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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Fourth Military Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Shandong Xinhua Pharmaceutical Company Limited in China
Beijing Haijinge medicine Science-tech CO.,LTD(CRO)
Center for Drug Clincal Reserch Shanghai University of TCM
Beijing Army General Hospital
Bethune International Peace Hospital
The People's Hospital of Hebei Province
Second Hospital of Jilin University
Information provided by:
Fourth Military Medical University
ClinicalTrials.gov Identifier:
NCT00544518
First received: October 15, 2007
Last updated: May 21, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: metformin
Drug: benfluorex
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Fourth Military Medical University:

Primary Outcome Measures:
  • The change of HbA1c from baseline to the end of treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544518

Locations
China, Shanxi
XiJing hospital of Fourth Military Medical University
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Shandong Xinhua Pharmaceutical Company Limited in China
Beijing Haijinge medicine Science-tech CO.,LTD(CRO)
Center for Drug Clincal Reserch Shanghai University of TCM
Beijing Army General Hospital
Bethune International Peace Hospital
The People's Hospital of Hebei Province
Second Hospital of Jilin University
Investigators
Principal Investigator: Ji qiuhe, Ph.D Fourth Military Medical University
  More Information

No publications provided

Responsible Party: the clinical trial center, Xijing Hospital, The fourth military medical university
ClinicalTrials.gov Identifier: NCT00544518     History of Changes
Other Study ID Numbers: bfls071012
Study First Received: October 15, 2007
Last Updated: May 21, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Fourth Military Medical University:
type 2 diabetes
Benfluorex
Metformin
insulin secretion
glucose control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Benfluorex
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014