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

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

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Metformin SR Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin SR Tablet<br>Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD | Drug: Metformin SR Tablet<br>* Metformin SR Tablet made in Conquer pharmaceutical co., LTD<br>* Other names: DuLeNing;|
| Active Comparator: Glucophage<br>The original drug of metformin | Drug: Metformin SR Tablet<br>* Metformin SR Tablet made in Conquer pharmaceutical co., LTD<br>* Other names: DuLeNing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of HbA1c | Efficacy | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nausea, diarrhea | Safety | 12 weeks | 
| Changes of weight |  | 12 weeks | 
| Changes of intestinal flora proportion |  | 12 weeks | 
| Changes of LDL, HDL, TG, TC | blood lipid | 12 weeks |