Type 2 Diabetes MellitusPhase 4NCT01560546
Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
A Phase 4 study testing Testosterone in people with Type 2 Diabetes Mellitus and Hypogonadism, run by Marianne Andersen at 1 site in Denmark.
Trial summary
A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM. Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypogonadism
- What is being tested?
- Testosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Nov 2013
- Phase
- Phase 4
- 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 50 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male gender age 50-70
- Bioavailable testosterone < 7,3 nmol/L
- Metformin treatment of T2DM for 3 months or more
Who cannot join
- HbA1c > 9,0 %, BMI > 40 kg/m2, Haematocrit > 50%,
- Known malignant disease, PSA > 3 ug/L, Nycturia > 3 times,
- Abnormal routine blood samples,
- Severe hypertension,
- Significant EKG-changes,
- Wish of parenthood,
Show all 10Show fewer
- Active mental illness,
- former or present abuse,
- Severe illness of heart-, lung- or kidney,
- Primary or secondary hypogonadism.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Odense University Hospital
Odense, 5000
About this study
Official title: Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.
A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.
Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance.
Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.
Read the detailed description
Background Inadequate levels of androgens have been associated with an increased risk of chronic illnesses including obesity and diabetes. Moreover, testosterone treatment has been shown to increase lean body mass and lipid oxidation as well as insulin sensitivity in hypogonadal men.
- Conditions
- Type 2 Diabetes Mellitus, Hypogonadism
- Being tested
- Testosterone, Placebo
- 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.
TestosteroneDrug
Also called Testim
50 mg/dose/day for 24 weeks
PlaceboDrug
placebo on the skin for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Testim | Active comparator | Not described Receives: Drug: Testosterone |
| Placebo | Placebo comparator | Placebo for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass
Accessed by DXA scanning
Measured: approximately three years
Secondary outcomes (8)
Insulin sensitivity
Euglycemic hyperinsulinaemic clamp
Measured: three years
Regional body composition and liver fat
DXA- and MR-scans and spect
Measured: three years
Glucose and lipid oxidation
Indirect calorimetry
Measured: three years
Myostatin and satellite cells
Muscle biopsy
Measured: 8 years
Inflammation
Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.
Measured: 8 years
Physical activity
Questionaires
Measured: three years
Quality of life
Questionaires
Measured: three years
Sexual function
Questionaires
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marianne Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor-investigator, Marianne Andersen, Odense University Hospital
- Investigators
- Marianne Andersen, MD, ph.d., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560546
- Sponsor's protocol ID
- 2011-002102-73
- Status last verified
- Nov 2013
- First submitted
- 20 Mar 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Botha J, Velling Magnussen L, Nielsen MH, Nielsen TB, Hojlund K, Andersen MS, Handberg A. Microvesicles Correlated with Components of Metabolic Syndrome in Men with Type 2 Diabetes Mellitus and Lowered Testosterone Levels But Were Unaltered by Testosterone Therapy. J Diabetes Res. 2017;2017:4257875. doi: 10.1155/2017/4257875. Epub 2017 Jan 12.
PubMed 28168203
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.
- ClinicalTrials.gov ID
- NCT01560546
- Acronym / sponsor ID
- 2011-002102-73
- Conditions
- Type 2 Diabetes Mellitus, Hypogonadism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Marianne AndersenUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Mar 2012 (estimated)
- 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.
A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM.
Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance.
Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.
Detailed description
Background Inadequate levels of androgens have been associated with an increased risk of chronic illnesses including obesity and diabetes. Moreover, testosterone treatment has been shown to increase lean body mass and lipid oxidation as well as insulin sensitivity in hypogonadal men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testim | Active comparator | Drug: Testosterone |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 24 weeks |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male gender age 50-70
- Bioavailable testosterone < 7,3 nmol/L
- Metformin treatment of T2DM for 3 months or more
Key exclusion criteria (10 listed)
- HbA1c > 9,0 %, BMI > 40 kg/m2, Haematocrit > 50%,
- Known malignant disease, PSA > 3 ug/L, Nycturia > 3 times,
- Abnormal routine blood samples,
- Severe hypertension,
- Significant EKG-changes,
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 |
|---|---|---|
| TestosteroneAlso: Testim50 mg/dose/day for 24 weeks | Drug | Testim |
| Placeboplacebo on the skin for 24 weeks | Drug | Placebo |
Primary outcome
Lean body mass
Time frame: approximately three years
Accessed by DXA scanning
8 secondary outcomes
Insulin sensitivity
Time frame: three years
Regional body composition and liver fat
Time frame: three years
Glucose and lipid oxidation
Time frame: three years
Myostatin and satellite cells
Time frame: 8 years
Inflammation
Time frame: 8 years
Physical activity
Time frame: three years
Quality of life
Time frame: three years
Sexual function
Time frame: Three years
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 14 Nov 2013.
- Derived from this study: PubMed 28168203Botha J, Velling Magnussen L, Nielsen MH, Nielsen TB, Hojlund K, Andersen MS, Handberg A. Microvesicles Correlated with Components of Metabolic Syndrome in Men with Type 2 Diabetes Mellitus and Lowered Testosterone Levels But Were Unaltered by Testosterone Therapy. J Diabetes Res. 2017;2017:4257875. doi: 10.1155/2017/4257875. Epub 2017 Jan 12.
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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.
Marianne Andersen, MD, ph.d. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone in people with Type 2 Diabetes Mellitus and Hypogonadism, run by Marianne Andersen at 1 site in Denmark.
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 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lean body mass (time frame: approximately three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01560546, which also lists 1 linked publication.
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 14 Nov 2013.