Metformin SR Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes (CQM-2016)

July 22, 2019 updated by: Qifu Li, Chongqing Medical University

Comparison of Metformin Hydrochloride Sustained-release Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes

Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD is approved by China Food And Drug Administration (cFDA). Whether its efficacy and safety are equal to Glucophage is unclear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To perform a RCT for the comparison between Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD and Glucophage .

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Well informed of the procedures of this trial and informed consent is obtained
  2. Voluntarily accept standardized treatment 3.18-75 years old, gender is not limited

4.Newly diagnosed as type 2 diabetes and have not yet received any hypoglycemic therapy 5.Unable to control the blood glucose by diet and exercise: 7.5% ≤HbA1c ≤11.0%, in screening and before randomization 6.BMI: 19~35 kg/m2 7.Well compliance 8.Capable of self blood Glucose monitoring

Exclusion Criteria:

  1. Pregnant or lactating
  2. Type 1 diabetes
  3. Poor blood glucose control（HbA1c>11%）
  4. A history of malignant tumor
  5. Abnormal liver or renal function (defined as alanine aminotransferase(ALT)>2.5 times higher than normal range,or eGFR<45 mL/min per 1•73 m²)
  6. Poor blood pressure control [systolic blood pressure(SBP)>180mmHg,or diastolic blood pressure(DBP)>110mmHg]
  7. With severe heart disease,cardiac function worse than grade II,anemia(Hb<9.0g/d1)
  8. Continuous use of antidiabetic drugs more than one week in recent 3 months
  9. History of acute metabolic complications in recent 6 months
  10. Blood routine test indicates that the white blood cell count(WBC) <3*109/l
  11. Body Mass Index(BMI)<18.5 or ≥35kg/m2
  12. Drug or alcohol abuse
  13. Accompanying mental disorder who can't collaborate
  14. Abnormal digestion and absorption function
  15. Other endocrine diseases
  16. Other chronic diseases needed long-term glucocorticoid treatment
  17. With severe infection, immune dysfunction
  18. A history of metformin allergies or allergic constitution

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
Active Comparator: Metformin SR Tablet
Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD
Drug: Metformin SR Tablet
Metformin SR Tablet made in Conquer pharmaceutical co., LTD
Other Names:
  • DuLeNing
Active Comparator: Glucophage
The original drug of metformin
Drug: Metformin SR Tablet
Metformin SR Tablet made in Conquer pharmaceutical co., LTD
Other Names:
  • DuLeNing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of HbA1c
Time Frame: 12 weeks
Efficacy
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of nausea, diarrhea
Time Frame: 12 weeks
Safety
12 weeks
Changes of weight
Time Frame: 12 weeks
12 weeks
Changes of intestinal flora proportion
Time Frame: 12 weeks
12 weeks
Changes of LDL, HDL, TG, TC
Time Frame: 12 weeks
blood lipid
12 weeks

Collaborators and Investigators

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

Sponsor

Chongqing Medical University

Investigators

  • Principal Investigator: Qifu Li, 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 (Actual)

November 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQ-Metformin-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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