Type 2 diabetes
Conditions
Interventions
Observation group:None
Sponsors
Beijing Chaoyang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Diagnosed with type 2 diabetes according to the diagnostic criteria of the WHO, and 7.0%=24 kg/m^2 3: Voluntarily participate in this study and sign the informed consent form 4: Those who meet either of the following two criteria at the time of screening: ? Those who have been stably using oral hypoglycemic drugs (except SGLT2i) for 8 weeks and have poor blood sugar control; ? Those who have stopped using other non-constant pagliflozin SGLT2i for more than 4 weeks and have poor blood sugar control.
Exclusion criteria
Exclusion criteria: 1: Those who are allergic to the test drug or any of its components 2: Participated in the clinical trials of other diabetes treatment drugs within one month before the start of this study 3: Currently, systemic steroid hormones are being used for treatment 4: Those who have experienced acute metabolic complications within 6 months (such as ketoacidosis, lactic acidosis or hyperosmolar coma, etc.) 5: Those who have experienced negligent compensatory heart failure (NYHA grade IV), unstable angina pectoris, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or have undergone cardiac surgery or vascular reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) within 6 months 6: Those with malignant tumors and an expected lifespan of less than one year, active tuberculosis patients, and acute infections 7: Those with a history of current or previous recurrent urinary tract infections or/and genital infections 8: For patients with a history of hypertension whose blood pressure has not been effectively controlled after antihypertensive drug treatment: Systolic blood pressure (SBP) 180 mmHg and/or diastolic blood pressure (DBP) 110 mmHg 9: Renal function indicators met the following criteria: eGFR < 30 ml/min/1.73 m^2 (calculated based on the Chronic Kidney Disease Epidemiology Collaboration [CKD - EPI] formula) 10: Fertile men or women who are unwilling to use contraception during the trial, pregnant or lactating women 11: In addition to the above, patients determined by the researchers as unsuitable to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of HbA1c from the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of fasting blood glucose from baseline;The change of 2-hour postprandial blood glucose compared with the baseline;Changes in fasting insulin levels compared with the baseline;The change in body weight compared to the baseline;The proportion of patients with a weight loss of >=5%;The change in waist circumference compared to the baseline;The change in BMI compared to the baseline;Composite endpoint: The proportion of patients with a >=1% decrease in HbA1c from baseline and a >=3% decrease in body weight;The other metabolic parameters from baseline; | — |
Countries
China
Contacts
Public ContactWang Guang
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed