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Type1 Diabetes MellitusPhase 1/2NCT03011021

Safety and Efficacy of Umbilical Cord Blood Regulatory T Cells Plus Liraglutide on Autoimmune Diabetes

A Phase 1/2 study testing Liraglutide, UCB-Treg and Insulin in people with Type1 Diabetes Mellitus and Autoimmune Diabetes, run by Second Xiangya Hospital of Central South University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo expanded umbilical cord blood regulatory T cells adjunct with Liraglutide on autoimmune diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type1 Diabetes Mellitus, Autoimmune Diabetes
What is being tested?
Liraglutide, UCB-Treg and Insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Jan 2017to Jun 2025
Phase
Phase 1/2
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 anemia (Hb ≤100g/L), leukopenia (<3.5×109/L);
  • Presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets <100×109/L);
  • 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;
  • Presence of any kind of chronic infection or immune deficiency, including hepatitis B, hepatitis C, HIV, syphilis or tuberculosis, etc.;
  • Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months;
  • 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.

Zhiguang Zhou, MD/PhD contact

86-731-85292154

zhouzg@hotmail.com

China1 site, 1 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

    Recruiting

Other trials in China

About this study

Official title: Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells With Liraglutide on Autoimmune Diabetes

The purpose of this study is to investigate the safety and therapeutic effect of ex-vivo expanded umbilical cord blood regulatory T cells adjunct with 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. Regulatory T cells expanded from umbilical cord blood (UCB-Treg) ex-vivo have shown strong capacity to control immune responses in autoimmune diseases, offering a hopeful therapeutic way for AIDM. 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 with UCB-Treg infusion in AIDM and examine the safety and efficacy of this new therapy.

Being tested
Liraglutide, UCB-Treg, Insulin
Keywords
Autoimmune Diabetes, Umbilical Cord Blood Regulatory T Lymphocyte, Liraglutide
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.

  • UCB-TregBiological

    Receive Treg infusion: 1~5*10^6/kg b.w. in 100ml normal saline

  • InsulinDrug

    Receive insulin following clinician's instruction.

Study groups in NCT03011021
Study groupRoleWhat they receive
UCB-Treg plus LiraglutideExperimentalSubjects will receive a single infusion of ex vivo expanded umbilical cord blood derived Treg product (2 x 10^6). Dose escalation of liraglutide up to 1.2 mg will be started 3 days after Treg infusion only if no severe side effects showed. Subjects continue to receive the reached liraglutide dose once daily for 6 months thereafter. Insulin will be continued as a routine therapy.
Receives: Drug: Liraglutide; Biological: UCB-Treg; Drug: Insulin
UCB-TregActive comparatorSubjects will receive a single infusion of ex vivo expanded Treg product (2 x 10^6). Insulin will be continued as a routine therapy.
Receives: Biological: UCB-Treg; Drug: Insulin
LiraglutideActive comparatorPatients 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
InsulinActive comparatorPatients 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.

  1. Adverse effects

    Primary outcome measures will be the number of participants with adverse events, laboratory abnormalities and other signs of toxicity. Particular focus will be on the number and severity of infusion reactions, complications related to infection, and any potential negative impact on the course of diabetes.

    Measured: 2 years

Secondary outcomes (8)

  1. Change in HbA1C

    Measure the HbA1C level after treatment

    Measured: 2 years

  2. Change in C-peptide

    Measure the C-peptide level after treatment

    Measured: 2 years

  3. Change in insulin dose

    Measure insulin dose patient used after treatment

    Measured: 2 years

  4. Hypoglycaemic events

    Measure the number of participants with Hypoglycaemic events

    Measured: 2 years

  5. Change in titer of autoantibodies

    Measure the titer of antoantibodies of participant after treatment

    Measured: 2 years

  6. Change in immune cells diversities and quantities.

    Measure the immune cells diversities and quantities after treatment

    Measured: 2 years

  7. Change in autoimmune-related cytokines

    Measure the change of autoimmune- related cytokines after treatment

    Measured: 2 years

  8. Life quality evaluation

    Number of participants with disturbance of emotion, sleep, resting or energy.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03011021
Sponsor's protocol ID
0001
Status last verified
Mar 2023
First submitted
2 Jan 2017
Last updated
14 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Milward K, Issa F, Hester J, Figueroa-Tentori D, Madrigal A, Wood KJ. Multiple unit pooled umbilical cord blood is a viable source of therapeutic regulatory T cells. Transplantation. 2013 Jan 15;95(1):85-93. doi: 10.1097/TP.0b013e31827722ed.

    PubMed 23263503

  • Fan H, Yang J, Hao J, Ren Y, Chen L, Li G, Xie R, Yang Y, Gao F, Liu M. Comparative study of regulatory T cells expanded ex vivo from cord blood and adult peripheral blood. Immunology. 2012 Jun;136(2):218-30. doi: 10.1111/j.1365-2567.2012.03573.x.

    PubMed 22348606

  • Brunstein CG, Miller JS, Cao Q, McKenna DH, Hippen KL, Curtsinger J, Defor T, Levine BL, June CH, Rubinstein P, McGlave PB, Blazar BR, Wagner JE. Infusion of ex vivo expanded T regulatory cells in adults transplanted with umbilical cord blood: safety profile and detection kinetics. Blood. 2011 Jan 20;117(3):1061-70. doi: 10.1182/blood-2010-07-293795. Epub 2010 Oct 15.

    PubMed 20952687

  • 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 24003936

  • Chang 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 26997114

  • Zoso A, Serafini P, Lanzoni G, Peixoto E, Messinger S, Mantero A, Padilla-Tellez ND, Baidal DA, Alejandro R, Ricordi C, Inverardi L. G-CSF and Exenatide Might Be Associated with Increased Long-Term Survival of Allogeneic Pancreatic Islet Grafts. PLoS One. 2016 Jun 10;11(6):e0157245. doi: 10.1371/journal.pone.0157245. eCollection 2016.

    PubMed 27285580

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Liraglutide, UCB-Treg and Insulin in people with Type1 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 15 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 14 Mar 2023. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Adverse effects (time frame: 2 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 NCT03011021, which also lists 6 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 14 Mar 2023.

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