Skip to content

Trial · Interventional

CompletedPhase 4Registry data

Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes

NCTNCT02303730 (opens ClinicalTrials.gov in a new tab)Other idESR-14-10096
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
76 participants (actual)
Sponsor
Fudan University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Mar 2015
Primary completion
Nov 2017
Completion
Nov 2017
First posted
1 Dec 2014 (estimated)
Last update posted
28 Aug 2019
Conditions
Diabetes Mellitus, Type 2 · Non-alcoholic Fatty Liver Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

    Exenatide Compared With Insulin Glargine to Change Liver Fat Content in Type 2 Diabetes

    NCT02303730

    Mar 2015 to Nov 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate whether exenatide is superior to insulin glargine (after 24 weeks) in reducing liver fat content (by MRS) in patients with newly diagnosed type 2 diabetes mellitus and concomitant non-alcoholic fatty-liver disease(NAFLD).

Interventions

  • ExenatideDrug
  • insulin glargineDrug

Arms2

  • Experimental

    Exenatide

    Exenatide 5 ug twice daily 1 hour before meal subcutaneously for 4 weeks, then add to 10 ug twice daily 1 hour before meal subcutaneously for another 20 weeks

  • Active comparator

    Insulin glargine

    Insulin glargine subcutaneously, once daily, for 24 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in liver fat content（%） measured by MRS

    Time frame · baseline and 24 weeks

    Registry description

    Change in liver fat content（%） measured by MRS

Secondary outcomes(4)

  1. Change in intra-abdominal visceral fat content (cm2), abdominal subcutaneous fat content (cm2), and ratio between intra-abdominal visceral fat and subcutaneous fat area by MRI

    Time frame · baseline and 24 weeks

    Registry description

    Change in intra-abdominal visceral fat content (cm2), abdominal subcutaneous fat content (cm2), and ratio between intra-abdominal visceral fat and subcutaneous fat area by MRI

  2. Change in glucose metabolism (fasting blood glucose, postprandial plasma glucose, HbA1c)

    Time frame · baseline and 24 weeks

    Registry description

    Change in glucose metabolism (fasting blood glucose, postprandial plasma glucose, HbA1c)

  3. Change in blood lipid profile (total cholesterol, triglyceride, HDL, LDL)

    Time frame · baseline and 24 weeks

    Registry description

    Change in blood lipid profile (total cholesterol, triglyceride, HDL, LDL)

  4. Change in body weight,waist circumference and hip circumference

    Time frame · baseline and 24 weeks

    Registry description

    Change in body weight,waist circumference and hip circumference

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Randomized controlled trial · 2023

4 results

Insulin Glargine is More Suitable Than Exenatide in Preventing Muscle Loss in Non-Obese Type 2 Diabetic Patients with NAFLD.

Liu et al. 2023Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Associationcited by 4

PMID 37524110PMC10645484DOI 10.1055/a-2145-1004PUB-37524110

Free to read · publisher termsCC BY-NC-ND4 results
Read at sourceSee results (4)

Indexing hint: Randomized controlled trial · 2015

5 results

Comparison of the effects on glycaemic control and β-cell function in newly diagnosed type 2 diabetes patients of treatment with exenatide, insulin or pioglitazone: a multicentre randomized parallel-group trial (the CONFIDENCE study).

Xu et al. 2015Journal of internal medicinecited by 46

PMID 25039675DOI 10.1111/joim.12293PUB-25039675

Rights unknown5 results
Source linkSee results (5)

Indexing hint: Randomized controlled trial · 2014

15 results

Benefits of exenatide on obesity and non-alcoholic fatty liver disease with elevated liver enzymes in patients with type 2 diabetes.

Shao et al. 2014Diabetes/metabolism research and reviewscited by 158

PMID 24823873DOI 10.1002/dmrr.2561PUB-24823873

Full text at the publisher15 results
Publisher pageSee results (15)

Indexing hint: Randomized controlled trial · 2011

6 results

Effects of combined exenatide and pioglitazone therapy on hepatic fat content in type 2 diabetes.

Sathyanarayana et al. 2011Obesity (Silver Spring, Md.)cited by 102

PMID 21660077DOI 10.1038/oby.2011.152PUB-21660077

Full text at the publisher6 results
Publisher pageSee results (6)

PubMed tag: none · 2010

9 results

Effects of exenatide on systolic blood pressure in subjects with type 2 diabetes.

Okerson et al. 2010American journal of hypertensioncited by 139

PMID 20019672DOI 10.1038/ajh.2009.245PUB-20019672

Rights unknown9 results
Source linkSee results (9)

More studies

2 studies on this page

PubMed tag: none · 2012

Improved glycaemia correlates with liver fat reduction in obese, type 2 diabetes, patients given glucagon-like peptide-1 (GLP-1) receptor agonists.

Cuthbertson et al. 2012PloS onecited by 186

PMID 23236362PMC3516516DOI 10.1371/journal.pone.0050117PUB-23236362

CC BY
Download PDF

PubMed tag: none · 2011

GLP-1 analogs reduce hepatocyte steatosis and improve survival by enhancing the unfolded protein response and promoting macroautophagy.

Sharma et al. 2011PloS onecited by 228

PMID 21957486PMC3177901DOI 10.1371/journal.pone.0025269PUB-21957486

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female, 18 ≤ age ≤ 70 years old. * Newly diagnosed type 2 diabetes mellitus (WHO Diagnostic criteria for diabetes mellitus, 1999). * Patients with NAFLD, MRS measurement of liver fat content\> 10%. * 7% ≤ HbA1c ≤ 10% * No heavy drinking history within the last 5 years (alcohol intake: male \< 20 g/d, female \< 10 g/d) * HBsAg (-), hepatitis C virus antibody (HCV-Ab) (-) * BMI ≥ 24 kg/m2; Exclusion Criteria: * Pregnancy, lactation, intended pregnancy, or failure to take adequate contraceptive measures taken (contraception measures including sterilization, intrauterine device, oral contraceptives, and persistent use of condoms). * Type 1 diabetes mellitus, gestational diabetes mellitus or other special types of diabetes. * Liver and renal dysfunction (ALT or aspartate aminotransferase(AST) is 2.5 times higher than the upper limit of normal, or total bilirubin is 1.5 times higher than the upper limit of normal, or Cr ≥ 115 μmol/L). * increased amylase (blood amylase is 2.5 times higher than the upper limit of normal) or presence of gastrointestinal disease. * Use of drugs that may affect liver fat content within one month before or during the trial period, such as glucocorticoids, thyroid hormone, etc. * Use of GLP-1 receptor agonist, dipeptidyl peptidase -4 (DPP-4) inhibitors or insulin within 3 months before enrolment * Presence of serious dyslipidemia or other endocrine diseases (hypothyroidism, hypothalamic-pituitary dysfunction, etc). * Fatty liver caused by viral hepatitis, drug, alcohol, Wilson disease or total parenteral nutrition. * Presence of liver cancer, infection, biliary tract disease or recently increased liver enzyme due to medication. * Participation in strenuous exercise or administration of any drugs that affect glucose metabolism. * History of pancreatitis, alcohol abuse, metal disorders or history of allergy to investigational drug. * Congestive heart failure defined as New York Heart Association (NYHA) class III or IV, unstable angina or myocardial infarction in recent 6 months. * Any situation that may affect the implementation or results of the study.

PepBank is a research reference. Talk to a doctor before you use any peptide.