Type 2 diabetes mellitus with overweight or obese
Conditions
Interventions
Experimental group:Orlistat 0.12g (1 capsule) with meals or within one hour after meals, 3 times a day for 12 weeks
Control group:Placebo
Sponsors
Shanghai Tongren Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Obtain the subject's informed consent; 2. Male and female aged 18-65 years at the time of screening; 3. Meet the diagnostic criteria of diabetes refer to the diagnostic criteria of WHO in 1999, that is, plasma glucose >= 11.1 mmol/L after 2 hours of meal and/or fasting plasma glucose >= 7.0 mmol/L. The clinical features were consistent with type 2 diabetes, and fasting insulin and C peptide were close to the normal level; 4. Body mass index meets the following requirements: BMI >= 24.0 kg/m^2; 5. 6.0% = 3 months, and the weight change in recent 3 months is ± 1.0 kg; 7. Female subjects had no family planning during the trial and took corresponding contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Abnormal liver function with ALT and AST more than 2.5 times the upper limit of normal; 2. Patients who used sglt-2 inhibitors within 3 months before enrollment; 3. Renal impairment, serum creatinine: female >= 124 umol/L (>= 1.40 mg/dl), male >= 133 umol/L (>= 1.50 mg/dl), eGFR 1800 mg/g; 13. According to the judgment of the researcher, major hypoglycemic events or unintentional hypoglycemia occurred repeatedly before screening; 14. There were more than two ketoacidosis events or episodes of hyperosmolar hyperglycemia requiring hospitalization within 6 months before screening; 15. Patients receiving thyroid hormone replacement therapy in recent 3 months; 16. Patients considered unsuitable by the investigator to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight change; | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist circumference;Body fat rate;Low density lipoprotein;Triglyceride;Fasting blood glucose;Postprandial 2-hour blood glucose;Glycosylated hemoglobin;Fasting insulin;Insulin resistance index (HOMA-IR);Side effects; | — |
Countries
China
Contacts
Public ContactHuang Shan
Shanghai Tongren Hospital
Outcome results
None listed