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

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

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.

It had three arms (groups): Control group (active comparator), Metformin (experimental) and Dapagliflozin (experimental).

Continuous subcutaneous insulin infusion therapy.

Metformin therapy.

Dapagliflozin.

The registry classes the interventions as drug.

Who Took Part

74 actual participants took part.

It was open to men only aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Subjects are able and willing to eat and exercise regularly.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: patients with insulin allergy; systemic hormone therapy was used in the last three months; patients with poor compliance and irregular diet and exercise.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2019-06-15 with completion listed for 2019-11-15.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: total testosterone levels (time frame: 1 month).

It also tracked 2 secondary outcomes, for example bioavailable testosterone and free testosterone.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 74 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.