Effects of Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients

Majianhua

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Dapagliflozin; Drug: Metformin; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03982238

KY20190530-12

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

74 participants in 3 patient groups

Control group

Active Comparator group

Description:

continuous subcutaneous insulin infusion therapy

Treatment:

Drug: Insulin

Metformin

Experimental group

Description:

metformin therapy

Treatment:

Drug: Metformin

Dapagliflozin

Experimental group

Description:

Dapagliflozin

Treatment:

Drug: Dapagliflozin