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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-11-30

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.

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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 .

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin SR Tablet

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

Group Type ACTIVE_COMPARATOR

Metformin SR Tablet

Intervention Type DRUG

Metformin SR Tablet made in Conquer pharmaceutical co., LTD

Glucophage

The original drug of metformin

Group Type ACTIVE_COMPARATOR

Metformin SR Tablet

Intervention Type DRUG

Metformin SR Tablet made in Conquer pharmaceutical co., LTD

Interventions

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Metformin SR Tablet

Metformin SR Tablet made in Conquer pharmaceutical co., LTD

Intervention Type DRUG

Other Intervention Names

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DuLeNing

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No