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

Diabetes Mellitus Clinical Trial

— CQM-2016  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039075
• Other study ID #: CQ-Metformin-2016
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: July 2019
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Metformin SR Tablet
Metformin SR Tablet made in Conquer pharmaceutical co., LTD

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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, Kastenmüller G, Willemsen G, Pool R, Kasa K, van Dijk KW, Hankemeier T, Meisinger C, Thorand B, Ruepp A, Hrabé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of HbA1c	Efficacy	12 weeks
Secondary	Incidence of nausea, diarrhea	Safety	12 weeks
Secondary	Changes of weight		12 weeks
Secondary	Changes of intestinal flora proportion		12 weeks
Secondary	Changes of LDL, HDL, TG, TC	blood lipid	12 weeks