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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-15

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

continuous subcutaneous insulin infusion therapy

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Continuous subcutaneous insulin infusion therapy for 1 month

Metformin

metformin therapy

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Continuous subcutaneous insulin infusion plus metformin (at least1000mg/day) for 1 month

Dapagliflozin

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Continuous subcutaneous insulin infusion plus metformin (10mg/day) for 1 month

Interventions

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Insulin

Continuous subcutaneous insulin infusion therapy for 1 month

Intervention Type DRUG

Metformin

Continuous subcutaneous insulin infusion plus metformin (at least1000mg/day) for 1 month

Intervention Type DRUG

Dapagliflozin

Continuous subcutaneous insulin infusion plus metformin (10mg/day) for 1 month

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No