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

NCT03011008 | Unknown Phase 4

• 1 other identifier: 0002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus; Autoimmune Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in HbA1C

  1 year

• Change in C-peptide

  1 year

• Change in insulin dose

  1 year

• Hyperglycemic and hypoglycemic events

  1 year

• Life quality evaluation

  1 year

Study Arms (2)

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.

Drug: Liraglutide; Drug: Insulin

Insulin

ACTIVE COMPARATOR

Patients will receive insulin injection as a routine therapy.

Drug: Insulin

Interventions

Liraglutide DRUG

Dose escalation of liraglutide starts from 0.6 mg up to 1.2 mg per day.

Liraglutide + insulin

Insulin DRUG

Receive insulin following clinician's instruction.

Insulin; Liraglutide + insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 24003936 BACKGROUND

• 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.

  PMID: 26997114 BACKGROUND

• 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.

  PMID: 21715000 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Liraglutide; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Zhiguang Zhou, MD/PhD

CONTACT

86-731-85292154; zhouzg@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 5, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

CN (1)