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

NCT00544518 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2008-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

metformin

2 tablets with breakfast and dinner for the first four weeks, if necessary, increase 2 tablets with noon for the next time

DRUG

benfluorex

2 tablets with breakfast and dinner for the first four weeks, if necessary, increase 2 tablets with noon for the next time, one of 2 tablets is dummy tablet.

Sponsors & Collaborators

  • Shandong Xinhua Pharmaceutical Company Limited in China

    collaborator UNKNOWN

  • Beijing Haijinge medicine Science-tech CO.,LTD(CRO)

    collaborator UNKNOWN

  • Center for Drug Clincal Reserch Shanghai University of TCM

    collaborator OTHER

  • Beijing Army General Hospital

    collaborator OTHER_GOV

  • Bethune International Peace Hospital

    collaborator OTHER

  • The People's Hospital of Hebei Province

    collaborator OTHER

  • Second Hospital of Jilin University

    collaborator OTHER

  • Air Force Military Medical University, China

    lead OTHER

Principal Investigators

  • Ji qiuhe, Ph.D · Air Force Military Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-09-30
Completion
2008-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00544518 on ClinicalTrials.gov