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Clinical Trial Details

Trial ID: L4995
Source ID: NCT02855684
Associated Drug: Insulin Glargine (U300)
Title: Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy
Acronym: EDITION AP
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Insulin glargine (U300)|DRUG: Insulin glargine|DRUG: Non-insulin antihyperglycemic drugs
Outcome Measures: Primary: Change in HbA1c from baseline, Baseline, 6 months | Secondary: Percentage (%) of patients with at least one hypoglycemia, Baseline, up to 6 months|Percentage (%) of patients with at least one nocturnal hypoglycemia, Baseline, up to 6 months|Percentage (%) of patients with HbA1c <7.0%, 6 months|Percentage (%) of patients with HbA1c ≤6.5%, 6 months|Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L), 6 months|Percentage (%) of patients with FPG ≤120 mg/dL (6.7 mmol/L), 6 months|Percentage (%) of patients requiring rescue therapy, 6 months|Change in fasting plasma glucose, Baseline, 6 months|Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles, Baseline, 6 months|Change of mean 24-hour plasma glucose, Baseline, 6 months|Change in variability of plasma glucose profile, Baseline, 6 months|Change in daily basal insulin dose, Baseline, 6 months
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 604
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-08-24
Completion Date: 2018-08-06
Results First Posted:
Last Update Posted: 2022-04-25
Locations: Investigational Site Number 1560039, Beijing, 100034, China|Investigational Site Number 1560001, Beijing, 100044, China|Investigational Site Number 1560017, Beijing, 100191, China|Investigational Site Number 1560003, Beijing, 100730, China|Investigational Site Number 1560033, Changchun, 130021, China|Investigational Site Number 1560016, Changzhou, 213003, China|Investigational Site Number 1560049, Changzhou, 213003, China|Investigational Site Number 1560006, Fuzhou, 354200, China|Investigational Site Number 1560004, Guangzhou, 510080, China|Investigational Site Number 1560036, Guangzhou, 510080, China|Investigational Site Number 1560043, Guangzhou, 510120, China|Investigational Site Number 1560014, Guangzhou, 510515, China|Investigational Site Number 1560042, Guiyang, 550004, China|Investigational Site Number 1560024, Hangzhou, 310015, China|Investigational Site Number 1560046, Hefei, 230001, China|Investigational Site Number 1560025, Hohhot, 010017, China|Investigational Site Number 1560019, Jinan, 250013, China|Investigational Site Number 1560027, Lanzhou, 730000, China|Investigational Site Number 1560038, Nanchang, 330006, China|Investigational Site Number 1560045, Nanchang, 330006, China|Investigational Site Number 1560002, Nanjing, 210008, China|Investigational Site Number 1560012, Nanjing, 210011, China|Investigational Site Number 1560047, Nanjing, 210029, China|Investigational Site Number 1560021, Shanghai, 200040, China|Investigational Site Number 1560018, Shanghai, 200240, China|Investigational Site Number 1560048, Shenyang, 110004, China|Investigational Site Number 1560005, Shenyang, 110022, China|Investigational Site Number 1560020, Shenzhen, 518036, China|Investigational Site Number 1560013, Siping, 136000, China|Investigational Site Number 1560031, Tangshan, 063000, China|Investigational Site Number 1560023, Tianjin, 300052, China|Investigational Site Number 1560044, Tianjin, 300121, China|Investigational Site Number 1560009, Xi'An, 710061, China|Investigational Site Number 1560034, Xiamen, 361003, China|Investigational Site Number 1560010, Xuzhou, 221002, China|Investigational Site Number 1560026, Yueyang, 414000, China|Investigational Site Number 1560011, Zhengzhou, 450052, China|Investigational Site Number 1560030, Zhenjiang, 212001, China|Investigational Site Number 1560041, Zhuzhou, 412007, China|Investigational Site Number 4100003, Anyang, 431-070, Korea, Republic of|Investigational Site Number 4100005, Busan, 602-739, Korea, Republic of|Investigational Site Number 4100010, Gwangju, 61453, Korea, Republic of|Investigational Site Number 4100012, Gyeonggi-Do, 11923, Korea, Republic of|Investigational Site Number 4100008, Seoul, 01830, Korea, Republic of|Investigational Site Number 4100001, Seoul, 03181, Korea, Republic of|Investigational Site Number 4100009, Seoul, 06351, Korea, Republic of|Investigational Site Number 4100004, Seoul, 110-744, Korea, Republic of|Investigational Site Number 4100006, Seoul, 120-752, Korea, Republic of|Investigational Site Number 4100007, Seoul, 138-878, Korea, Republic of|Investigational Site Number 4100002, Wonju, 26426, Korea, Republic of|Investigational Site Number 1580001, Taichung, 40447, Taiwan|Investigational Site Number 1580004, Taipei, 104, Taiwan|Investigational Site Number 1580003, Taipei, 11031, Taiwan|Investigational Site Number 1580002, Taipei, 220, Taiwan
URL: https://clinicaltrials.gov/show/NCT02855684

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