type 2 diabetes
Conditions
Interventions
Group A:Diamicron MR 30mg/d
Group B:Diamicron MR 60mg/d
Sponsors
Shanghai First People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Newly diagnosed patients with T2DM (WHO criteria, 1999) who are in need of oral medications; (2) Antiglutamic acid decarboxylase (GAD) antibody negative (-); (3) HbA1c between 7-11%; (4) Aged 18-75 years, either male or female; (5) BMI ranged 20-28kg/m2; (6) ALT/AST= 2.5×ULN, and serum creatinine = 1.1×ULN within 14 days before enrollment; (7) Patients who are willing and able to perform SMBG and keep a subject diary; (8) Patients who understand study purpose, procedures and content; are willing to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) T1DM or other special types of diabetes; (2) Patients who have been treated with antidiabetic agents; (3) Severe metabolic complications induced by diabetes, including ketoacidosis, neurological and mental dysfunction caused by severe metabolic disorders, proliferative retinopathy in need of operative treatment; (4) Experience of angina, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, or other severe cardiovascular and cerebrovascular events, or cardiac function III-IV in previous 6 months; (5) Digestive diseases significantly affecting absorptive function; (6) Use of other medications affecting blood glucose regulation, including corticosteroids, growth hormone, oral contraceptives and sex hormones, thiazide diuretics, clonidine, beta-adrenergic agonists, cyclosporin, phenytoin, etc.; (7) Use of miconazole; (8) Patients with abnormal hemoglobinopathy; (9) Patients diagnosed with malignant tumor in recent 5 years; (10) Patients with schizophrenia or other mental disorders influencing study evaluation; (11) Patients with alcohol dependence and/or substance abuse; (12) Allergy to study drug or its excipients; (13) Patients included in other research or treatment within 3 months prior to enrollment; (14) Pregnancy, nursing mothers, women close to the time of delivery, and those who are not willing to take effective measures of contraception; (15) Any other cases which are deemed as inappropriate to participate in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1; | — |
Secondary
| Measure | Time frame |
|---|---|
| FPG;PPG30/60/120;FINS;INS30/60/120;7-point glucose profil; | — |
Countries
China
Contacts
Public ContactYongde Peng
Shanghai First People's Hospital
Outcome results
None listed