Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus
NCT ID: NCT03011008
Last Updated: 2020-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2017-01-31
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Liraglutide + insulin
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.
Liraglutide
Dose escalation of liraglutide starts from 0.6 mg up to 1.2 mg per day.
Insulin
Receive insulin following clinician's instruction.
Insulin
Patients will receive insulin injection as a routine therapy.
Insulin
Receive insulin following clinician's instruction.
Interventions
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Liraglutide
Dose escalation of liraglutide starts from 0.6 mg up to 1.2 mg per day.
Insulin
Receive insulin following clinician's instruction.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.);
* 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.
18 Years
ALL
No
Sponsors
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Second Xiangya Hospital of Central South University
OTHER
Responsible Party
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Zhiguang Zhou
Principal Investigator
Locations
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Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Mathieu 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.
Other Identifiers
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0002
Identifier Type: -
Identifier Source: org_study_id
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