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Completed

NCT Number: NCT03039075

Metformin SR 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Well informed of the procedures of this trial and informed consent is obtained
  • 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

  • Pregnant or lactating
  • Type 1 diabetes
  • Poor blood glucose control(HbA1c>11%)
  • A history of malignant tumor
  • 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)
  • Poor blood pressure control [systolic blood pressure(SBP)>180mmHg,or diastolic blood pressure(DBP)>110mmHg]
  • With severe heart disease,cardiac function worse than grade II,anemia(Hb<9.0g/d1)
  • Continuous use of antidiabetic drugs more than one week in recent 3 months
  • History of acute metabolic complications in recent 6 months
  • Blood routine test indicates that the white blood cell count(WBC) <3*109/l
  • Body Mass Index(BMI)<18.5 or ≥35kg/m2
  • Drug or alcohol abuse
  • Accompanying mental disorder who can't collaborate
  • Abnormal digestion and absorption function
  • Other endocrine diseases
  • Other chronic diseases needed long-term glucocorticoid treatment
  • With severe infection, immune dysfunction
  • A history of metformin allergies or allergic constitution

Treatment and study plan

Metformin SR Tablet

Drug

Metformin SR Tablet made in Conquer pharmaceutical co., LTD

Other names: DuLeNing

Primary outcomes

  1. Changes of HbA1c

    Time frame: 12 weeks

    Efficacy

Secondary outcomes

  1. Incidence of nausea, diarrhea

    Time frame: 12 weeks

    Safety

  2. Changes of weight

    Time frame: 12 weeks

  3. Changes of intestinal flora proportion

    Time frame: 12 weeks

  4. Changes of LDL, HDL, TG, TC

    Time frame: 12 weeks

    blood lipid

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

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

Acronym: CQM-2016

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2017
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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