The Effect of Alogliptin on Pulmonary Function in Obese Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy
The Effect of Alogliptin on Pulmonary Function in Obese Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy
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-in/stabilization period. Then, patients were randomly assigned to either the intervention
 group (n=55) or control group (n=50) for 26 weeks. The patients in the control group were
 given metformin (1,000 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%, FEV1/FVC%, DLCO%, and DLCO/VA%] 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 oxidative/antioxidative parameters (ROS, MDA, SOD, and GSH-PX). In
 addition, safety endpoints were assessed (AEs, clinical laboratory tests, vital signs, and
 electrocardiographic readings).
Alogliptin was provided by Takeda Chemical industries Ltd in Japan, trade name: Nesina, 25
 mg/tablet. Metformin was provided by Bristol Myers Squibb in America, trade name: Glucophage,
 500 mg/tablet. 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
Inclusion Criteria:

 -  1) Aged from 36 to 72 years of either gender; 2) BMI >28.0 kg/m2, and WC >90 cm
 (male), or WC >85 cm (female); 3) The patients were diagnosed with T2DM and the
 serological outcome (7.0%<HbA1c<10.0%) did not reach the therapeutic targets and oral
 metformin monotherapy (500 mg, bid po, ≥3 months prior to screening); 4) No smoking
 history, pulmonary disease nor pulmonary infection within a fortnight; 5) Did not have
 hepatopathy, nephropathy and gastrointestinal disease; and 6) Likely to have good
 compliance and able to visit our hospital for periodic assessments.

 Exclusion Criteria:1) T1DM, gestation and lactation; 2) Renal inadequacy; 3) hypohepatia;
 4) Intensive care with insulin treatment; 5) Intolerance to alogliptin and metformin; 6)
 Heart failure; 7) Had received antidiabetic agents; 8) Antihypertensive drugs can not
 control the BP adequately or severe uncontrolled hypertension; 9) Cholesterol-lowering
 drugs can not control the blood-fat adequately; and 10) Use of weight loss drugs.

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