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

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chongqing Medical University
• Treatments: Metformin

Criteria

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