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

Primary Purpose

Type 1 Diabetes Mellitus, Autoimmune Diabetes

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Liraglutide
Insulin
Sponsored by
Second Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liraglutide + insulin

Insulin

Arm Description

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.

Patients will receive insulin injection as a routine therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in HbA1C
Change in C-peptide
Change in insulin dose
hyperglycemic and hypoglycemic events.
Hyperglycemic and hypoglycemic events
Blood sugar level higher than 11.1 mmol/l or lower than 3.9 mmol/l.
Life quality evaluation
Number of subjects with disturbance of emotion, sleep, resting or energy.

Full Information

First Posted
January 2, 2017
Last Updated
March 17, 2020
Sponsor
Second Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT03011008
Brief Title
Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus
Official Title
Effect of Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Xiangya Hospital of Central South University

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Autoimmune Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide + insulin
Arm Type
Experimental
Arm Description
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.
Arm Title
Insulin
Arm Type
Active Comparator
Arm Description
Patients will receive insulin injection as a routine therapy.
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
Dose escalation of liraglutide starts from 0.6 mg up to 1.2 mg per day.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Receive insulin following clinician's instruction.
Primary Outcome Measure Information:
Title
Mean amplitude of glycemic excursions (MAGE)
Description
MAGE is measured by applying continuous glucose monitoring system (CGMS) on subjects in each follow-up of this one-year study.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in HbA1C
Time Frame
1 year
Title
Change in C-peptide
Time Frame
1 year
Title
Change in insulin dose
Description
hyperglycemic and hypoglycemic events.
Time Frame
1 year
Title
Hyperglycemic and hypoglycemic events
Description
Blood sugar level higher than 11.1 mmol/l or lower than 3.9 mmol/l.
Time Frame
1 year
Title
Life quality evaluation
Description
Number of subjects with disturbance of emotion, sleep, resting or energy.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiguang Zhou, MD/PhD
Phone
86-731-85292154
Email
zhouzg@hotmail.com
Facility Information:
Facility Name
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiguang Zhou, MD/PhD
Phone
86-731-85292154
Email
zhouzg@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24003936
Citation
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.
Results Reference
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PubMed Identifier
26997114
Citation
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.
Results Reference
background
PubMed Identifier
21715000
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. No abstract available.
Results Reference
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Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus

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