Diabetes Mellitus
Conditions
Brief 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.
Detailed description
To perform a RCT for the comparison between Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD and Glucophage .
Interventions
DRUGMetformin SR Tablet
Metformin SR Tablet made in Conquer pharmaceutical co., LTD
Sponsors
Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of HbA1c | 12 weeks | Efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of nausea, diarrhea | 12 weeks | Safety |
| Changes of weight | 12 weeks | — |
| Changes of intestinal flora proportion | 12 weeks | — |
| Changes of LDL, HDL, TG, TC | 12 weeks | blood lipid |
Countries
China
Outcome results
None listed