ClinicalTrials.gg
CompletedNCT03437109DESTINYUpdated Jun 20, 2019

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

An observational study in T2DM (Type 2 Diabetes Mellitus) and Hypogonadism, sponsored by Besins Healthcare. Completed at 2 sites in Russian Federation. Open to male participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-06-20.

Sponsored by Besins Healthcare · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
554
Ages
45 Years to 60 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 277 studies in Diabetes Mellitus, Type 2 with a site in Russian Federation — none open to participants now, none under way, none of them phase 3. Diabetes Mellitus, Type 2 · Russian Federation.

Enrollment
21st of 24
554 · median 2,743
Started
2017
with 18 others
Observational
24 of 277
none open now
Registered
247th of 277
by date

Among the 277 studies in Diabetes Mellitus, Type 2 with a site in Russian Federation, this one is the 21st largest by enrollment of the 24 observational ones that give a count, is one of 19 that started in 2017, is one of 24 observational ones, and was the 247th registered.

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

None of the 277 studies in Diabetes Mellitus, Type 2 with a site in Russian Federation is open now. The open studies under Diabetes Mellitus, Type 2, anywhere →

Who these studies take

Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 45 Years to 60 Years · male · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 277 studies in Diabetes Mellitus, Type 2 with a site in Russian Federation as a file.
02

Study summary

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

Read the 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)

03

Conditions studied

  • T2DM (Type 2 Diabetes Mellitus)
  • Hypogonadism
04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Men with T2DM aged between 45-60 years old

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
554 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testLaboratory tests

    Testosterone HSBG Hb1Ac LH

06

What researchers measure

Primary outcomes

  1. The prevalence of hypogonadism in patients with T2DM

    The prevalence of hypogonadism in patients with T2DM

    Time frame: 2017-2018

07

Study locations

2 sites
  • ENC
    Moscow, 117036, Russian Federation
  • Central Clinical Hospital
    Moscow, 121359, Russian Federation
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Feb 2019, 13 months.

Of 170 industry-sponsored observational studies under Diabetes Mellitus, Type 2, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's 13 months is below that.

Counting every sponsor, half of 602 studies reached it within 32 months; a quarter within 17 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Feb 19, 2018
StartActual
Dec 6, 2017
Primary completionActual
Feb 1, 2019
CompletionActual
Feb 1, 2019
Last update
Jun 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03437109
Lead sponsor
Besins Healthcare
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Dec 6, 2017
Primary completion
Feb 1, 2019
Completion
Feb 1, 2019
Last update
Jun 20, 2019

Study contacts

Marina SHESTAKOVA, academitian
study chair · ENC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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