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Clinical Trial Details

Trial ID: L2927
Source ID: NCT02798172
Associated Drug: Alogliptin And Metformin
Title: The Effect of Alogliptin on Pulmonary Function in Obese Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Alogliptin and Metformin
Outcome Measures: Primary: The primary endpoints were changes from baseline to week 26 in pulmonary function parameters [VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%] between pretherapy and posttreatment., 26 weeks | Secondary: The secondary endpoints were changes from baseline to week 26 in HbA1c in intervention group (n=44) and control group (n=37)., 26 weeks|The tertiary endpoints were the changes from baseline to week 26 in blood-fat (TC, HDL-C, LDL-C, and TG) in the intervention group (n=44) and control group (n=37)., 26 weeks|The fourth endpoints were the changes from baseline to week 26 in FPG, 2hPG in the intervention group (n=44) and control group (n=37)., 26 weeks|The fourth endpoints were the changes from baseline to week 26 in oxidative/antioxidative parameters (ROS, MDA, SOD, and GSH-PX) in the intervention group (n=44) and control group (n=37)., 26 weeks|In addition, safety endpoints were assessed (AEs, clinical laboratory tests, vital signs, and electrocardiographic readings), 26 weeks | Other: The changes of BMI from baseline to week 26 in intervention group (n=44) and control group (n=37)., 26 weeks
Sponsor/Collaborators: Sponsor: Fourth People's Hospital of Shenyang
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 81
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-05
Completion Date: 2015-08
Results First Posted:
Last Update Posted: 2016-06-14
Locations:
URL: https://clinicaltrials.gov/show/NCT02798172