Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus (DESTINY)

June 19, 2019 updated by: Besins Healthcare

Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice

The purpose of the study is to get data of prevalence of testosterone deficiency in patient with T2DM in Russian Federation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice (DESTINY)

Study Type

Observational

Enrollment (Actual)

554

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117036
        • ENC
      • Moscow, Russian Federation, 121359
        • Central Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Men with T2DM aged between 45-60 years old

Description

Inclusion Criteria:

  • Male 45-60 years old
  • Diagnosis of T2DM according to approved standards
  • Signed Informed Consent Form

Exclusion Criteria:

  • Prepubertal hypogonadism of any genesis;
  • Sexual and developmental disorders;
  • Absence of at least one of the testicles;
  • Cryptorchidism, including in the anamnesis;
  • Injuries and / or surgical interventions on the genitals with loss of at least one of the testicles;
  • Established diagnosis of panhypopituitarism in accordance with current recommendations / standards;
  • Androgen therapy, administered at the time of the study or in the anamnesis;
  • Admission of anabolic steroids;
  • Alcoholism or drug addiction;
  • Insolvency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of hypogonadism in patients with T2DM
Time Frame: 2017-2018
The prevalence of hypogonadism in patients with T2DM
2017-2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Besins Healthcare

Investigators

  • Study Chair: Marina SHESTAKOVA, academitian, ENC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2017

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

February 13, 2018

First Submitted That Met QC Criteria

February 16, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 19, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH-DM-11-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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