Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1121-3457 | Other Identifier | WHO | |
| JapicCTI-121744 | Registry Identifier | JAPIC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide + an OAD therapy | Experimental |
| |
| Two OADs combination therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | 0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (AEs) | Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly. | Week 0 to Week 52 + 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Confirmed Hypoglycaemic Episodes | Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Chuo-ku, Tokyo | 103 0002 | Japan | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26816604 | Result | Kaku K, Kiyosue A, Ono Y, Shiraiwa T, Kaneko S, Nishijima K, Bosch-Traberg H, Seino Y. Liraglutide is effective and well tolerated in combination with an oral antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 52-week, open-label, parallel-group trial. J Diabetes Investig. 2016 Jan;7(1):76-84. doi: 10.1111/jdi.12367. Epub 2015 Jul 14. | |
| 28984041 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
The trial was conducted at 36 sites in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide 0.9 mg/Day | Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| oral anti-diabetic drug | Drug | An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose. |
|
| Week 0 to Week 52 |
| Change in HbA1c From Baseline to Week 52 | Estimated mean change in HbA1c from baseline after 52 Weeks of treatment | Week 0, week 52 |
| Change in FPG From Baseline to Week 52 | Estimated mean change from baseline in FPG after 52 Weeks of treatment | Week 0, week 52 |
| Chuo-ku, Tokyo |
| 103 0027 |
| Japan |
| Novo Nordisk Investigational Site | Ehime, Japan | 790 0067 | Japan |
| Novo Nordisk Investigational Site | Fukuoka | 812 0025 | Japan |
| Novo Nordisk Investigational Site | Fukuoka | 818 8502 | Japan |
| Novo Nordisk Investigational Site | Fukuoka | 820 8505 | Japan |
| Novo Nordisk Investigational Site | Fukuoka, Japan | 810 8798 | Japan |
| Novo Nordisk Investigational Site | Fukuoka-shi, Fukuoka | 815 8555 | Japan |
| Novo Nordisk Investigational Site | Kamagaya-shi, Chiba | 273 0121 | Japan |
| Novo Nordisk Investigational Site | Kashiwara-shi, Osaka | 582 0005 | Japan |
| Novo Nordisk Investigational Site | Kawagoe-shi, Saitama | 350 0851 | Japan |
| Novo Nordisk Investigational Site | Kitakyushu-shi, Fukuoka | 800 0252 | Japan |
| Novo Nordisk Investigational Site | Koriyama-shi, Fukushima | 963 8851 | Japan |
| Novo Nordisk Investigational Site | Kumamoto-shi,Kumamoto | 862 0976 | Japan |
| Novo Nordisk Investigational Site | Kurume-shi, Fukuoka | 839 0863 | Japan |
| Novo Nordisk Investigational Site | Miyazaki | 880 0034 | Japan |
| Novo Nordisk Investigational Site | Naka-shi, Ibaraki | 311 0113 | Japan |
| Novo Nordisk Investigational Site | Niigata-shi, Niigata | 950 1104 | Japan |
| Novo Nordisk Investigational Site | Okawa-shi, Fukuoka | 831 0016 | Japan |
| Novo Nordisk Investigational Site | Osaka-shi, Osaka | 532 0003 | Japan |
| Novo Nordisk Investigational Site | Osaka-shi, Osaka | 545 8586 | Japan |
| Novo Nordisk Investigational Site | Ota-ku, Tokyo | 144 0035 | Japan |
| Novo Nordisk Investigational Site | Oyama-shi, Tochigi | 323 0022 | Japan |
| Novo Nordisk Investigational Site | Ōita | 870 8511 | Japan |
| Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | 060-0001 | Japan |
| Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | 062 0007 | Japan |
| Novo Nordisk Investigational Site | Shimotsuke-shi, Tochigi | 329 0433 | Japan |
| Novo Nordisk Investigational Site | Shizuoka | 424 0853 | Japan |
| Novo Nordisk Investigational Site | Tagajō-shi | 985 0852 | Japan |
| Novo Nordisk Investigational Site | Takatsuki-shi, Osaka | 569 1096 | Japan |
| Novo Nordisk Investigational Site | Tochigi | 329 0498 | Japan |
| Novo Nordisk Investigational Site | Tokyo | 104 0044 | Japan |
| Novo Nordisk Investigational Site | Tokyo | 113 0031 | Japan |
| Novo Nordisk Investigational Site | Tokyo | 125 0054 | Japan |
| Novo Nordisk Investigational Site | Yamaguchi | 755 0067 | Japan |
| Novo Nordisk Investigational Site | Yokohama | 235 0045 | Japan |
| Kiyosue A, Seino Y, Nishijima K, Bosch-Traberg H, Kaku K. Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial. J Diabetes Investig. 2018 Jul;9(4):831-839. doi: 10.1111/jdi.12759. Epub 2017 Nov 24. |
| FG001 | Additional OAD | Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling. |
| Exposed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide 0.9 mg/Day | Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg. |
| BG001 | Additional OAD | Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Glycosylated haemoglobin (HbA1c) | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
| |||||||||||||||
| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mmol/L |
|
| 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 | Incidence of Treatment Emergent Adverse Events (AEs) | Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly. | Safety analysis set included all subjects who received at least one dose of the trial product. | Posted | Number | Events/100 years of patient exposure | Week 0 to Week 52 + 7 days |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Confirmed Hypoglycaemic Episodes | Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL). | Safety analysis set includes all subjects who received at least one dose of the trial product. | Posted | Number | episodes | Week 0 to Week 52 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in HbA1c From Baseline to Week 52 | Estimated mean change in HbA1c from baseline after 52 Weeks of treatment | Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52. | Posted | Mean | Standard Error | percentage of glycosylated haemoglobin | Week 0, week 52 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in FPG From Baseline to Week 52 | Estimated mean change from baseline in FPG after 52 Weeks of treatment | Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52. | Posted | Mean | Standard Error | mmol/L | Week 0, week 52 |
|
|
Adverse events were captured from the time of consent until 52 weeks of treatment and if needed were followed up after the final visit.
Safety analysis set included all subjects who received at least one dose of the trial product.
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 | Liraglutide 0.9 mg/Day | Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg. | 11 | 240 | 161 | 240 | ||
| EG001 | Additional OAD | Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling. | 10 | 120 | 77 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Meningitis herpes | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Gastric cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Lung carcinoma unspecified stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Prostate cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Limb operation | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
Novo Nordisk maintains the right to be informed of any Investigator plans for publication and review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Novo Nordisk reserves the right to prior review of such publications and ask for delay of publication of individual site results until after the primary manuscript is accepted for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| 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 |
|---|---|
| D000069450 | Liraglutide |
| 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 |
Not provided
Not provided
| Male |
|
| Moderate AEs |
|
| Severe AEs |
|
| Serious AEs |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|