Metformin SR Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes (CQM-2016)

Chongqing Medical University

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Metformin SR Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03039075

CQ-Metformin-2016

Details and patient eligibility

About

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.

Full description

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

Enrollment: 240 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 2 patient groups

Metformin SR Tablet

Active Comparator group

Description:

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

Treatment:

Drug: Metformin SR Tablet

Glucophage

Active Comparator group

Description:

The original drug of metformin

Treatment:

Drug: Metformin SR Tablet