Patients with type 2 diabetes mellitus complicated with erectile dysfunction
Conditions
Interventions
Experimental group:Metformin + Xiaoke Pill
Control group:Metformin + Sitagliptin
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Meet the diagnostic criteria for type 2 diabetes, with disease duration >1 year; 3. Male patients; 4. Age >40 years, =1500 mg/day or the maximum tolerated dose: although 1000 mg/day) for at least 8 weeks; 7. HbA1c between 7.0% and 9.5%; 8. International Index of Erectile Function (IIEF-5) score <21, and no systemic treatment for erectile dysfunction in the past 3 months; 9. SCL-90 scale: (1) Anxiety <2, Depression <2; (2) Erectile difficulty related to mood/stress <1; 10. Penile color Doppler ultrasound: peak systolic velocity (PSV) <30 cm/s.
Exclusion criteria
Exclusion criteria: 1. Severe cardiac dysfunction (New York Heart Association Class V), severe liver dysfunction (ALT or AST more than 2.5 times the upper limit of normal), severe renal dysfunction [GFR < 45 mL/(min•m^2)]; 2. Severe psychiatric disorders, organic urogenital diseases, diffuse toxic goiter, type 1 diabetes, type 2 diabetes with ketoacidosis, various infections, surgery, trauma, or other stressful conditions; 3. Use of antidiabetic medications other than metformin within 8 weeks prior to randomization (including traditional Chinese medicine); 4. History of more than 2 grade 3 hypoglycemic episodes within 1 year prior to randomization; 5. Occurrence of diabetic ketoacidosis or hyperglycemic hyperosmolar state within 3 months prior to randomization; 6. Untreated or poorly controlled hypertension at the time of screening/randomization; 7. Participation in other drug clinical trials within the past 3 months or patients deemed by the investigator unable to comply with regular follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Glucose Fluctuation Index;Time in Range (TIR) of blood glucose in week 12;Time Above Range,TAR;Time Below Range,TBR;Average glucose variability changed from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline at Week 12;Changes in FPG, body weight, and blood pressure at weeks 4, 8, and 12 compared to baseline;Quality of life and erectile function: Changes from baseline in DQOL, IIEF-5, EHS, and SCL-90 scores at week 12;Penile color Doppler examination: changes in peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI) at week 12 compared with baseline;Testosterone and Free Testosterone: Changes from Baseline at Week 12;Flow-Mediated Dilation (FMD): Change from baseline at week 12; | — |
Countries
China
Contacts
Public ContactCao Ying
Southern Medical University Southern Hospital
Outcome results
None listed