Clinical Trial Details
| Trial ID: | L6082 |
| Source ID: | NCT01880736 |
| Associated Drug: | Insulin Degludec |
| Title: | A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01880736/results |
| Conditions: | Diabetes|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: insulin degludec|DRUG: insulin degludec|DRUG: insulin degludec |
| Outcome Measures: | Primary: Change From Baseline in HbA1c (%) Glycosylated Haemoglobin), Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise), Week 0, week 26 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG), Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)., Week 0, week 26|Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial, The number of subjects who achieved the pre-defined HbA1c target (\<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)., After 26 weeks of treatment|Incidence of Treatment Emergent Adverse Events (TEAEs), The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise)., Weeks 0-26|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL)), The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L \[less than 56 mg/dL\]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise)., Weeks 0-26|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition, Number of treatment emergent hypoglycaemic episodes according to the ADA definition (classified as severe hypoglycaemia, documented hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia, relative hypoglycaemia) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)., Weeks 0-26|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period, The number of treatment mergent confirmed hypoglycaemic episodes in the maintenance period from Week 16 to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs. stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L., From Week 16 to end of trial (week 27)|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes, The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m., Weeks 0-26|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period, The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes in the maintenance period from 16 weeks to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m., From week 16 to end of trial (week 27) |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 458 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2013-06 |
| Completion Date: | 2014-04 |
| Results First Posted: | 2016-03-17 |
| Last Update Posted: | 2017-02-10 |
| 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, Fukui-shi, Fukui, 918-8503, Japan|Novo Nordisk Investigational Site, Fukuoka, 812 0025, Japan|Novo Nordisk Investigational Site, Gifu-shi, Gifu, 501-1194, Japan|Novo Nordisk Investigational Site, Izumisano-shi, 598 0048, Japan|Novo Nordisk Investigational Site, Kagoshima-shi, Kagoshima, 890-8520, Japan|Novo Nordisk Investigational Site, Kamakura-shi, 247 0056, Japan|Novo Nordisk Investigational Site, Kashiwara-shi, Osaka, 582 0005, Japan|Novo Nordisk Investigational Site, Katsushika-ku, Tokyo, 125 0054, Japan|Novo Nordisk Investigational Site, Kawasaki-shi, Kanagawa, 216-8511, Japan|Novo Nordisk Investigational Site, Kitakyushu-shi, Fukuoka, 800 0252, Japan|Novo Nordisk Investigational Site, Kitakyushu-shi, Fukuoka, 807-8555, Japan|Novo Nordisk Investigational Site, Kitakyusyu-shi, Fukuoka, 800-0222, 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, Mito-shi, Ibaraki, 310-0845, 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, 951-8520, Japan|Novo Nordisk Investigational Site, Nishinomiya-shi, Hyogo, 663-8501, Japan|Novo Nordisk Investigational Site, Oita-shi, 870 0039, 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, Oyama-shi, Tochigi, 323 0022, Japan|Novo Nordisk Investigational Site, Sakaide-shi, Kagawa, 762-0031, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 060 0062, 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, Sendai-shi, 980 0021, Japan|Novo Nordisk Investigational Site, Shimotsuke-shi, Tochigi, 329 0433, Japan|Novo Nordisk Investigational Site, Suita-shi, Osaka, 565-0853, Japan|Novo Nordisk Investigational Site, Takatsuki-shi, Osaka, 569 1096, Japan|Novo Nordisk Investigational Site, Tokyo, 103-0028, Japan|Novo Nordisk Investigational Site, Tokyo, 113-8655, Japan|Novo Nordisk Investigational Site, Tokyo, 123-0845, Japan|Novo Nordisk Investigational Site, Tokyo, 143-8541, Japan|Novo Nordisk Investigational Site, Tokyo, 144-0051, Japan|Novo Nordisk Investigational Site, Tokyo, 162-8655, Japan|Novo Nordisk Investigational Site, Yokkaichi-shi, Mie, 510-0829, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01880736 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|