Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Effect of Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03011008
• Other study ID #: 0002
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: June 2021

Study information

• Verified date: March 2020
• Source: Second Xiangya Hospital of Central South University
• Contact: Zhiguang Zhou, MD/PhD
• Phone: 86-731-85292154
• Email: zhouzg[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the therapeutic effect of Liraglutide on autoimmune diabetes.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.);

• 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.

Related Conditions & MeSH terms

• Autoimmune Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Liraglutide
Dose escalation of liraglutide starts from 0.6 mg up to 1.2 mg per day.
• Insulin
Receive insulin following clinician's instruction.

Locations

Country	Name	City	State
China	Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Erratum in: Sci Rep. 2016 May 31;6:26917. — View Citation

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. — View Citation

Rondas D, D'Hertog W, Overbergh L, Mathieu C. Glucagon-like peptide-1: modulator of ß-cell dysfunction and death. Diabetes Obes Metab. 2013 Sep;15 Suppl 3:185-92. doi: 10.1111/dom.12165. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	Change in HbA1C		1 year
Secondary	Change in C-peptide		1 year
Secondary	Change in insulin dose	hyperglycemic and hypoglycemic events.	1 year
Secondary	Hyperglycemic and hypoglycemic events	Blood sugar level higher than 11.1 mmol/l or lower than 3.9 mmol/l.	1 year
Secondary	Life quality evaluation	Number of subjects with disturbance of emotion, sleep, resting or energy.	1 year