Type 1 Diabetes MellitusPhase 4NCT03011008
Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus
A Phase 4 study testing Liraglutide 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 purpose of this study is to investigate the therapeutic effect of Liraglutide on autoimmune diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Autoimmune Diabetes
- What is being tested?
- Liraglutide and Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes according to ADA criteria <3 years.
- Age≥ 18 years.
- 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 or family history of medullary thyroid carcinoma or MEN 2 syndrome;
- History of chronic or acute pancreatitis;
- Allergic to liraglutide or any components in Victoza®;
- Hepatic abnormalities (transaminase > 2 times normal);
- Renal impairments (serum creatinine >133 umol/L);
- Cardiovascular diseases (hypertension, coronary heart disease, etc.);
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- Presence of acute metabolic disorders; In the case of acute ketone acidosis, with blood ketone over 0.3mmol/L and pH lower than 7.30;
- Any history of malignancy;
- Female patients who are pregnant or breastfeeding; any female who is unwilling to use a reliable and effective form of contraception for 2 years after recruitment;
- Presence of any infectious diseases, including active skin infections, flu, fever, upper or lower respiratory tract infections; those who wish to participate in the study should keep the infection under control for at least 1 week before receiving Treg product infusion;
- Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
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: Effect of Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus
The purpose of this study is to investigate the therapeutic effect of Liraglutide on autoimmune diabetes.
Read the detailed description
Autoimmune Diabetes Mellitus (AIDM) is a subtype of diabetes mellitus caused by autoimmune destruction of beta cells in the islet, including Type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA). Insulin has been used as a routine therapy for AIDM to alleviate the hyperglycemic status, yet cannot effectively prevent the progressing destruction of beta cells or preserve its function. Glucagon-like peptide (GLP-1) analog Liraglutide has been tested in large-scale clinical trial to prove its various benefits for beta cells and glucolipid metabolism in Type 2 diabetes and obesity patients. However, its clinical application in AIDM is not well-defined so far. The aim of this study is to investigate the potential use of Liraglutide on glycemic control in AIDM.
- Conditions
- Type 1 Diabetes Mellitus, Autoimmune Diabetes
- Being tested
- Liraglutide, Insulin
- 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.
LiraglutideDrug
Dose escalation of liraglutide starts from 0.6 mg up to 1.2 mg per day.
InsulinDrug
Receive insulin following clinician's instruction.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide + insulin | Experimental | Patients will be subjected to a dose escalation of liraglutide up to 1.2 mg, then continue to receive the reached liraglutide dose once daily for 6 months thereafter. Insulin will be continued as routine therapy. Receives: Drug: Liraglutide; Drug: Insulin |
| Insulin | Active comparator | Patients will receive insulin injection as a routine therapy. 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 one-year study.
Measured: 1 year
Secondary outcomes (5)
Change in HbA1C
Measured: 1 year
Change in C-peptide
Measured: 1 year
Change in insulin dose
hyperglycemic and hypoglycemic events.
Measured: 1 year
Hyperglycemic and hypoglycemic events
Blood sugar level higher than 11.1 mmol/l or lower than 3.9 mmol/l.
Measured: 1 year
Life quality evaluation
Number of subjects with disturbance of emotion, sleep, resting or energy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 20 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
- NCT03011008
- Sponsor's protocol ID
- 0002
- Status last verified
- Mar 2020
- First submitted
- 2 Jan 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
Publications
Rondas D, D'Hertog W, Overbergh L, Mathieu C. Glucagon-like peptide-1: modulator of beta-cell dysfunction and death. Diabetes Obes Metab. 2013 Sep;15 Suppl 3:185-92. doi: 10.1111/dom.12165.
PubMed 24003936Chang TJ, Tseng HC, Liu MW, Chang YC, Hsieh ML, Chuang LM. Glucagon-like peptide-1 prevents methylglyoxal-induced apoptosis of beta cells through improving mitochondrial function and suppressing prolonged AMPK activation. Sci Rep. 2016 Mar 21;6:23403. doi: 10.1038/srep23403.
PubMed 26997114Mathieu C, Gillard P. Arresting type 1 diabetes after diagnosis: GAD is not enough. Lancet. 2011 Jul 23;378(9788):291-2. doi: 10.1016/S0140-6736(11)60978-1. Epub 2011 Jun 27. No abstract available.
PubMed 21715000
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
- Effect of Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03011008
- Acronym / sponsor ID
- 0002
- Conditions
- Type 1 Diabetes Mellitus, Autoimmune Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 5 Jan 2017 (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 purpose of this study is to investigate the therapeutic effect of Liraglutide on autoimmune diabetes.
Detailed description
Autoimmune Diabetes Mellitus (AIDM) is a subtype of diabetes mellitus caused by autoimmune destruction of beta cells in the islet, including Type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA). Insulin has been used as a routine therapy for AIDM to alleviate the hyperglycemic status, yet cannot effectively prevent the progressing destruction of beta cells or preserve its function. Glucagon-like peptide (GLP-1) analog Liraglutide has been tested in large-scale clinical trial to prove its various benefits for beta cells and glucolipid metabolism in Type 2 diabetes and obesity patients. However, its clinical application in AIDM is not well-defined so far. The aim of this study is to investigate the potential use of Liraglutide on glycemic control in AIDM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide + insulin | Experimental | Drug: Liraglutide, Drug: InsulinPatients will be subjected to a dose escalation of liraglutide up to 1.2 mg, then continue to receive the reached liraglutide dose once daily for 6 months thereafter. Insulin will be continued as routine therapy. |
| Insulin | Active comparator | Drug: InsulinPatients will receive insulin injection as a routine therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 diabetes according to ADA criteria <3 years.
- Age≥ 18 years.
- 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
Key exclusion criteria (11 listed)
- History or family history of medullary thyroid carcinoma or MEN 2 syndrome;
- History of chronic or acute pancreatitis;
- Allergic to liraglutide or any components in Victoza®;
- Hepatic abnormalities (transaminase > 2 times normal);
- Renal impairments (serum creatinine >133 umol/L);
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 |
|---|---|---|
| LiraglutideDose escalation of liraglutide starts from 0.6 mg up to 1.2 mg per day. | Drug | Liraglutide + insulin |
| InsulinReceive insulin following clinician's instruction. | Drug | Insulin, Liraglutide + insulin |
Primary outcome
Mean amplitude of glycemic excursions (MAGE)
Time frame: 1 year
MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this one-year study.
5 secondary outcomes
Change in HbA1C
Time frame: 1 year
Change in C-peptide
Time frame: 1 year
Change in insulin dose
Time frame: 1 year
Hyperglycemic and hypoglycemic events
Time frame: 1 year
Life quality evaluation
Time frame: 1 year
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.
- Background: PubMed 24003936Rondas D, D'Hertog W, Overbergh L, Mathieu C. Glucagon-like peptide-1: modulator of beta-cell dysfunction and death. Diabetes Obes Metab. 2013 Sep;15 Suppl 3:185-92. doi: 10.1111/dom.12165.
- Background: PubMed 26997114Chang TJ, Tseng HC, Liu MW, Chang YC, Hsieh ML, Chuang LM. Glucagon-like peptide-1 prevents methylglyoxal-induced apoptosis of beta cells through improving mitochondrial function and suppressing prolonged AMPK activation. Sci Rep. 2016 Mar 21;6:23403. doi: 10.1038/srep23403.
- Background: PubMed 21715000Mathieu C, Gillard P. Arresting type 1 diabetes after diagnosis: GAD is not enough. Lancet. 2011 Jul 23;378(9788):291-2. doi: 10.1016/S0140-6736(11)60978-1. Epub 2011 Jun 27. No abstract available.
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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 Liraglutide 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 5 inclusion and 11 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, MD/PhD (86-731-85292154, 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: 1 year). 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 NCT03011008, which also lists 3 linked publications.
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.