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Clinical Trial Details

Trial ID: L3277
Source ID: NCT02280486
Associated Drug: Saxagliptin
Title: Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin
Acronym: SPECIFY
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Glimepiride
Outcome Measures: Primary: Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7.0%, Compare the proportion of subjects after 48-week treatment achieving HbA1c\<7.0%, with no hypoglycemia and no body weight gain (defined as glucose \< 3.9 mmol/L with or without symptoms and weight gain \< 3.0%)., Change from Baseline after 48 weeks treatment | Secondary: The change in blood glucose fluctuations of subjects., 30 subjects of each group would be randomly chosen to evaluate blood glucose fluctuations by continuous glucose monitoring system (CGMS) before and after 48 weeks treatment., Change from Baseline after 48 weeks treatment|The improvement in beta-cell function of subjects, All subjects would be tested in fasting proinsulin, proinsulin/insulin ratio, true insulin and C-peptide during standard meal test (75-gram instant noodles) before and after 48 weeks treatment., Change from Baseline after 48 weeks treatment|The change in body composition of subjects., All subjects would be measured by their weight (WT), body mass index (BMI) and waist-hip ratio (WHR) every four weeks until the end of 48 weeks treatment., Change from Baseline after 48 weeks treatment|Safety and tolerability of saxagliptin vs. glimepiride measured by adverse events, serious adverse events (SAEs); laboratory assessments (biochemistry, lipids, blood and urine routine tests, The proportion of AEs and SAEs would be measured.Incidence of hypoglycemia episodes (defined as symptoms with glucose \< 3.1 mmol/L);adverse events (AEs);serious adverse events (SAEs);laboratory assessments (biochemistry, lipids, blood and urine routine tests);other safety and tolerability parameters (ECG, vital signs, physical examination)., Change from Baseline after 48 weeks treatment
Sponsor/Collaborators: Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Collaborators: The First Affiliated Hospital with Nanjing Medical University|Zhongda Hospital|Nanjing PLA General Hospital|Changzhou No.2 People's Hospital|The First Affiliated Hospital of Soochow University|Wuxi People's Hospital|The First Affiliated Hospital of Anhui Medical University|Huai'an First People's Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 388
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-01
Completion Date: 2017-10
Results First Posted:
Last Update Posted: 2018-07-23
Locations: at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, 210008, China
URL: https://clinicaltrials.gov/show/NCT02280486