An interventional study of Alogliptin and Metformin in Diabetes Mellitus, Type 2, sponsored by Fourth People's Hospital of Shenyang. Completed. Open to participants aged 36 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-14.
Sponsored by Fourth People's Hospital of Shenyang · Not applicable, Interventional, and Treatment
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
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 81 is close to the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Fourth People's Hospital of Shenyang is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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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Alogliptin (alogliptin benzoate) is the most recent DPP-4 inhibitor; it entered the market in 2006. It is a potent and highly selective DPP-4 inhibitor with oral antidiabetic activity; Metformin is the most commonly prescribed first-line drug worldwide for the treatment of T2DM, it acts by decreasing both hepatic glucose production and intestinal glucose absorption, while improving insulin sensitivity, metformin as a safe and valid oral antidiabetic drug was recommended to the obese patients with a body mass index (BMI) \>30 kg/m2, it has some value in reducing or preventing weight gain and changes in metabolic parameters during treatment, and it can be combinated with other antidiabetic drug
Drug: Alogliptin and Metformin
Metformin is the most commonly prescribed first-line drug worldwide for the treatment of T2DM, it acts by decreasing both hepatic glucose production and intestinal glucose absorption, while improving insulin sensitivity, metformin as a safe and valid oral antidiabetic drug was recommended to the obese patients with a body mass index (BMI) \>30 kg/m2, it has some value in reducing or preventing weight gain and changes in metabolic parameters during treatment, and it can be combinated with other antidiabetic drug
Drug: Alogliptin and Metformin
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)
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.
Time frame: 26 weeks
The secondary endpoints were changes from baseline to week 26 in HbA1c in intervention group (n=44) and control group (n=37).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 26 weeks
In addition, safety endpoints were assessed (AEs, clinical laboratory tests, vital signs, and electrocardiographic readings)
Time frame: 26 weeks
The changes of BMI from baseline to week 26 in intervention group (n=44) and control group (n=37).
Time frame: 26 weeks
No study locations are listed for this record.
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Fourth People's Hospital of Shenyang