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

NCT00544518 | Unknown Phase 2 DMC

• 1 other identifier: bfls071012
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; Benfluorex; Metformin; insulin secretion; glucose control

Outcome Measures

Primary Outcomes (1)

• The change of HbA1c from baseline to the end of treatment

  16 weeks

Secondary Outcomes (1)

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

  16 weeks

Study Arms (2)

2

EXPERIMENTAL

Drug: benfluorex

1

ACTIVE COMPARATOR

Drug: metformin

Interventions

metformin DRUG

2 tablets with breakfast and dinner for the first four weeks, if necessary, increase 2 tablets with noon for the next time

1

benfluorex DRUG

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.

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

XiJing hospital of Fourth Military Medical University

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; benfluorex

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Ji qiuhe, Ph.D

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 16, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 22, 2008

Record last verified: 2008-05

Locations

CN (1)