Type 2 DiabetesPhase 4NCT03982238
Effects of Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients
A Phase 4 study testing Insulin, Metformin and Dapagliflozin in people with Type 2 Diabetes, run by Majianhua at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Insulin, Metformin and Dapagliflozin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2019to 31 Dec 2019
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to 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.
- HbA1c > 9%.
- subjects are able and willing to eat and exercise regularly.
Who cannot join
- patients with insulin allergy.
- impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.● drug abuse and alcohol dependence in the past 5 years.
- systemic hormone therapy was used in the last three months.
- patients with poor compliance and irregular diet and exercise.
- patients with infection and stress within 4 weeks.
- any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Continuous Subcutaneous Insulin Infusion and Oral Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Insulin, Metformin, Dapagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Continuous subcutaneous insulin infusion therapy for 1 month
MetforminDrug
Continuous subcutaneous insulin infusion plus metformin (at least1000mg/day) for 1 month
DapagliflozinDrug
Continuous subcutaneous insulin infusion plus metformin (10mg/day) for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | continuous subcutaneous insulin infusion therapy Receives: Drug: Insulin |
| Metformin | Experimental | metformin therapy Receives: Drug: Metformin |
| Dapagliflozin | Experimental | Dapagliflozin Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
total testosterone levels
changes of total testosterone levels
Measured: 1 month
Secondary outcomes (2)
bioavailable testosterone
changes of bioavailable testosterone
Measured: 1 month
free testosterone
changes of free testosterone
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start15 Jun 2019
- Primary completion15 Nov 2019
- Study completion31 Dec 2019
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 DiabetesStudies 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
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majianhua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Majianhua, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982238
- Sponsor's protocol ID
- KY20190530-12
- Status last verified
- Jun 2019
- First submitted
- 9 Jun 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hu Y, Ding B, Shen Y, Yan RN, Li FF, Sun R, Jing T, Lee KO, Ma JH. Rapid Changes in Serum Testosterone in Men With Newly Diagnosed Type 2 Diabetes With Intensive Insulin and Metformin. Diabetes Care. 2021 Apr;44(4):1059-1061. doi: 10.2337/dc20-1558. Epub 2021 Feb 3.
PubMed 33536253
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Subcutaneous Insulin Infusion and Oral Hypoglycemic Drugs on Testosterone Levels in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT03982238
- Acronym / sponsor ID
- KY20190530-12
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- MajianhuaUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jun 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Insulincontinuous subcutaneous insulin infusion therapy |
| Metformin | Experimental | Drug: Metforminmetformin therapy |
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- HbA1c > 9%.
- subjects are able and willing to eat and exercise regularly.
Key exclusion criteria (6 listed)
- patients with insulin allergy.
- impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.● drug abuse and alcohol dependence in the past 5 years.
- systemic hormone therapy was used in the last three months.
- patients with poor compliance and irregular diet and exercise.
- patients with infection and stress within 4 weeks.
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 |
|---|---|---|
| InsulinContinuous subcutaneous insulin infusion therapy for 1 month | Drug | Control group |
| MetforminContinuous subcutaneous insulin infusion plus metformin (at least1000mg/day) for 1 month | Drug | Metformin |
| DapagliflozinContinuous subcutaneous insulin infusion plus metformin (10mg/day) for 1 month | Drug | Dapagliflozin |
Primary outcome
total testosterone levels
Time frame: 1 month
changes of total testosterone levels
2 secondary outcomes
bioavailable testosterone
Time frame: 1 month
free testosterone
Time frame: 1 month
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 3 Apr 2020.
- Derived from this study: PubMed 33536253Hu Y, Ding B, Shen Y, Yan RN, Li FF, Sun R, Jing T, Lee KO, Ma JH. Rapid Changes in Serum Testosterone in Men With Newly Diagnosed Type 2 Diabetes With Intensive Insulin and Metformin. Diabetes Care. 2021 Apr;44(4):1059-1061. doi: 10.2337/dc20-1558. Epub 2021 Feb 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Insulin, Metformin and Dapagliflozin in people with Type 2 Diabetes, run by Majianhua at 1 site in China.
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 4 inclusion and 6 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 3 Apr 2020. 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 China. 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.
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?
total testosterone levels (time frame: 1 month). 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 NCT03982238, 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 3 Apr 2020.