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Dapagliflozin on Hyperlipidemia and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS Study) (DAPHNIS)

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ClinicalTrials.gov Identifier: NCT02577159
Recruitment Status : Unknown
Verified January 2018 by Osaka University.
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Osaka University

Brief Summary:
The investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus whose HbA1c levels are less than 7.0% (from 20 to 65 years of age). The investigators will examine changes of fasting lipoprotein profile including TG, TC, HDL-C, apoB-48 and RemL-C before and after the 8 weeks administration of dapagliflozin.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Dapagliflozin Phase 4

Detailed Description:
In this study, the investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus. Primary Objective is to examine changes of fasting lipoprotein profile by the administration of dapagliflozin; Concentrations of apoB-48 and RemL-C. Secondary Objectives are; to examine changes of fasting glucose and HbA1c (NGSP) level by the administration of dapagliflozin, to examine changes of fasting lipid profile by the administration of dapagliflozin; Concentrations of TG, TC, HDL-C and LDL-C, to examine changes of fractions of free fatty acids, protein mass of LPL, and lipoprotein profile assessed by the HPLC by the administration of dapagliflozin, to examine changes of biomarkers for renal and hepatic function by the administration of dapagliflozin, and to examine the frequency of adverse effects by the administration of dapagliflozin. This study is open-label study and contains patients who are diabetes mellitus of from 20 to 65 years of age and their Patients who have not achieve the clinical target of the glycemic control (less than 7.0% in HbA1c).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS Study)
Study Start Date : July 1, 2015
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dapagliflozin
Diabetic patients who met the inclusion/exclusion criteria. Dapagliflozin is orally administered for 8 weeks in the dose of 5mg per day if there is no serious event included in termination criteria. If the effect for improving diabetes is insufficient, it is allowed to raise its dose up to 10mg/day.
Drug: Dapagliflozin
Dapagliflozin is orally administered for 8 weeks in the dose of 5mg per day by adding the conventional treatment if there is no serious event included in termination criteria. If the effect for improving diabetes is insufficient, it is allowed to raise its dose up to 10mg/day.
Other Name: conventional treatment




Primary Outcome Measures :
  1. Changes in fasting lipoprotein profiles [ Time Frame: at four and eight weeks after the administration of dapagliflozin ]
    Changes in fasting lipoprotein profiles including concentrations of apoA-1, apoA-2, apoB, apoB-48, apoC-2, apoC-3, apoE, RemL-C, free-fatty acids profile, LPL protein mass and lipoprotein profile assessed by the HPLC at four and eight weeks after the administration of dapagliflozin


Secondary Outcome Measures :
  1. Changes in fasting lipid profiles [ Time Frame: at four and eight weeks after the administration of dapagliflozin ]
    Changes in fasting lipid profiles including concentrations of triglyceride(TG), total cholesterol(TC), HDL-cholesterol (HDL-C) and LDL-C at four and eight weeks after the administration of dapagliflozin

  2. Changes in fasting blood glucose and HbA1c [ Time Frame: at four and eight weeks after the administration of dapagliflozin ]
    Changes in fasting blood glucose and HbA1c at four and eight weeks after the administration of dapagliflozin

  3. Changes in insulin and adiponectin [ Time Frame: at four and eight weeks after the administration of dapagliflozin ]
    Changes in other clinical profiles including concentrations of insulin and adiponectin

  4. Frequency of adverse side effects [ Time Frame: at four and eight weeks after the administration of dapagliflozin ]
    Frequency of adverse side effects at four and eight weeks after the administration of dapagliflozin

  5. Changes in biomarkers for renal and hepatic function [ Time Frame: four and eight weeks after the administration of dapagliflozin. ]
    Changes in biomarkers for renal and hepatic function at four and eight weeks after the administration of dapagliflozin.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects with type 2 diabetes mellitus of from 20 to 65 years of age.
  • Patients who have not achieve the clinical target of the glycemic control (less than 7.0% in HbA1c).
  • Patients who received the diet therapy, the exercise therapy or the following anti-diabetic drugs in addition to the diet and/or exercise therapy (up to two drugs) with dosage stable for 8 weeks prior to entry.
  • Sulfonylurea (Glymepiride 2mg/day or less, Glibenclamide 1.25mg/day or less, Gliclazide 40mg/day or less)
  • Thiazolidine (Actos)
  • Biguanide (Metformin, Buformin)
  • alpha-glucosidase inhibitor (Voglibose, Miglitol, Acarbose)
  • DPP4 inhibitors (Sitagliptin, Linagliptin, Anagliptin, Teneligliptin, Alogliptin, Saxagliptin)
  • Informed consent to participate in the study prior to any study procedures.

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Moderate or severe renal dysfunction (eGFR<45 ml/min/1.73m2 or hemodialysis)
  • Severe hepatic insufficiency (AST and/or ALT >3x upper limit of normal)
  • Adrenal insufficiency or pituitary gland dysfunction
  • Malnourishment, starvation, irregular dietary intake, poor dietary intake, debilitating condition or a severe muscle movement
  • Volume depleted patients; concomitant medication such as loop diuretics.
  • Excessive alcohol intake (>60g daily)
  • SGLT2 inhibitors such as dapagliflozin are already administered
  • Contraindication with dapagliflozin
  • Start a new medication of statins, fibrates, ezetimibe or probucol within a month
  • Females who are likely to be pregnant, during pregnancy or lactating
  • Participants in other clinical trials
  • Inability to communicate and comply with all study requirements.

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 ClinicalTrials.gov identifier (NCT number): NCT02577159


Locations
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Japan
Sousei Hospital
Kadoma, Osaka, Japan, 5710025
Osaka Central Hospital
Osaka city, Osaka, Japan, 5300001
Osaka University Hospital
Suita, Osaka, Japan, 5650871
Sponsors and Collaborators
Osaka University
Investigators
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Principal Investigator: Shizuya Yamashita, MD, PhD Osaka University Graduate School of Medicine
Publications:

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Responsible Party: Osaka University
ClinicalTrials.gov Identifier: NCT02577159    
Other Study ID Numbers: DAPHNIS
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: January 2018
Keywords provided by Osaka University:
sodium-glucose cotransporter 2 inhibitor
Diabetes Mellitus, Type 2
dyslipidemia
remnants
apolipoprotein B-48
Additional relevant MeSH terms:
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Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Hyperlipidemias
Hyperlipoproteinemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Dyslipidemias
Lipid Metabolism Disorders
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs