Clinical trial NCT03039075: Metformin SR Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes
Official title: Comparison of Metformin Hydrochloride Sustained-release Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility 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

Primary outcomes:
measure: Changes of HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of nausea, diarrhea
timeFrame: 12 weeks
measure: Changes of weight
timeFrame: 12 weeks
measure: Changes of intestinal flora proportion
timeFrame: 12 weeks
measure: Changes of LDL, HDL, TG, TC
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Qifu Li, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buse JB, DeFronzo RA, Rosenstock J, Kim T, Burns C, Skare S, Baron A, Fineman M. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies. Diabetes Care. 2016 Feb;39(2):198-205. doi: 10.2337/dc15-0488. Epub 2015 Aug 18.
citation: Xu T, Brandmaier S, Messias AC, Herder C, Draisma HH, Demirkan A, Yu Z, Ried JS, Haller T, Heier M, Campillos M, Fobo G, Stark R, Holzapfel C, Adam J, Chi S, Rotter M, Panni T, Quante AS, He Y, Prehn C, Roemisch-Margl W, Kastenmuller G, Willemsen G, Pool R, Kasa K, van Dijk KW, Hankemeier T, Meisinger C, Thorand B, Ruepp A, Hrabe de Angelis M, Li Y, Wichmann HE, Stratmann B, Strauch K, Metspalu A, Gieger C, Suhre K, Adamski J, Illig T, Rathmann W, Roden M, Peters A, van Duijn CM, Boomsma DI, Meitinger T, Wang-Sattler R. Effects of metformin on metabolite profiles and LDL cholesterol in patients with type 2 diabetes. Diabetes Care. 2015 Oct;38(10):1858-67. doi: 10.2337/dc15-0658. Epub 2015 Aug 5.