Type 2 Diabetes
Conditions
Brief summary
The study will assess the total testosterone and sex hormone-binding globulin levels in men with type 2 diabetes before and after continuous subcutaneous insulin infusion and hypoglycemic drugs treatment.
Interventions
DRUGInsulin
Continuous subcutaneous insulin infusion therapy for 1 month
DRUGMetformin
Continuous subcutaneous insulin infusion plus metformin (at least1000mg/day) for 1 month
DRUGDapagliflozin
Continuous subcutaneous insulin infusion plus metformin (10mg/day) for 1 month
Sponsors
Majianhua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* volunteer to participate and be able to sign informed consent prior to the trial. * patients with type 2 diabetes, aged 18-60 years old, meeting WHO1999 diagnostic criteria, have not used any hypoglycemic drugs. * HbA1c \> 9%. * subjects are able and willing to eat and exercise regularly.
Exclusion criteria
* patients with insulin allergy. * impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.● drug abuse and alcohol dependence in the past 5 years. * systemic hormone therapy was used in the last three months. * patients with poor compliance and irregular diet and exercise. * patients with infection and stress within 4 weeks. * any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total testosterone levels | 1 month | changes of total testosterone levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bioavailable testosterone | 1 month | changes of bioavailable testosterone |
| free testosterone | 1 month | changes of free testosterone |
Countries
China
Outcome results
None listed