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

August 27, 2018 updated by: Osaka University

Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS Study)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Kadoma, Osaka, Japan, 5710025
        • Sousei Hospital
      • Osaka city, Osaka, Japan, 5300001
        • Osaka Central Hospital
      • Suita, Osaka, Japan, 5650871
        • Osaka University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at four and eight weeks after the administration of dapagliflozin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at four and eight weeks after the administration of dapagliflozin
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
at four and eight weeks after the administration of dapagliflozin
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
at four and eight weeks after the administration of dapagliflozin
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
at four and eight weeks after the administration of dapagliflozin
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.
four and eight weeks after the administration of dapagliflozin.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osaka University

Investigators

  • Principal Investigator: Shizuya Yamashita, MD, PhD, Osaka University Graduate School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ANTICIPATED)

August 31, 2018

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (ESTIMATE)

October 16, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAPHNIS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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