T2DM
Conditions
Interventions
A Group:insulin aspart 30 (NovoMix30) and metformin (Glucophage) combination group
B Group:insulin aspart 30 (NovoMix30) monotherapy group
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: Main inclusion criteria: 1. Diagnosed as T2DM; 2. Treated with two or more OADs for more than three months and blood glucose has met HbA1c>=7% (the HbA1c result within 14 days before the screening day is effect); 3. Aged from 18 to 79 years old, regardless of gender; 4. BMI>=18.5kg/m2; 5. According to investigators' judgment, subjects are able and willing to obey the following perspectives: (1) During the whole study, treatment will be continued according to the requirements in the protocol; (2) During the whole study, diet will be maintained according to the requirements in the protocol (3) Participating in regular visits, and willing to receive telephone follow-up; (4) Female who has the possibility to bear (and male whose partner has the possibility to bear) is willing to receive effective contraceptions during the whole study; 6. Male or female who are not pregnant or breastfeeding; 7. Without metformin contraindications; 8. Signing informed consent form before any study relevant activities have been conducted.
Exclusion criteria
Exclusion criteria: Main exclusion criteria: 1. T1DM; 2. Previously treated with insulin for more than 14 days continuously within 3 months before screening visit or within one month before the patient entering the study; 3. Occurring any of the following cardiovascular diseases within three months before screening visit: acute myocardial infarction, heart function classification III/IV according to New York Heart Association, congestive heart failure with left ventricular ejection fraction =2.0 times of the upper limit of the reference range at the screening visit; 5. Serum creatinine >=1.5mg/dl (133 umol/L) for male, >=1.4mg/dl (124umol/L) for female or eGFR=180mmHg, or diastolic blood pressure >=105mmHg); 9. Severe chronic gastrointestinal diseases; 10. History of diabetic ketoacidosis or hypertonia condition/coma once or more than once; 11. Receiving long-term (>14 days) systemic glucocorticoid treatment (external use, intraocular, inhaled or intranasal preparations except) or received this type of treatment within four weeks before screening visit; During the whole study, any treatment which can affect glucose regulation should be avoided, as thyroid medication, estrogen, oral contraceptives, phenytoin, niacin, sympathomimetic drugs and isoniazid. 12. Hematological system diseases which maybe affect HbA1c value (as hemolytic anemia, sickle cell disease); 13. Any conditions which may affect patients follow and complete the study protocol (as known drug abuse, alcoholic, mental diseases); 14. Currently in a study or 30 days before recruiting withdrawing from a study which involves the investigational medicinal product or not approved drugs or instruments; or participating other types of clinical studies at the same time and not suitable to participate in this study judged by investigators from medical or science perspectives; 15. Allergic to metformin/insulin or with metformin/insulin contraindication; 16. Combined with severe lung diseases or history of hypoxia; 17. Combined with endocrine diseases as hypercortisolism; patients with thyroid diseases under control of drugs for more than half year can be included; 18. Stress state as surgery, acute craniocerebral injury etc; 19. Vitamin B12 deficiency without correction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| FPG;PPG;Blood Lipid Profile;insulin sensitivity index; | — |
Countries
China
Contacts
Public ContactLiXin Guo
Outcome results
None listed