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Clinical Trial Details

Trial ID: L6858
Source ID: NCT01051011
Associated Drug: Insulin Glargine
Title: A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2
Interventions: DRUG: insulin glargine|DRUG: metformin|DRUG: taspoglutide|DRUG: taspoglutide
Outcome Measures: Primary: Glycemic control assessed by HbA1c, week 24 | Secondary: Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c, week 24|Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio), week 24|Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters, throughout study, laboratory assessments weeks 12, 24, 32 and 52|Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values, week 24
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 370
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-01
Completion Date: 2010-12
Results First Posted:
Last Update Posted: 2016-11-02
Locations: Beijing, 10029, China|Beijing, 100730, China|Beijing, 100853, China|Beijng, 100700, China|Chengdu, 610041, China|Chongqing, 400010, China|Guangzhou, 510120, China|Hangzhou, 310003, China|Hefei, 230022, China|Nanjing, 210006, China|Nanjing, 210036, China|Nanning, 530021, China|Shanghai, 200080, China|Shi Jiazhuang, 050051, China|Tianjin (天津), 300052, China|Tianjin, 201203, China|Hong Kong, Hong Kong|Busan, 614-735, Korea, Republic of|Daegu, 42472, Korea, Republic of|Daegu, 705-717, Korea, Republic of|Gyeonggi-do, 410-773, Korea, Republic of|Gyeonggi-do, 443-380, Korea, Republic of|Gyeonggi-do, 463-712, Korea, Republic of|Incheon, 405-760, Korea, Republic of|Kangwon-do, 220-701, Korea, Republic of|Kyounggi-do, 420-717, Korea, Republic of|Seoul, 0, Korea, Republic of|Seoul, 110-746, Korea, Republic of|Seoul, 130-702, Korea, Republic of|Seoul, 134-701, Korea, Republic of|Seoul, 135-720, Korea, Republic of|Seoul, 137-701, Korea, Republic of|Seoul, 139-872, Korea, Republic of|Johor Bahru, 80200, Malaysia|Kelantan, 16150, Malaysia|Kuala Lumpur, 50586, Malaysia|Kuala Lumpur, 50603, Malaysia|Penang, 10450, Malaysia|Putrajaya, 62250, Malaysia|Selangor, Malaysia|Cebu, 6000, Philippines|Iloilo, 5000, Philippines|Manila, 1000, Philippines|Manila, 1357, Philippines|Manila, 1503, Philippines|Pasig, 1605, Philippines|Chia-Yi City, 60002, Taiwan|Taichung, 404, Taiwan|Tainan, 710, Taiwan|Taipei, 00112, Taiwan|Taipei, 220, Taiwan|Taoyuan County, 333, Taiwan|Bangkok, 10330, Thailand|Bangkok, 10400, Thailand|Chiang Mai, 50200, Thailand|Nakhonratchasima, 30000, Thailand
URL: https://clinicaltrials.gov/show/NCT01051011

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details