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Trial · Interventional

CompletedNot applicableRegistry data

Effect of Dulaglutide on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease

Short name D-LIFT

Overview

Status
Completed
Phase
Not applicable
Enrollment
60 participants (actual)
Sponsor
Medanta, The Medicity, India · Other
Design
Randomized · Single masking
Countries
1 country

India

Start
1 Jan 2019
Primary completion
14 Jan 2020
Completion
18 Feb 2020
First posted
18 Jul 2018
Last update posted
20 Feb 2020
Conditions
Non Alcoholic Fatty Liver Disease · Type2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. N/A

    D-LIFT

    NCT03590626

    1 Jan 2019 to 18 Feb 2020

Registry summary

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

This D-LIFT (Effect of dulaglutide on Liver Fat) trial is an investigator initiated, prospective, open label, randomized clinical study to examine the effect of dulaglutide 0.75 mg subcutaneously weekly for 4 weeks, followed by 1.5 mg weekly for 20 weeks when included in the standard treatment for type 2 diabetes vs. standard treatment for type 2 diabetes (minus dulaglutide) in patients with type 2 diabetes and NAFLD. Hepatic steatosis (intracellular fat accumulation in hepatocytes) will be measured by MRI-PDFF, a validated quantitative biomarker for liver fat. The study will be conducted according to the CONSORT guidelines. The patient population for the trial will be derived from Medanta-The Medicity Hospital endocrine out-patient clinic, who would primarily visit for management of type 2 diabetes and other co-morbidities. The study will be conducted in Medanta-The Medicity Hospital, Gurugram, Haryana, which is a tertiary care center in North India. Patients deemed eligible will be screened for the trial. The clinical trial protocol will be presented for approval to the institutional ethics review board. Informed written consent will be obtained from all the participants before enrolment into the study.

Interventions

  • DulaglutideDrug

Arms2

  • Experimental

    Dulaglutide group

    receive dulaglutide 0.75 mg weekly for 4 weeks followed by 1.5 mg weekly for 20 weeks plus standard treatment for type 2 diabetes

  • No intervention

    Control group

    receive standard treatment for type 2 diabetes and up titration of treatment will be done by anti-diabetic medicines other than the GLP-1 receptor agonist

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in liver fat

    Time frame · Baseline to 24 weeks

    Registry description

    change in liver fat quantified by MRI-PDFF in colocalized regions of interest (ROI) within each of the nine liver segments

Secondary outcomes(6)
  1. Change in Biochemical Markers

    Time frame · Basline to 24 weeks

    Registry description

    change in serum AST levels

  2. Change in Fibroscan Parameters

    Time frame · Basline to 24 weeks

    Registry description

    Change in liver stiffness measurement (LSM) in kPa

  3. Change in Fibroscan Parameters

    Time frame · Basline to 24 weeks

    Registry description

    Change in Controlled Attenuation Parameter (CAP) in dB/m

  4. change in cardiometabolic markers

    Time frame · Basline to 24 weeks

    Registry description

    change in cardiometabolic markers namely IL-1, TNF-alpha, hs-CRP, leptin, adiponectin and homocysteine and fibrosis markers

  5. Change in Biochemical Markers

    Time frame · Baseline to 24 weeks

    Registry description

    Change in serum ALT levels

  6. Change in Biochemical Markers

    Time frame · Baseline to 24 weeks

    Registry description

    change in serum GGT levels

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 · 2020

7 results

Effect of dulaglutide on liver fat in patients with type 2 diabetes and NAFLD: randomised controlled trial (D-LIFT trial).

Kuchay et al. 2020Diabetologiacited by 201

PMID 32865597DOI 10.1007/s00125-020-05265-7PUB-32865597

Rights unknown7 results

Indexing hint: Clinical trial · 2017

10 results

Effect of Liraglutide Therapy on Liver Fat Content in Patients With Inadequately Controlled Type 2 Diabetes: The Lira-NAFLD Study.

Petit et al. 2017The Journal of clinical endocrinology and metabolismcited by 168

PMID 27732328DOI 10.1210/jc.2016-2775PUB-27732328

Rights unknown10 results

Indexing hint: Randomized controlled trial · 2017

9 results

Reduction of visceral fat by liraglutide is associated with ameliorations of hepatic steatosis, albuminuria, and micro-inflammation in type 2 diabetic patients with insulin treatment: a randomized control trial.

Bouchi et al. 2017Endocrine journalcited by 93

PMID 27916783DOI 10.1507/endocrj.ej16-0449PUB-27916783

Full text at the publisher9 results

Indexing hint: Randomized controlled trial · 2015

11 results

Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2).

Giorgino et al. 2015Diabetes carecited by 203

PMID 26089386DOI 10.2337/dc14-1625PUB-26089386

Full text at the publisher11 results

Indexing hint: Randomized controlled trial · 2014

10 results

Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3).

Umpierrez et al. 2014Diabetes carecited by 272

PMID 24842985DOI 10.2337/dc13-2759PUB-24842985

Full text at the publisher10 results

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2014

Corrected

Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5).

Nauck et al. 2014Diabetes carecited by 227

PMID 24742660PMC4113177DOI 10.2337/dc13-2761PUB-24742660

Rights unknown

Indexing hint: Randomized controlled trial · 2014

Corrected

Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial.

Dungan et al. 2014Lancet (London, England)cited by 386

PMID 25018121DOI 10.1016/s0140-6736(14)60976-4PUB-25018121

Full text at the publisher

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultPatel NS, Peterson MR, Brenner DA, Heba E, Sirlin C, Loomba R. Association between novel MRI-estimated pancreatic fat and liver histology-determined steatosis and fibrosis in non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2013 Mar;37(6):630-9. doi: 10.1111/apt.12237. Epub 2013 Feb 5. PMID 23383649
  • ResultReeder SB, Cruite I, Hamilton G, Sirlin CB. Quantitative Assessment of Liver Fat with Magnetic Resonance Imaging and Spectroscopy. J Magn Reson Imaging. 2011 Oct;34(4):729-749. doi: 10.1002/jmri.22775. Epub 2011 Sep 16. PMID 22025886
  • ResultPermutt Z, Le TA, Peterson MR, Seki E, Brenner DA, Sirlin C, Loomba R. Correlation between liver histology and novel magnetic resonance imaging in adult patients with non-alcoholic fatty liver disease - MRI accurately quantifies hepatic steatosis in NAFLD. Aliment Pharmacol Ther. 2012 Jul;36(1):22-9. doi: 10.1111/j.1365-2036.2012.05121.x. Epub 2012 May 3. PMID 22554256
  • ResultLe TA, Chen J, Changchien C, Peterson MR, Kono Y, Patton H, Cohen BL, Brenner D, Sirlin C, Loomba R; San Diego Integrated NAFLD Research Consortium (SINC). Effect of colesevelam on liver fat quantified by magnetic resonance in nonalcoholic steatohepatitis: a randomized controlled trial. Hepatology. 2012 Sep;56(3):922-32. doi: 10.1002/hep.25731. Epub 2012 Jul 2. PMID 22431131
  • ResultLoomba R, Sirlin CB, Ang B, Bettencourt R, Jain R, Salotti J, Soaft L, Hooker J, Kono Y, Bhatt A, Hernandez L, Nguyen P, Noureddin M, Haufe W, Hooker C, Yin M, Ehman R, Lin GY, Valasek MA, Brenner DA, Richards L; San Diego Integrated NAFLD Research Consortium (SINC). Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial). Hepatology. 2015 Apr;61(4):1239-50. doi: 10.1002/hep.27647. Epub 2015 Feb 27. PMID 25482832

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. A man or woman, 20 years of age or above with the diagnosis of type 2 diabetes for at least 3 months who meets all of the following two criteria: 1. On standard anti-diabetic agents (metformin, DPP-4 inhibitors, sulphonylureas or insulin, in any combination) with an HbA1c of ≤ 7.0% and ≥10.0% (≤53 and ≥86 mmol/mol) at screening 2. Have documented hepatic steatosis (MRI-PDFF \>6%) on screening MRI-PDFF 2. Subjects must be medically stable on the basis of medical history, physical examination and laboratory investigations. 3. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol. 4. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study Exclusion Criteria: 1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy. 2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely. 3. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT) with a score ≥8, or alcohol consumption of more than 20 g per day in the case of women and more than 30 g per day in the case of men for at least three consecutive months during the previous 5 years. 4. Thyroid stimulating hormone (TSH) value that is either \< 0.45 mIU/L or \>10 mIU/L at Screening. Note: Subjects on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment. 5. Use of a PPARγ agonist \[e.g., a thiazolidinedione (pioglitazone\], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin) or another GLP-1 receptor agonist (e.g., liraglutide) within 24 weeks before the enrollment. 6. BMI ≥23 kg/m2 or ≤40 kg/m2. 7. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report. 8. Use of weight loss medication (prescription and/or over-the-counter) within 3 months prior to Screening or have participated in a weight loss/diet program within 12 months prior to Screening. 9. Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant. 10. Myocardial infarction, unstable angina, pulmonary hypertension, revascularisation procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3 months before Screening, or revascularisation procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease. 11. History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening. 12. Use of vitamin E within 3 months before screening. 13. History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection). 14. History of diabetic gastroparesis (or symptoms suggestive of this disorder, including postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any other chronic, clinically important gastrointestinal disorder. 15. Estimated glomerular filtration rate (eGFR) \<65 mL/min/1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation. 16. Subjects with a history of having or possibly having metallic material in the body or any contraindication for a MR examination. 17. Screening fasting serum triglycerides ≥600 mg/dL (6•74 mmol/L). 18. Claustrophobia, or anxiety related to previous negative experiences with magnetic resonance imaging procedures or if the subject is unwilling to participate in magnetic resonance imaging procedures. 19. Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening. 20. History of human immunodeficiency virus (HIV) antibody positive at Screening. 21. Major surgery (e.g., requiring general anaesthesia) within 12 weeks before Screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. 22. Contraindications to the use of dulaglutide (per DULAGLUTIDE US Prescribing Information). 23. Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication or an immunosuppressive agent. Note: Subjects using inhaled, intranasal, intra-articular, or topical corticosteroids, or corticosteroids in therapeutic replacement doses may participate. 24. Pregnancy or women breastfeeding or planning to become pregnant while enroled in this study. 25. History of significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. 26. Use of drugs known to cause hepatic steatosis like methotrexate

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