Clinical Trial Details
| Trial ID: | L4880 |
| Source ID: | NCT01512108 |
| Associated Drug: | Liraglutide |
| Title: | Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01512108/results |
| Conditions: | Diabetes|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: liraglutide|DRUG: oral anti-diabetic drug |
| Outcome Measures: | 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., 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)., 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 |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 363 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2012-01-10 |
| Completion Date: | 2013-04-26 |
| Results First Posted: | 2014-05-28 |
| Last Update Posted: | 2017-12-18 |
| Locations: | Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103 0002, Japan|Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103 0027, Japan|Novo Nordisk Investigational Site, Ehime, Japan, 790 0067, Japan|Novo Nordisk Investigational Site, Fukuoka, Japan, 810 8798, Japan|Novo Nordisk Investigational Site, Fukuoka-shi, Fukuoka, 815 8555, 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, 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-shi, 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, Oita, 870 8511, 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, 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-shi, 424 0853, Japan|Novo Nordisk Investigational Site, Tagajo-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-shi, 235 0045, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01512108 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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