Efficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment

January 26, 2016 updated by: Qifu Li

Efficacy/Safety Study of Adding Glimepiride to Type 2 Diabetes Patients With Inadequate Glycemic Control Based on Combination With Metformin And Basal Insulin

All the guidelines suggest that metformin as the basis of type 2 diabetes medication, and evidence is sufficient.At the same time the basal insulin injection once a day are more and more widely used in diabetes patients in China.

This study aims to evaluate the efficacy and safety of adding glimepiride to type 2 diabetes patients with inadequate glycemic control with combined therapy of metformin and basal insulin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing,, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Understand the whole test process, voluntary and signed informed consent form
  • Men and women aged 35 to 70 years old
  • 20≤BMI<35 Kg/m2
  • Diagnosed with type 2 diabetes
  • Undergoing metformin(Dose not less than 1000 mg/day)in combination with basal insulin injection once a day
  • HbA1c7.0-11%
  • Patients should be able to self blood glucose monitoring

Exclusion Criteria:

  • sulfonylureas,glinides,TZDs use within 3 months before the study
  • Pregnant or lactating women
  • A history of ketoacidosis
  • Allergy to sulfonylureas or sulfa drug patients
  • Apparent dysfunction of liver and kidney patients(ALT>2 times upper normal limit,serum creatinine>1.2 times upper normal limit)
  • Poor blood pressure control(systolic pressure>180mmHg or diastolic blood pressure>110mmHg)
  • heart disease,cardiac insufficiency,unstable angina pectoris,ECG indicates left ventricle hypertrophy,severe anemia(Hb<9.0g/d1)
  • Severe diabetic nerve complications(ulcer of lower limb,neurogenic bladder)
  • BMI<20 orBMI≥35kg/m2
  • Alcohol or drug abuse ,or can't collaborate due to mental disorder
  • Digestion and absorption function obstacle or Other endocrine disorders
  • Other chronic diseases required long-term glucocorticoid treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: glimepiride
on the basis of metformin and glargine, the initial dose of glimepiride is 2 mg,qd (before breakfast), and adjust the dosage for fasting plasma glucose, dosage-adding indicator is the FPG≥7.2, maximum dose of glimepiride is 4 mg/d per day.
Drug: glimepiride
on the basis of metformin and glargine, glimepiride is added; with the maximun dose of glimepiride, if the targeted FPG is not reached, glargine dose will be increased.
Drug: glargine and metformin
Other Names:
  • lantus
Active Comparator: Metformin and glargine
on the basis of Metformin and glargine,no glempiride addition. dose of glargine was adjust according to the FPG, with the target less than 7.2mmol/l
Drug: glargine and metformin
Other Names:
  • lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24 weeks after treatment, HbA1c values' change compared with baseline
Time Frame: 24 weeks after treatment
24 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
hypoglycemia events
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qifu Li

Investigators

  • Study Chair: Li Qifu, PhD, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 26, 2013

First Submitted That Met QC Criteria

December 31, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yml2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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