Clinical Trial Details
| Trial ID: | L5434 |
| Source ID: | NCT01647542 |
| Associated Drug: | Tak-875 |
| Title: | Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes |
| Acronym: | GRAND-307 |
| Status: | TERMINATED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01647542/results |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: TAK-875|DRUG: TAK-875 Placebo |
| Outcome Measures: | Primary: Change From Baseline in HbA1c at Week 24, The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline., Baseline and Week 24 | Secondary: Percentage of Participants With HbA1c <7% at Week 24, Week 24|Change in Fasting Plasma Glucose From Baseline to Week 24, The change between the fasting plasma glucose value collected at Week 24 relative to baseline., Baseline and Week 24|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24, The change between the value of glucose after a meal, measured following OGTT collected at Week 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, and C-peptide through blood samples drawn at 0, 30, 60, 90, and 120 minutes following consumption of a 75 gram (g) glucose beverage., Baseline and Week 24 |
| Sponsor/Collaborators: | Sponsor: Takeda |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 393 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2012-10 |
| Completion Date: | 2014-03 |
| Results First Posted: | 2015-08-19 |
| Last Update Posted: | 2015-11-11 |
| Locations: | Brookvale, New South Wales, Australia|Maroubra, New South Wales, Australia|Mosman, New South Wales, Australia|Woy Woy, New South Wales, Australia|Elizabeth Vale, South Australia, Australia|Hefei, Anhui, China|Beijing,P.R., Beijing, China|Beijing, Beijing, China|Chongqing, Chongqing, China|Fuzhou, Fujian, China|Xiamen, Fujian, China|Guangzhou, Guangdong, China|Guiyang, Guizhou, China|Shijiazhuang, Hebei, China|Harbin, Heilongjiang, China|Wuhan, Hubei, China|Changsha, Hunan, China|Chenzhou, Hunan, China|Nanjing, Jiangsu, China|Suzhou City, Jiangsu, China|Suzhou, Jiangsu, China|Changchun City, Jilin Province, Jilin, China|Changchun, Jilin, China|Xi'an, Shaanxi, China|Shanghai, Shanghai, China|Xi'an, Shanxi, China|Chengdu, Sichuan, China|Tianjin, Tianjin, China|Beijing, China|Chongqing, China|Guangzhou, China|Guiyang, China|Heilongjiang, China|Nanjing, China|Shanghai, China|Tianjin, China|Goyang-si, Gyeonggi-do, Korea, Republic of|Seongnam-si, Gyeonggi-do, Korea, Republic of|Suwon, Gyeonggi-do, Korea, Republic of|Gyeonggi, Korea, Republic of|Incheon, Korea, Republic of|Seoul, Korea, Republic of|Auckland, New Zealand|Hamilton, New Zealand|Rotorua, New Zealand|Tauranga, New Zealand|Wellington, New Zealand|Kaohsiung, Taiwan|New Taipei City, Taiwan|Taichung, Taiwan|Tainan, Taiwan|Taipei City, Taiwan|Taipei, Taiwan |
| URL: | https://clinicaltrials.gov/show/NCT01647542 |
