Clinical Trial Details
| Trial ID: | L2401 |
| Source ID: | NCT02207374 |
| Associated Drug: | Semaglutide |
| Title: | A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes |
| Acronym: | SUSTAIN™ |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02207374/results |
| Conditions: | Diabetes|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: semaglutide|DRUG: DPP-4 inhibitor |
| Outcome Measures: | Primary: Number of Treatment Emergent Adverse Events (TEAEs), An adverse event (AEs) was defined as any unfavorable 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 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days)., Weeks 0-56 | 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 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days)., Weeks 0-56|Change in Glycosylated Haemoglobin A1c (HbA1c), The observed mean change in HbA1c values from baseline after 56 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, week 56 |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 601 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2014-08-04 |
| Completion Date: | 2016-02-27 |
| Results First Posted: | 2019-01-07 |
| Last Update Posted: | 2019-01-07 |
| Locations: | Novo Nordisk Investigational Site, Akita-shi, Akita, 010 8543, Japan|Novo Nordisk Investigational Site, Annaka-shi, Gunma, 379 0116, Japan|Novo Nordisk Investigational Site, Asahikawa-shi, Hokkaido, 070 0002, Japan|Novo Nordisk Investigational Site, Asahikawa-shi, Hokkaido, 078 8510, Japan|Novo Nordisk Investigational Site, Bunkyo-ku, Tokyo, 113 8431, 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 0002, Japan|Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103 0027, Japan|Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 104-0061, Japan|Novo Nordisk Investigational Site, Fukuoka, 812 0025, Japan|Novo Nordisk Investigational Site, Higashiosaka-shi, Osaka, 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, 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, Kyoto-shi, Kyoto, 615 8125, Japan|Novo Nordisk Investigational Site, Mito-shi, Ibaraki, Japan|Novo Nordisk Investigational Site, Miyazaki-shi, 880 0034, 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, Nishinomiya-shi, Hyogo, 663-8501, Japan|Novo Nordisk Investigational Site, Okawa-shi, Fukuoka, 831 0016, Japan|Novo Nordisk Investigational Site, Okayama-shi, Okayama, 700 8505, Japan|Novo Nordisk Investigational Site, Osaka-shi, Osaka, 532 0003, Japan|Novo Nordisk Investigational Site, Ota-ku, Tokyo, 144 0035, Japan|Novo Nordisk Investigational Site, Ota-ku, Tokyo, Japan|Novo Nordisk Investigational Site, Oyama-shi, Tochigi, 323 0022, Japan|Novo Nordisk Investigational Site, Saga-shi,Saga, 849 0937, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 060 0062, 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, Shinjuku-ku, Tokyo, 160-0008, Japan|Novo Nordisk Investigational Site, Shizuoka-shi, 424 0853, 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, 123-0845, Japan|Novo Nordisk Investigational Site, Ube-shi, Yamaguchi, Japan|Novo Nordisk Investigational Site, Yokohama-shi, 235 0045, Japan |
| URL: | https://clinicaltrials.gov/show/NCT02207374 |
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