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

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 Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: benfluorex; Drug: metformin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Xijing Hospital of Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	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.
Active Comparator: 1	Drug: metformin; 2 tablets with breakfast and dinner for the first four weeks, if necessary, increase 2 tablets with noon for the next time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of HbA1c from baseline to the end of treatment	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
the changes of fasting and after standard meal glucose and insulin level and plasma lipid level	16 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Anticipated): September 1, 2008
• Study Completion (Anticipated): October 1, 2008

Study Registration Dates

• First Submitted: October 15, 2007
• First Submitted That Met QC Criteria: October 15, 2007
• First Posted (Estimate): October 16, 2007

Study Record Updates

• Last Update Posted (Estimate): May 22, 2008
• Last Update Submitted That Met QC Criteria: May 21, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Metformin; type 2 diabetes; glucose control; insulin secretion; Benfluorex
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Appetite Depressants; Anti-Obesity Agents; Metformin; Benfluorex
• Other Study ID Numbers: bfls071012