The Effect of Alogliptin on Pulmonary Function in Obese Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy

NCT02798172 | Completed

• 1 other identifier: 20140508
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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-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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 Outcomes (1)

• The changes of BMI from baseline to week 26 in intervention group (n=44) and control group (n=37).

  26 weeks

Study Arms (2)

Alogliptin+metformin

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

Alogliptin and Metformin DRUG

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)

Alogliptin+metformin; metformin

Eligibility Criteria

• Age: 36 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

Sponsors & Collaborators

• Fourth People's Hospital of Shenyang: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alogliptin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 14, 2016
• Study Start: May 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 14, 2016

Record last verified: 2016-06