Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed patients with type 2 diabetes; 2.Aged between 18 and 75 years at the time of signing the informed consent form; 3.Body Mass Index (BMI): 18.5-40 kg/m^2; 4.Hemoglobin A1c (HbA1c) levels >= 7% and <= 9.5%; 5.Willing to provide written informed consent and to comply with the study protocol;
Exclusion criteria
Exclusion criteria: 1) Treatment with any antidiabetic medication within 3 months prior to screening; 2) patients with high blood glucose requiring insulin intensification (HbA1c > = 9%, fasting blood glucose > = 11.1 mmol/L); 3) History of severe hypoglycemia without contributing factors (requiring external assistance to recover) or history of recurrent hypoglycemia (such as 3 or more episodes of hypoglycemia 2.5×Upper limit of normal (ULN), or aspartate aminotransferase (AST) >2.5×ULN or serum total bilirubin (TBiL) >1.5×ULN; 9) Unstable or rapidly progressing renal disease; 10) Diagnosed with mental illness; 11) Malignancy of any type (whether cured or not) 12) Treatment with systemic steroids for more than 2 weeks in the last three months, or change within 6 weeks prior to informed consent Thyroid hormone dose or any other uncontrolled endocrine disease other than T2DM; 13) No other clinical trials have been participated in 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Countries
China
Contacts
Shanghai Sixth People’s Hospital