Ignite Creation Date:
2024-05-06 @ 8:41 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02798172
Status:
COMPLETED
Last Update Posted:
2016-06-14
First Post:
2016-05-30
Brief Title:
The Effect of Alogliptin on Pulmonary Function in Obese Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy
Sponsor:
Fourth Peoples Hospital of Shenyang
Organization:
Fourth Peoples Hospital of Shenyang
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To observe the effect of alogliptin combined with metformin on pulmonary function in obese patients with type 2 diabetes inadequately controlled by metformin monotherapy 500 mg bid po for at least 3 months and evaluate its efficacy and safety
Method After a 2-week screening period adult patients aged 36-72 years entered a 4-week run-instabilization period Then patients were randomly assigned to either the intervention group n55 or control group n50 for 26 weeks The patients in the control group were given metformin 1000 mg bid po and the patients in the intervention group were given metformin 500 mg bid po combined with alogliptin 25 mg qd po All the patients received counseling about diet and exercise from a nutritionist during run-in and treatment periods
The primary endpoints were the between-group differences in the changes pulmonary function parameters VC FVC FEV1 PEF MVV TLC FEV1FVC DLCO and DLCOVA between pretherapy and posttreatment The secondary endpoints were changes from baseline to week 26 in HbA1c FPG 2hPG HOMA-IR WC and BMI The tertiary endpoints were the changes from baseline to week 26 in blood-fat TC HDL-C LDL-C and TG The quartus endpoints were the changes from baseline to week 26 in SBP and DBP The fifth endpoints were the changes from baseline to week 26 in oxidativeantioxidative parameters ROS MDA SOD and GSH-PX In addition safety endpoints were assessed AEs clinical laboratory tests vital signs and electrocardiographic readings
Method After a 2-week screening period adult patients aged 36-72 years entered a 4-week run-instabilization period Then patients were randomly assigned to either the intervention group n55 or control group n50 for 26 weeks The patients in the control group were given metformin 1000 mg bid po and the patients in the intervention group were given metformin 500 mg bid po combined with alogliptin 25 mg qd po All the patients received counseling about diet and exercise from a nutritionist during run-in and treatment periods
The primary endpoints were the between-group differences in the changes pulmonary function parameters VC FVC FEV1 PEF MVV TLC FEV1FVC DLCO and DLCOVA between pretherapy and posttreatment The secondary endpoints were changes from baseline to week 26 in HbA1c FPG 2hPG HOMA-IR WC and BMI The tertiary endpoints were the changes from baseline to week 26 in blood-fat TC HDL-C LDL-C and TG The quartus endpoints were the changes from baseline to week 26 in SBP and DBP The fifth endpoints were the changes from baseline to week 26 in oxidativeantioxidative parameters ROS MDA SOD and GSH-PX In addition safety endpoints were assessed AEs clinical laboratory tests vital signs and electrocardiographic readings
Detailed Description:
Alogliptin was provided by Takeda Chemical industries Ltd in Japan trade name Nesina 25 mgtablet Metformin was provided by Bristol Myers Squibb in America trade name Glucophage 500 mgtablet Research kits for ROS MDA and SOD GSH-PX were provided by Nanjing Jiancheng Bioengineering Institute in China Research kits for TC HDL-C HDL-C and TG were provided by were provided by Nanjing Jiancheng Bioengineering Institute in China The spirometer used for pulmonary function tests was provided by Jaska Corporation in Japan model number HI-101
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None