Clinical Trial Details
| Trial ID: | L5901 |
| Source ID: | NCT02254291 |
| Associated Drug: | Semaglutide |
| Title: | A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes |
| Acronym: | SUSTAIN™ |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02254291/results |
| Conditions: | Diabetes|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: semaglutide|DRUG: semaglutide|DRUG: sitagliptin |
| Outcome Measures: | Primary: Number of Treatment Emergent Adverse Events (TEAEs), An adverse events (AEs) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days)., Weeks 0-30 | Secondary: Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes, Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days)., Weeks 0-30|Change in Glycosylated Haemoglobin A1c (HbA1c), Mean changes in HbA1c values from baseline after 30 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the "on-treatment without rescue medication" observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication., Week 0 and week 30 |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 308 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2014-10-02 |
| Completion Date: | 2015-11-11 |
| Results First Posted: | 2018-09-13 |
| Last Update Posted: | 2018-09-13 |
| Locations: | Novo Nordisk Investigational Site, Asahikawa-shi, Hokkaido, 070 0002, Japan|Novo Nordisk Investigational Site, Chitose, Hokkaido, 066-0032, Japan|Novo Nordisk Investigational Site, Chuo-ku Tokyo, 103-0027, Japan|Novo Nordisk Investigational Site, Chuo-ku Tokyo, 104-0031, Japan|Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103 0027, Japan|Novo Nordisk Investigational Site, Ebina-shi, 243 0432, Japan|Novo Nordisk Investigational Site, Izumisano-shi, 598 0048, 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, Kumamoto-shi,Kumamoto, 862 0976, Japan|Novo Nordisk Investigational Site, Naka-shi, Ibaraki, 311 0113, Japan|Novo Nordisk Investigational Site, Nishinomiya-shi, Hygo, 662 0971, Japan|Novo Nordisk Investigational Site, Oita-shi, 870 0039, Japan|Novo Nordisk Investigational Site, Osaka-shi, Osaka, 553 0003, Japan|Novo Nordisk Investigational Site, Ota-ku, Tokyo, 144 0035, Japan|Novo Nordisk Investigational Site, Ota-ku, Tokyo, 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, Shimotsuke-shi, Tochigi, 329 0433, Japan|Novo Nordisk Investigational Site, Shinjuku-ku, Tokyo, 160-0008, 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, 181-0013, Japan|Novo Nordisk Investigational Site, Yokohama, Kanagawa, 236-0004, Japan|Novo Nordisk Investigational Site, Yokohama-shi, 235 0045, Japan |
| URL: | https://clinicaltrials.gov/show/NCT02254291 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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