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
During the whole study, patients meet a physician on a regular basis. Safety is assessed by adverse event spontaneous reporting、physical examination、recording of vital signs、laboratory tests and electrocardiogram at baseline and 16 week . Blood samples are collected for centralized measure of HbA1C and fasting serum insulin(FSI)、PSI1/2、PSI2 after an overnight fast in all patients,Body weight, supine and standing blood pressures and heart rate are measured at each clinical visit. Adverse events are rated as mild, moderate or severe by the investigators and assessed for any causal relationship to the study drugs. Patients are entitled to interrupt the treatment at any time during the study, and investigators can withdraw patients, in particular if they are inadequately controlled.
|XiJing hospital of Fourth Military Medical University|
|Xi'an, Shanxi, China, 710032|
|Principal Investigator:||Ji qiuhe, Ph.D||Fourth Military Medical University|