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This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. 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 |
|---|---|---|---|
| Liraglutide | Experimental | Liraglutide 0.9 mg + glibenclamide placebo |
|
| Glibenclamide | Active Comparator | Glibenclamide 1.25-2.5 mg + liraglutide placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | 0.9 mg/day. Injected s.c. (under the skin) once daily. |
| |
| 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 | |
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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 |
|---|---|---|---|
| 20199137 | Result | Seino Y, Rasmussen MF, Nishida T, Kaku K. Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin. 2010 May;26(5):1013-22. doi: 10.1185/03007991003672551. | |
| 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Subjects included in the study were patients with type 2 diabetes treated with diet therapy only or diet therapy and one OAD (Oral Anti-Diabetic Drug). Subjects on OAD therapy discontinued their current treatment during the run-in period (Weeks 4-6 before dosing). A total of 411 subjects were randomised, 11 subjects were not exposed to study drug.
75 sites in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide | Liraglutide 0.9 mg + glibenclamide placebo |
| FG001 | Glibenclamide | Glibenclamide 1.25-2.5 mg + liraglutide placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide | Liraglutide 0.9 mg + glibenclamide placebo |
| BG001 | Glibenclamide | Glibenclamide 1.25-2.5 mg + liraglutide placebo |
| 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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liraglutide | Liraglutide 0.9 mg + glibenclamide placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac 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 |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| glibenclamide |
| Drug |
1.25-2.5 mg tablet. Given orally once or twice daily. |
|
| placebo | Drug | liraglutide placebo. Injected s.c. (under the skin) once daily. |
|
| placebo | Drug | glibenclamide placebo. Given orally once or twice 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 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 | Mean plasma glucose(PG) in 7-point plasma glucose 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. |
| 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 |
|
| Missed measurement |
|
| Move |
|
| BG002 | 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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 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 | Mean plasma glucose(PG) in 7-point plasma glucose 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 |
|
|
|
|
| 20 |
| 268 |
| 172 |
| 268 |
| EG001 | Glibenclamide | Glibenclamide 1.25-2.5 mg + liraglutide placebo | 14 | 132 | 91 | 132 |
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Ventriculoperitoneal shunt malfunction | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood creatine phosphokinase MB | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Spinal ligament ossification | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Colon polypectomy | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nausea | 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 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | 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.
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| 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 |
| 0.18 |
| 95 |
| 0.09 |
| 0.36 |
| 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 | 0.20 | 95 | 0.11 | 0.34 | Superiority or Other |