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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
metformin
benfluorex
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes, Benfluorex, Metformin, insulin secretion, glucose control

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • XiJing hospital of Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2

1

Arm Description

Outcomes

Primary Outcome Measures

The change of HbA1c from baseline to the end of treatment

Secondary Outcome Measures

the changes of fasting and after standard meal glucose and insulin level and plasma lipid level

Full Information

First Posted
October 15, 2007
Last Updated
May 21, 2008
Sponsor
Air Force Military Medical University, China
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
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1. Study Identification

Unique Protocol Identification Number
NCT00544518
Brief Title
Impact of Benfluorex Versus Metformin on Glucose Control and Insulin Secretion in Chinese Type 2 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Anticipated)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Air Force Military Medical University, China
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes, Benfluorex, Metformin, insulin secretion, glucose control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Title
1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
2 tablets with breakfast and dinner for the first four weeks, if necessary, increase 2 tablets with noon for the next time
Intervention Type
Drug
Intervention Name(s)
benfluorex
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of HbA1c from baseline to the end of treatment
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
the changes of fasting and after standard meal glucose and insulin level and plasma lipid level
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji qiuhe, Ph.D
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
XiJing hospital of Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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

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