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Dapagliflozin Efficacy and Action in NASH (DEAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03723252
Recruitment Status : Recruiting
First Posted : October 29, 2018
Last Update Posted : April 8, 2019
Information provided by (Responsible Party):
Huijie Zhang, Nanfang Hospital of Southern Medical University

Brief Summary:
This is a multicentre, randomized, placebo-controlled trial to assess the efficacy and safety of dapagliflozin on improving non-alcoholic steatohepatitis as determined by liver biopsies and metabolic risk factors.

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: Dapagliflozin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Dapagliflozin in Non-alcoholic Steatohepatitis: a Multicentre, Randomized, Placebo-controlled Trial
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Experimental: Dapagliflozin group
Participants will receive dapagliflozin 10mg po qd.
Drug: Dapagliflozin
Participants will receive dapagliflozin 10mg po qd

Placebo Comparator: Placebo group
Participants will receive placebo po qd.
Drug: Placebo
Participants will receive placebo po qd

Primary Outcome Measures :
  1. Improvement in scored liver histological improvement over 12 months [ Time Frame: Baseline to 12 months ]

Secondary Outcome Measures :
  1. Resolution of NASH [ Time Frame: Baseline to 12 months ]
  2. Change in fibrosis score [ Time Frame: Baseline to 12 months ]
  3. Change in each component score in the NAS [ Time Frame: Baseline to 12 months ]
  4. Change in body weight [ Time Frame: Baseline to 12 months ]
  5. Change in waist circumference [ Time Frame: Baseline to 12 months ]
  6. Change in visceral fat [ Time Frame: Baseline to 12 months ]
  7. Change in liver fat [ Time Frame: Baseline to 12 months ]
  8. Change in HbA1C [ Time Frame: Baseline to 12 months ]
  9. Change in blood pressure [ Time Frame: Baseline to 12 months ]
  10. Change in serum lipids [ Time Frame: Baseline to 12 months ]
  11. Change in insulin resistance [ Time Frame: Baseline to 12 months ]
  12. Change in inflammatory markers of NASH [ Time Frame: Baseline to 12 months ]
  13. Change in health related quality of life scores (SF-12) [ Time Frame: Baseline to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women aged≥18 years;
  • Non-alcoholic steatohepatitis as determined by liver biopsies within 6 months;
  • Patients with T2DM at screening had to have stable glycaemic control (HbA1c <9.5%) .

Exclusion Criteria:

  1. Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
  2. A history of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
  3. Obstructive biliary disease;
  4. Having any medical condition that would affect metabolism (i.e. Cushing syndrome, known hyperthyroidism or hypothyroidism);
  5. Poor glucose control (defined as HbA1C≤ 9.5% within 3 months) if diagnosed with T2DM, or taking any antidiabetic medication that would affect metabolism or weight loss (i.e. TZD, GLP-1, DPP-4i or initially using insulin in the past 3 months);
  6. Taking any medication (i.e. cortisol, methotrexate)that would affect steatohepatitis for more than two weeks in the past year;
  7. Chronic kidney disease or severe impaired renal function (serum creatinine≥ 2.0mg/dl);
  8. Serum alanine aminotransferase (ALT) greater than 300U/L
  9. A history of Type 1 diabetes;
  10. A history of bladder cancer;
  11. Women who are pregnant or plan to become pregnant;
  12. Serious medical disease with likely life expectancy less than 5 years;
  13. Patients who cannot be followed for 24 months (due to a health situation or migration);
  14. Participation in other clinical trial in the 30 days before randomization;
  15. Patients who are unwilling or unable to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03723252

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Contact: Huijie Zhang, MD.PhD. +86-020-61641635
Contact: Jinjun Chen, MD.PhD. +86-020-62787310

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China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Huijie Zhang, MD,PhD    +86-020-61641635   
Contact: Jinjun Chen, MD,PhD    +86-020-62787310   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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Principal Investigator: Huijie Zhang, MD.PhD. Nanfang Hospital of Southern Medical University
Principal Investigator: Jinjun Chen, MD.PhD. Nanfang Hospital of Southern Medical University

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Responsible Party: Huijie Zhang, Clinical Professor, Nanfang Hospital of Southern Medical University Identifier: NCT03723252     History of Changes
Other Study ID Numbers: NFEC-2018-127
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Huijie Zhang, Nanfang Hospital of Southern Medical University:
Nonalcoholic Steatohepatitis
SGLT-2 inhibitor

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs