |
| Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment | 7-point plasma glucose (PG) profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. | after 52 weeks of treatment |
| Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment | Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. | after 24 weeks of treatment |
| Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment | Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. | after 52 weeks of treatment |
| Body Weight After 24 Weeks of Treatment | after 24 weeks of treatment |
| Body Weight After 52 Weeks of Treatment | after 52 weeks of treatment |
| Hypoglycaemic Episodes | Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | over 52 weeks of treatment |
| 23010561 | Result | Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23. |
| 25504028 | Result | 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. |
| 21450987 | Derived | 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. |
| 21209033 | Derived | 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. |
| Lack of Efficacy |
|
| Hypoglycaemia |
|
| Subject decision |
|
| Withdrawal of consent |
|
| Difficultulty in use of device |
|
| Unable to visit site on schedule |
|
| BG002 | SU Mono | Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Body weight | Mean | Standard Deviation | kg |
|
| Duration of diabetes | Number of years since diagnosis of diabetes | Mean | Standard Deviation | years |
|
| HbA1c | Glycosylated Haemoglobin | Mean | Standard Deviation | percentage of total haemoglobin |
|
| OG002 | SU Mono | Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment |
|
|
|
| Secondary | Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | percentage of total haemoglobin | after 52 weeks of treatment |
|
|
|
|
| Secondary | Fasting Plasma Glucose After 24 Weeks of Treatment | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | mg/dL | after 24 weeks of treatment |
|
|
|
|
| Secondary | Fasting Plasma Glucose After 52 Weeks of Treatment | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | mg/dL | after 52 weeks of treatment |
|
|
|
|
| Secondary | Postprandial Glucose AUC After 24 Weeks of Treatment | Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | mg/dL *h | after 24 weeks of treatment |
|
|
|
|
| Secondary | Postprandial Glucose AUC After 52 Weeks of Treatment | Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | mg/dL *h | after 52 weeks of treatment |
|
|
|
|
| Secondary | Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment | Plasma glucose (PG) profile measured after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | mg/dL | after 24 weeks of treatment |
|
|
|
|
| Secondary | Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment | 7-point plasma glucose (PG) profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | mg/dL | after 52 weeks of treatment |
|
|
|
|
| Secondary | Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment | Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | mg/dL | after 24 weeks of treatment |
|
|
|
|
| Secondary | Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment | Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime. | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | mg/dL | after 52 weeks of treatment |
|
|
|
|
| Secondary | Body Weight After 24 Weeks of Treatment | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | kg | after 24 weeks of treatment |
|
|
|
|
| Secondary | Body Weight After 52 Weeks of Treatment | Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline. | Posted | Least Squares Mean | Standard Error | kg | after 52 weeks of treatment |
|
|
|
|
| Secondary | Hypoglycaemic Episodes | Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug. | Posted | Number | number of events per year of exposure | over 52 weeks of treatment |
|
|
|
|
| 4 |
| 88 |
| 68 |
| 88 |
| EG001 | 0.9 mg + SU | Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment | 3 | 88 | 68 | 88 |
| EG002 | SU Mono | Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment | 5 | 88 | 59 | 88 |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Benign neoplasm of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Epiglottic cyst | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
| Sulfur Compounds |
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed. |
| ANOVA |
| Least Squares Mean |
| -0.96 |
| 95 |
| -1.25 |
| -0.67 |
| Superiority or Other |
| Superiority or Other |
| ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. | ANOVA | <0.0001 | To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%. | Least Squares Mean | -26.4 | 95 | -34.5 | -18.2 | Superiority or Other |
95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed. |
| ANOVA |
| Least Squares Mean |
| -24.4 |
| 95 |
| -33.8 |
| -14.9 |
| Superiority or Other |
| Superiority or Other |
| ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. | ANOVA | <0.0001 | To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%. | Least Squares Mean | -111.15 | 95 | -147.61 | -74.68 | Superiority or Other |
95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed. |
| ANOVA |
| Least Squares Mean |
| -68.68 |
| 95 |
| -108.91 |
| -28.45 |
| Superiority or Other |
| Superiority or Other |
| ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. | ANOVA | <0.0001 | To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%. | Least Squares Mean | -34.30 | 95 | -45.06 | -23.54 | Superiority or Other |
95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed. |
| ANOVA |
| Least Squares Mean |
| -46.34 |
| 95 |
| -58.49 |
| -34.18 |
| Superiority or Other |
| Superiority or Other |
| ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. | ANOVA | 0.2359 | To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%. | Least Squares Mean | 6.67 | 95 | -4.39 | 17.73 | Superiority or Other |
95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed. |
| ANOVA |
| Least Squares Mean |
| -7.11 |
| 95 |
| -18.42 |
| 4.21 |
| Superiority or Other |
| Superiority or Other |
| ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. | ANOVA | <0.0001 | To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%. | Least Squares Mean | 1.18 | 95 | 0.63 | 1.73 | Superiority or Other |
95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed |
| ANOVA |
| Least Squares Mean |
| 1.13 |
| 95 |
| 0.51 |
| 1.75 |
| Superiority or Other |
|
| Minor |
|
| Symptoms only |
|
The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.
| Negative binomial regression model |
| Rate ratio |
| 1.18 |
| 95 |
| 0.56 |
| 2.47 |
| Superiority or Other |
| The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable. | Negative binomial regression model | Rate ratio | 1.80 | 95 | 0.92 | 3.54 | Superiority or Other |
| The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable. | Negative binomial regression model | Rate ratio | 1.62 | 95 | 0.85 | 3.07 | Superiority or Other |
| The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable. | Negative binomial regression model | Rate ratio | 1.48 | 95 | 0.69 | 3.17 | Superiority or Other |
| The relative risk for 'Symptoms only episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable. | Negative binomial regression model | Rate ratio | 1.45 | 95 | 0.72 | 2.91 | Superiority or Other |