diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: This study included type 2 diabetes patients with poorly controlled glucose treated with premixed insulin therapy. The inclusive criteria listed as follows 1. Type 2 diabetes; 2. treated with premixed insulin therapy = 3 months, and the current insulin dose = 20 IU/d, <1 IU/kg·d as well; 3. aged 30 - 70 years old; 4. BMI within the range of 18.535.0 kg/m2; 5. HbA1c 7.0% to 10.0%; 6. patients who have signed informed consent; 7. patients with the ability to conduct self-blood glucose monitoring.
Exclusion criteria
Exclusion criteria: exclusion criteria are as follows: 1. women with fertility, pregnancy, breastfeeding, willingness to pregnant during the study period, or not using appropriate contraceptive measures; 2. type 1 daibetes, GDM, or other special types of diabetes; 3. with gastrointestinal diseases, or can't tolerate a-glucosidase inhibors; 4. allergic to acarbose, metformin or related agents (known or suspected); 5. severe liver disease (ALT/AST > 1.5 times of the normal upper limit); 6. with unstable or severe angina, heart failure (NYHA III/IV); 7. with chronic wasting disease (malignant tumors, tuberculosis, etc.), blood disease, mental disease, autoimmune diseases, obvious digestion and absorption disorders, suffer from acute cerebrovascular disease in the latest 6 months; 8. drinking/smoking history; 9. can't control/untreated hypertension (defined as SBP = 180 mmHg and/or DBP = 100 mmHg); 10. treat with drugs which affect glucose metabolism, such as glucocorticoids, thyoxine; 11. renal dysfunction, defined as serum creatinine = 135 µmol/L (= 1.5 mg/dl, male) and = 110 µmol/L (= 1.3 mg/dl, female); 12. any metformin contraindications; 13. without the bility to conduct self-monitoring of blood glucose; 14. under the therapy of premixed insulin, combined with = 2 oral hypoglycemic agents, or with one oral hypoglycemic drug which reached the maximum therapeutic dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amplitude of Plasma Glucose Excursions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diurnal fluctuation of blood glucose;glycated hemoglobin A1c;1,5-anhydroglucitol;fasting plasma glucose;2h postprandial glucose;body weight;insulin; | — |
Countries
China
Contacts
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital