Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes

  • STATUS
    Recruiting
  • days left to enroll
    48
  • participants needed
    28
  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 23 January 2021

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.

Details
Condition NIDDM, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, Oral Antidiabetics, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment placebos, Dapagliflozin
Clinical Study IdentifierNCT03269058
SponsorCentre Hospitalier Universitaire Dijon
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 30 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: NIDDM or Oral Antidiabetics?
Do you have any of these conditions: diabetes type 2 or Diabetes Mellitus Types I and II or NIDDM or Diabetes (Pediatric) or type 2 diabetes or Diabetes Mellitus Type 2 or type 2 diabetes...?
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/m
Triglycerides < 300 mg/dl
Half of the patients being treated with statins
eGFR > 75 ml/min/1.73 m at inclusion

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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