T2DM (Type 2 Diabetes Mellitus)DESTINYNCT03437109
Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus
An observational study of T2DM (Type 2 Diabetes Mellitus) and Hypogonadism, run by Besins Healthcare at 2 sites in Russia.
Trial summary
The purpose of the study is to get data of prevalence of testosterone deficiency in patient with T2DM in Russian Federation Read more about this study
- Who is it for?
- Ages 45 to 60 years, men only
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus), Hypogonadism
- What is being tested?
- Laboratory tests
- How many people
- 554 participants
- Where
- 2 sitesRussia
- Study dates
- 6 Dec 2017to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Men with T2DM aged between 45-60 years old
Who may be able to join
- Male 45-60 years old
- Diagnosis of T2DM according to approved standards
- Signed Informed Consent Form
Who cannot join
- 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;
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- Androgen therapy, administered at the time of the study or in the anamnesis;
- Admission of anabolic steroids;
- Alcoholism or drug addiction;
- Insolvency.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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
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)
- Conditions
- T2DM (Type 2 Diabetes Mellitus), Hypogonadism
- Being tested
- Laboratory tests
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory testsDiagnostic test
Testosterone HSBG Hb1Ac LH
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of hypogonadism in patients with T2DM
The prevalence of hypogonadism in patients with T2DM
Measured: 2017-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start6 Dec 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Besins Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marina SHESTAKOVA, academitian, Study chair, ENC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437109
- Sponsor's protocol ID
- BH-DM-11-2017
- Acronym
- DESTINY
- Status last verified
- Jan 2019
- First submitted
- 13 Feb 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Epidemiological Characteristics and Efficacy of Androgen Substitution for Hypogonadism in Men With Type 2 Diabetes Mellitus Under Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03437109
- Acronym / sponsor ID
- DESTINY / BH-DM-11-2017
- Conditions
- T2DM (Type 2 Diabetes Mellitus), Hypogonadism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Besins HealthcareIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to get data of prevalence of testosterone deficiency in patient with T2DM in Russian Federation
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Men with T2DM aged between 45-60 years old
Key inclusion criteria (3 listed)
- Male 45-60 years old
- Diagnosis of T2DM according to approved standards
- Signed Informed Consent Form
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory testsTestosterone HSBG Hb1Ac LH | Diagnostic test | – |
Primary outcome
The prevalence of hypogonadism in patients with T2DM
Time frame: 2017-2018
The prevalence of hypogonadism in patients with T2DM
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina SHESTAKOVA, academitian study chair
ENC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T2DM (Type 2 Diabetes Mellitus) and Hypogonadism, run by Besins Healthcare at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of hypogonadism in patients with T2DM (time frame: 2017-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.