Impact of Benfluorex Versus Metformin on Glucose Control and Insulin Secretion in Chinese Type 2 Diabetic Patients
Recruitment status was: Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
- The change of HbA1c from baseline to the end of treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- the changes of fasting and after standard meal glucose and insulin level and plasma lipid level [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||October 2008|
|Estimated Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
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.
|Active Comparator: 1||
2 tablets with breakfast and dinner for the first four weeks, if necessary, increase 2 tablets with noon for the next time
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544518
|XiJing hospital of Fourth Military Medical University|
|Xi'an, Shanxi, China, 710032|
|Principal Investigator:||Ji qiuhe, Ph.D||Fourth Military Medical University|