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CompletedNCT03039075CQM-2016Updated Jul 24, 2019

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

A Phase 4 interventional study of Metformin SR Tablet in Diabetes Mellitus, sponsored by Chongqing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-24.

Sponsored by Chongqing Medical University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 240 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Chongqing Medical University is the lead sponsor of 75 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • Active comparator
    Metformin SR Tablet

    Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD

    Drug: Metformin SR Tablet

  • Active comparator
    Glucophage

    The original drug of metformin

    Drug: Metformin SR Tablet

Interventions

  • DrugMetformin SR Tablet

    Metformin SR Tablet made in Conquer pharmaceutical co., LTD

    Also known as: DuLeNing

06

What researchers measure

Primary outcomes

  1. Changes of HbA1c

    Efficacy

    Time frame: 12 weeks

Secondary outcomes

  1. Incidence of nausea, diarrhea

    Safety

    Time frame: 12 weeks

  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

    blood lipid

    Time frame: 12 weeks

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Study locations

1 site
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing 400016, China
08

References and documents

Publications

  • Buse JB, DeFronzo RA, Rosenstock J, Kim T, Burns C, Skare S, Baron A, Fineman M. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies. Diabetes Care. 2016 Feb;39(2):198-205. doi: 10.2337/dc15-0488. Epub 2015 Aug 18. PubMed 26285584 ↗
  • Xu T, Brandmaier S, Messias AC, Herder C, Draisma HH, Demirkan A, Yu Z, Ried JS, Haller T, Heier M, Campillos M, Fobo G, Stark R, Holzapfel C, Adam J, Chi S, Rotter M, Panni T, Quante AS, He Y, Prehn C, Roemisch-Margl W, Kastenmuller G, Willemsen G, Pool R, Kasa K, van Dijk KW, Hankemeier T, Meisinger C, Thorand B, Ruepp A, Hrabe de Angelis M, Li Y, Wichmann HE, Stratmann B, Strauch K, Metspalu A, Gieger C, Suhre K, Adamski J, Illig T, Rathmann W, Roden M, Peters A, van Duijn CM, Boomsma DI, Meitinger T, Wang-Sattler R. Effects of metformin on metabolite profiles and LDL cholesterol in patients with type 2 diabetes. Diabetes Care. 2015 Oct;38(10):1858-67. doi: 10.2337/dc15-0658. Epub 2015 Aug 5. PubMed 26251408 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03039075
Lead sponsor
Chongqing Medical University
Responsible party
Qifu Li (Primary Investigator, Chongqing Medical University) — Principal investigator
First posted
Feb 1, 2017
Start date
Nov 2016
Primary completion
Oct 2018
Completion
Nov 2018
Last update
Jul 24, 2019

Study contacts

Qifu Li, phD
principal investigator · First Affiliated Hospital of Chongqing Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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