Type 2 Diabetes Mellitus
Conditions
Interventions
test group:investigational product+NovoMix30
control group:placebo+NovoMix30
Sponsors
Tianjin Medical University Chu Hsien-I Memorial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years when signing written informed consent, regardless of gender; 2. BMI 18.5-30 kg/m2 ; 3. The patients diagnose diabetes according to the 1999 WHO diagnostic criteria for type 2 diabetes mellitus; 4. Patients who used NovoMix30 at least 3 months before taking the study drug(20 IU/d > insulin dosage > 1 IU/kg/d)and poor blood glucose control; 5. 7.5% <= HbA1c <= 9.5%; 6. Male subjects shall take effective contraceptive measures within 3 months from the signing of informed consent to the last medication, and shall not donate sperm during this period; Women of childbearing age must have negative serum pregnancy test results at the time of screening and must agree to use effective contraceptive measures from the time of signing the informed consent until 3 months after the last medication; 7. Good compliance, willing and able to follow the treatment and visit prescribed in the study protocol; 8. Able to understand the procedures and methods of this study, willing to strictly abide by the clinical trial protocol, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergies or intolerances to a-glycosidase inhibitor drugs; 2. Glucolipid metabolism affected by other factors, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, lesion of hypothalamus and pituitary, long-term glucocorticoids therapy in the past 6 months, requiring hospitalization; 3. Serious hypoglycemia with unknown inducement occurred in recent 6 months (need others to help recover); Or frequent hypoglycemia: for example, more than 2 hypoglycemic events (blood glucose 3 x ULN, or TBil > 2 x ULN); 5. Patients with impaired renal function (Cr 1.5 x ULN; 6. Patients diagnosed with gout; 7. Subjects have poor blood pressure control (SBP >= 160mmHg and/or DBP >= 100mmHg); 8. Have a history of drug abuse or alcohol dependence [drink more than 21 units (male) or 14 units (female) of alcohol per week (1 unit is about 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine); 9. Patients with chronic gastrointestinal disorders with obvious digestion and absorption disordersb; 10. Other endocrine diseases: such as hyperthyroidism, hypercortisolism, acromegaly, etc.; 11. History of heart failure (NYHA grade III or IV, Annex 6), or history of acute myocardial infarction or unstable angina pectoris within 6 months before screening; Or have a history of coronary angioplasty, coronary stent implantation or coronary artery bypass surgery within 6 months before screening, or have a recent cardiac surgery plan; Or QTc interval prolongation >= 500 ms; 12. Diseases that may cause hemolysis or erythrocyte instability and affect the detection of HbA1c, such as history of hemoglobinopathy (such as sickle cell anemia or thalassemia, sideroblastic anemia); 13. Patients with conditions that may worsen due to flatulence (such as Roemheld syndrome, severe hernia, intestinal obstruction, intestinal surgery and intestinal ulcers); 14. Have any type of malignant tumor (whether cured or not); 15. Patients who have participated in clinical trials of other drugs within one month; 16. 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); 17. Other conditions that the researchers think are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in Range; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Amplitude of Glycemic Excursion;mean blood glucose;Largest Amplitude of Glycemic Excursion;Area Under Curve 0-3h;Time above Range;Time below Range;HbA1c;fasting plasma glucose;2-hour postprandial blood glucose;blood fat;weight;Electrocardiograph; | — |
Countries
China
Contacts
Public ContactLiming Chen
Tianjin Medical University Chu Hsien-I Memorial Hospital
Outcome results
None listed