Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female 18 -75 years of age; 2. Type 2 diabetes mellitus (diagnosed clinically) for >=3 years; 3. Current treatment: Insulin or insulin analogue dose >=40IU/day, and in any combination with less than two types oral hypoglycemic drugs, their dose are less than half of maximum dosage (metformin=25.0 kg/m2; 5. HbA1c 7.0-10.0%; 6. Serum C peptide>=1.5ug/L.
Exclusion criteria
Exclusion criteria: 1. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods; 2. Cardiovascular disease, defined as: stroke; decompensated heart failure New York Heart Association (NYHA)26 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; 3. Patients with serious gastrointestinal disease, for example: Peptic Ulcer, chronic diarrhea, pancreatitis; 4. Other endocrine disease, such as hyperthyroid disease, hypercortisolism; 5. Type 1 diabetes; 6. Proliferative retinopathy or maculopathy; 7. Impaired liver function, defined as ALAT or ASAT >=2.5 times upper limit of normal; 8. Impaired renal function defined as serum-creatinine >=125umol/L (>=1.4 mg/dL) for males and >=110umol/L (>=1.3 mg/dL) for females; 9. White blood cell < 3.5×10^9/Lblood platelet < 60×10^9/L, hemoglobin male <110g/L; female <100g/L; 10. Uncontrolled treated/untreated severe hypertension (systolic blood pressure 180 millimetre(mm) mercury (Hg) and/or diastolic blood pressure 100 mmHg); 11. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (MAO) inhibitors 12. Accepted the GLP-1 analogue or DDP4 inhibitor therapy; 13. Cancer and medical history of cancer; 14. Alcoholics or drug addict; 15. Suffer surgery or other stress; 16. Be allergic or with serious adverse Reaction to any of oral anti diabetic drugs; 17. Use of herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin;C peptide;FBG;PBG; | — |
Countries
China