diabetes mellitus
Conditions
Interventions
A:metformin 500mg qd (8a)
B:Metformin 500mg bid (8a, 5p)
C:Metformin 500mg tid (8a, 12n, 5p)
D:Metformin 500mg (8a), 1000mg (12n), 500mg (5p)
E:Metformin 500mg (8a) 1000mg (12n), 1000mg (5p)
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patients who 1. sign the consent form; 2. diagnosed as T2DM based on the diagnostic standards issued by WHO in 1999; 3. male or female, aged from 18-75 years old; 4. Pregnant possibility of women must be minimized in the study, from the beginning to the 28th day after the end of the study to avoid pregnancy with appropriate contraception; 5. Hemoglobin A1C limited from 6.5-9.0%, and fasting blood-glucose >7.0mmol/L or(and) postprandial blood glucose >11.1mmol/L.
Exclusion criteria
Exclusion criteria: The patients who 1. are in pregnancy or lactation; 2. have got the gastrointestinal surgery may having effect on the absorption of metformin; 3. have the medical history of hemoglobinopathy, acute progressive nephropathy or autoimmunity dermatosis; 4. have history of drug or alcohol abuse in past 1 year; 5. have contraindications listed on the direction; 6. have history of or are suffering from acute or chronic pancreatitis; 7. have history of type 1 diabetes, diabetic ketoacidosis or hyperosmolar nonketotic coma; 8. are diagnosed as congestive heart failure in level of III or IV and/or left ventricular ejection fraction 2*ULN, ALT>2*ULN, and/or total bilirubin >34umol/L or have history of infectious hepatitis; 10. have obvious signs or symptoms of hepatopathy, acute active hepatitis or chronic active hepatitis; 11. have any cliniclly significant abnormal results in laboratory examination or electrocardiogram, which may imperil these lives or affect the clinical trial based on the judgment of researchers; 12. fasting plasma glucose(FPG) >13.3mmol/l; 13. are nephropathy patients and endogenous creatinine clearance rate (CCr)<=90ml/min.; 14. patients have been reported as being secondary to severe hyperglycemia and have to use another drugs to control the level of blood glucose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin;Total DNA of intestinal flora; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma-glucose;Postprandial blood glucose;Intestinal inflammatory factor; | — |
Countries
China
Contacts
Public ContactDong Jianjun
Outcome results
None listed