Diabetes Mellitus, Type 1Phase 4NCT02765347
The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM
A Phase 4 study testing Metformin and Insulin in people with Diabetes Mellitus, Type 1, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The investigators intends to carry out a randomized, cross-over, prospective study which will last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe the effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM based on insulin therapy by using 72h CGMS… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Metformin and Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jan 2018
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus;
- Age≥12 yr;
- Tanner sexual maturation rating 2-5;
- HbA1c levels: 7.5%-10%;
- MDI or CSII ≥6 months;
- Insulin dose ≥ 0.8U/kg before the enrollment，and the dosage is stable at least >1 month（dosage change<10%）.
Who cannot join
- Serious acute and chronic complications associated with diabetes;
- Repeated and serious hypoglycemia episodes repeatedly;
- Hepatic function damage (ALT≥2.5 times higher than the upper limit of the normal accepted range);
- Moderate to advanced renal impairment (calculated according to MDRD equation: eGFR<60ml/min/1.73m2);
- Clinically significant heart attacks: myocardial infarction, arrhythmia，II-III°AVB，unstable angina，decompensated HF（NYHA III~IV;
- Female patients who have a sex life and are not willing to use contraceptive methods;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM: A Randomized, Cross-over, Prospective Study
The investigators intends to carry out a randomized, cross-over, prospective study which will last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe the effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.
- Conditions
- Diabetes Mellitus, Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
For arm 1, accept MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g tid) for 24 weeks.
InsulinDrug
Also called CSII or MDI
For arm 2, just accept insulin for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Metformin and Insulin | Other | MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g bid or tid) for 24 weeks Receives: Drug: Metformin |
| Insulin | Other | Accept insulin for 24 weeks Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: half one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Xu, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Wen Xu, Principal investigator, Associated professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765347
- Sponsor's protocol ID
- 2016-T1DM
- Status last verified
- Oct 2017
- First submitted
- 14 Feb 2016
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Metformin on Glycemic Control and Insulin Sensitivity in Adolescents With T1DM: A Randomized, Cross-over, Prospective Study
- ClinicalTrials.gov ID
- NCT02765347
- Acronym / sponsor ID
- 2016-T1DM
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 May 2016 (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.
The investigators intends to carry out a randomized, cross-over, prospective study which will last 48 weeks in youth with T1DM followed up by the center. The purpose is to observe the effects of metformin on glycemic control and insulin sensitivity in adolescents with T1DM based on insulin therapy by using 72h CGMS and hyperinsulinemic euglycemic clamps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin and Insulin | Other | Drug: MetforminMDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g bid or tid) for 24 weeks |
| Insulin | Other | Drug: InsulinAccept insulin for 24 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Type 1 diabetes mellitus;
- Age≥12 yr;
- Tanner sexual maturation rating 2-5;
- HbA1c levels: 7.5%-10%;
- MDI or CSII ≥6 months;
Key exclusion criteria (7 listed)
- Serious acute and chronic complications associated with diabetes;
- Repeated and serious hypoglycemia episodes repeatedly;
- Hepatic function damage (ALT≥2.5 times higher than the upper limit of the normal accepted range);
- Moderate to advanced renal impairment (calculated according to MDRD equation: eGFR<60ml/min/1.73m2);
- Clinically significant heart attacks: myocardial infarction, arrhythmia，II-III°AVB，unstable angina，decompensated HF（NYHA III~IV;
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 |
|---|---|---|
| MetforminAlso: GlucophageFor arm 1, accept MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g tid) for 24 weeks. | Drug | Metformin and Insulin |
| InsulinAlso: CSII or MDIFor arm 2, just accept insulin for 24 weeks | Drug | Insulin |
Primary outcome
HbA1c
Time frame: half one year
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 12 Apr 2018.
- 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.
Wen Xu principal investigator
Associated professor
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 Metformin and Insulin in people with Diabetes Mellitus, Type 1, run by Third Affiliated Hospital, Sun Yat-Sen University 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 6 inclusion and 7 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 12 Apr 2018. 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?
HbA1c (time frame: half one year). 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 12 Apr 2018.