type 2 diabetes
Conditions
Interventions
Group A:50mg chewable tablets/50mg tablets/50mg capsules
Group B:50mg capsules/50mg chewable tablets/50mg tablets
Group C:50mg tablets/50mg chewable tablets/50mg capsules
Sponsors
Jinan Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Diagnosed as type 2 diabetes (WHO standard, 1999), no gender limit. 2) Aged between 18 to 65 years old. 3) Patients who used a stable dose of metformin monotherapy for at least 4 weeks before taking the study drug, and the postprandial plamsa glucose (2h postprandial) was controlled >= 11.1 mmol/L; or did not receive any hypoglycemic treatment within three months, and postprandial plasma glucose (2h postprandial) was controlled >= 11.1 mmol/L; including threshold; 4) Body mass index (BMI):19kg/m^2 <= BMI <= 35kg/m^2; 5) Volunteer to participate in the trial and sign the informed consent; the process of obtaining the informed consent conforms to GCP.
Exclusion criteria
Exclusion criteria: 1) Allergies or intolerances to a-glycosidase inhibitor drugs; 2) Patients with severe diabetic complications; 3) Patients with hyperlipidemia who take lipid-lowering drugs or fasting triglycerides (TG)>3.5mmol/l; 4) Patients with chronic gastrointestinal disorders with obvious digestion and absorption disordersb, and other endocrine diseases: such as hyperthyroidism, hypercortisolism, acromegaly, etc.; 5) Patients with conditions that may worsen due to flatulence (such as Roemheld syndrome, severe hernia, intestinal obstruction, intestinal surgery and intestinal ulcers); 6) Myocardial infarction, acute onset of unstable angina, chronic heart insufficiency (NYHA class III and IV), malignant arrhythmia occurred within 6 months before screening; 7) Subjects (taking or not taking antihypertensive drugs) have poor blood pressure control (SBP >= 160mmHg and/or DBP >= 100mmHg); 8) Patients with liver disease (ALT or AST > 2 x ULN, or TBil > 2 x ULN); 9) Patients with impaired renal function (Ccr < 60ml/min); 10) Patients have used drugs that affect glucose metabolism, such as systemic glucocorticoids, within 6 months before screening; 11) Patients who have combined use of Chinese herbal medicines with the effect of regulating blood sugar within three months before screening; 12) Patients with serious diseases who may be dying during the treatment period and follow-up period in the case of a researcher's judgment; 13) Patients with mental or neurological disorders and unable to express their wishes correctly; 14) Alcoholics and drug abusers and addicts; 15) Women of childbearing age are pregnant, breastfeeding, have intention to become pregnant, or have a positive pregnancy test (testing urine HCG or blood HCG), and cannot use effective contraceptive measures during the test period (effective contraceptive measures include sterilization, intrauterine device, oral contraception Medicine or the diaphragm method stipulated by local law); 16) Patients who have participated in clinical trials of other drugs within one month; 17) Other conditions that the researchers think are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postprandial plasma glucose flucturation;Security; | — |
Countries
China
Contacts
Public ContactQing Wen
Outcome results
None listed