Type 1 Diabetes MellitusPhase 4NCT03513874
Metformin Plus Insulin on Non-obese Autoimmune Diabetes
A Phase 4 study testing Metformin and Insulin in people with Type 1 Diabetes Mellitus and Autoimmune Diabetes, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Autoimmune Diabetes
- What is being tested?
- Metformin and Insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Apr 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes according to ADA criterias <5 years.
- Age≥ 18 years and less than 70 years.
- Non-obese: defined as BMI less than 28 kg/m2
- Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
- Fasting or postprandial plasma C-peptide more than 100 pmol/L
- Written informed consent from the patient or family representative.
Who cannot join
- History of any malignancy or other severe diseases
- Female patients who are pregnant or breastfeeding before or during the three-year follow-up
- Poor compliance or refusal to participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Zhiguang Zhou, MD/PhD, 86-731-85292154, zhouzg@hotmail.com
About this study
Official title: The Effect of Metformin as add-on to Insulin in Non-obese Patients With Autoimmune Diabetes
The objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.
- Conditions
- Type 1 Diabetes Mellitus, Autoimmune Diabetes
- 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
Patients will be subscribed with 850mg metformin orally twice daily. Insulin will be continued as routine therapy.
InsulinDrug
Patients will continue insulin therapy following physicians' instructions.
| Study group | Role | What they receive |
|---|---|---|
| Metformin + Insulin | Experimental | Not described Receives: Drug: Metformin; Drug: Insulin |
| Insulin alone | Active comparator | Not described Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean amplitude of glycemic excursions (MAGE)
MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this 6-month study.
Measured: 6 months
Change in C-peptide
C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study.
Measured: 6 months
Secondary outcomes (5)
Change in HbA1c
Measured: 6 months
Change in daily insulin dose
Measured: 6 months
Change in body mass index (BMI)
Measured: 6 months
Change in lipid profiles
Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol
Measured: 6 months
Adverse effects
Adverse effects are recorded at each time-point of the follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Aug 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguang Zhou, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513874
- Sponsor's protocol ID
- MET201801
- Status last verified
- Mar 2020
- First submitted
- 12 Apr 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Metformin as add-on to Insulin in Non-obese Patients With Autoimmune Diabetes
- ClinicalTrials.gov ID
- NCT03513874
- Acronym / sponsor ID
- MET201801
- Conditions
- Type 1 Diabetes Mellitus, Autoimmune Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 2 May 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 objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin + Insulin | Experimental | Drug: Metformin, Drug: Insulin |
| Insulin alone | Active comparator | Drug: Insulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 1 diabetes according to ADA criterias <5 years.
- Age≥ 18 years and less than 70 years.
- Non-obese: defined as BMI less than 28 kg/m2
- Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
- Fasting or postprandial plasma C-peptide more than 100 pmol/L
Key exclusion criteria (3 listed)
- History of any malignancy or other severe diseases
- Female patients who are pregnant or breastfeeding before or during the three-year follow-up
- Poor compliance or refusal to participate.
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 |
|---|---|---|
| MetforminPatients will be subscribed with 850mg metformin orally twice daily. Insulin will be continued as routine therapy. | Drug | Metformin + Insulin |
| InsulinPatients will continue insulin therapy following physicians' instructions. | Drug | Insulin alone, Metformin + Insulin |
Primary outcome
Mean amplitude of glycemic excursions (MAGE)
Time frame: 6 months
MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this 6-month study.
Change in C-peptide
Time frame: 6 months
C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study.
5 secondary outcomes
Change in HbA1c
Time frame: 6 months
Change in daily insulin dose
Time frame: 6 months
Change in body mass index (BMI)
Time frame: 6 months
Change in lipid profiles
Time frame: 6 months
Adverse effects
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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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.
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 Type 1 Diabetes Mellitus and Autoimmune Diabetes, run by Second Xiangya Hospital of Central South 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 3 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: status not confirmed, as of the sponsor's last update on 18 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiguang Zhou, M.D./Ph.D (86-0731-85292154, zhouzg@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean amplitude of glycemic excursions (MAGE) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 18 Mar 2020.