Impact of Benfluorex Versus Metformin on Glucose Control and Insulin Secretion in Chinese Type 2 Diabetic Patients

• Status: Unknown status
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Objective--- Benfluorex may have effects on the glucose control in type 2 diabetes while it improves hyperlipidemia. We sought to compare the impacts of benfluorex versus metformin on glucose control and insulin secretion in Chinese type 2 diabetic patients.

Research design and methods---a 16-week, double-blind, multiple centers, random parallel controlled study is designed to compare the impact of benfluorex (150-450mg/day, provided by Shandong Xinhua Pharmaceutical Company Limited in China) on glucose control, insulin secretion and its safety with metformin in type 2 diabetic patients. 240 type 2 diabetic patients are to be recruited to receive benfluorex or metformin(1:1). HbA1c, plasma lipid level, insulin and glucose at 0', 30', 120' after a standard meal will be measured before and after treatment, while fasting and postprandial glucose measured 4 times regularly. The change of HbA1c from baseline to the end of treatment will taken as main efficacy criterion, as the changes of fasting and after standard meal glucose and insulin level and plasma lipid level will be taken as secondary criteria. All patient will be given safety monitor at prior and post treatment. Data management and statistical analysis will adopt DAS for Clinical Trial 2.0.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Force Military Medical University, China; Fourth Military Medical University
• Collaborators: Beijing Army General Hospital; Beijing Haijinge medicine Science-tech CO.,LTD(CRO); Bethune International Peace Hospital; Center for Drug Clincal Reserch Shanghai University of TCM; Second Hospital of Jilin University; Shandong Xinhua Pharmaceutical Company Limited in China; The People's Hospital of Hebei Province
• Treatments: Benfluorex; Fenfluramine; Metformin

Criteria

Inclusion Criteria:

• For inclusion in the study, participants will be；① Antidiabetic drugs naïve Type 2 diabetes mellitus（WHO standard） with diet control more than 2 weeks; ②or diagnosed Type 2 diabetes mellitus with no oral antidiabetic drugs more than 6months; ③or Type 2 diabetes mellitus treated with insulin secretagogues more than 1 month; all patients have HbA1c between 7.0-10.0% and fasting glucose between 7.0mmol/L～13.0mmol/L.

• Ages Eligible for Study: 18 Years --70 Years, Genders:Both

• BMI: 23～40kg/m2

• No using insulin before 3 months

• Consent to do birth control to Women of child-bearing age

• Volunteer to join and sign Information consent form

Exclusion Criteria:

• Patients with ketoacidosis、hyperglycemic hyperosmolar syndrome.

• Patients with severe diabetic complications

• Patient with acute cardiovascular diseases，acute cerebrovascular diseases，with Vitamin B12、folic acid and iron deficiency，with severe trauma or surgery，severe infection diseases.

• Allergy to benfluorex or metformin

• ALT、AST> 2 times of upper normal limit，Cr> upper normal limit.

• Having used benfluorex within 3 months before recruiting.

• Patients accepting steroid hormones or malignant tumor treatment

• Patients with drug abuse or bibulous history.

• Patients with severe unconscious low blood glucose history，severe mental illness history and family history

• Severe hypertensive patients（SBP>160 mmHg，DBP>95mmHg）

• Patient with pancreas diseases.