NCT03269058

Brief Summary

This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca. The information will:

  • reveal what is not working properly
  • make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning This biomedical research will take place at the University Hospitals of DIJON and NANTES.
  • 28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo.
  • The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months.
  • Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose.
  • Participation in the study will last 6 months and include 4 protocol visits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2021

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

August 25, 2017

Last Update Submit

March 4, 2026

Conditions

Type-2 DiabetesOral Antidiabetics

Outcome Measures

Primary Outcomes (9)

  • Change from baseline the rate of production of VLDL Apo B

    15 days before treatment initiation, Day 0, Day 90 and Day 180

  • Change from baseline the rate of production of IDL Apo B

    15 days before treatment initiation, Day 0, Day 90 and Day 180

  • Change from baseline the rate of production of LDL Apo B

    15 days before treatment initiation, Day 0, Day 90 and Day 180

  • Change from baseline the rate of production of HDL Apo A1

    15 days before treatment initiation, Day 0, Day 90 and Day 180

  • Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B

    15 days before treatment initiation, Day 0, Day 90 and Day 180

  • Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B

    15 days before treatment initiation, Day 0, Day 90 and Day 180

  • Change from baseline the Fractional Catabolic Rate of IDL Apo B

    15 days before treatment initiation, Day 0, Day 90 and Day 180

  • Change from baseline the Fractional Catabolic Rate of LDL Apo B

    15 days before treatment initiation, Day 0, Day 90 and Day 180

  • Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1

    15 days before treatment initiation, Day 0, Day 90 and Day 180

Study Arms (2)

Patients not treated with statins

EXPERIMENTAL
Drug: DapagliflozinDrug: Placebos

Patients treated with statins

EXPERIMENTAL
Drug: DapagliflozinDrug: Placebos

Interventions

DapagliflozinDRUG

Dapagliflozin 10 mg daily per os

Patients not treated with statinsPatients treated with statins
PlacebosDRUG

Placebo of Dapagliflozin per day per os

Patients not treated with statinsPatients treated with statins

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • persons who have provided written consent
  • type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors)
  • Stable treatment for 3 months
  • HbA1c between 7.5% and 10%
  • Age between 30 and 65 years
  • BMI between 25 and 35 kg/m²
  • Triglycerides \< 300 mg/dl
  • Half of the patients being treated with statins

You may not qualify if:

  • persons without national health insurance cover
  • patients treated with Insulin or a GLP-1 agonist
  • Patients under guardianship
  • patients treated with lipid-lowering drugs (except statins for 50% of patients)
  • kidney failure
  • liver failure or abnormal liver function ASAT or ALAT \>3 x upper limit of normal
  • total bilirubin \>2mg/dl
  • intestinal disease
  • serological evidence of an active liver infection (surface antigen of hepatitis B, hepatitis C antibodies, hepatitis B IgM antibodies)
  • Pregnancy, breastfeeding
  • hypersensitivity to the active substance or to excipients
  • patients with volume depletion, for example due to an acute disease (gastro-intestinal disease)
  • patients treated with loop diuretics or thiazides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Interventions

dapagliflozin

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 31, 2017

Study Start

December 20, 2017

Primary Completion

May 6, 2021

Study Completion

May 6, 2021

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

FR(1)