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Completed

NCT Number: NCT03269058

Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes

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.

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Key information

Conditions

Type-2 Diabetes Oral Antidiabetics

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • eGFR > 75 ml/min/1.73 m² 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

Treatment and study plan

Dapagliflozin

Drug

Dapagliflozin 10 mg daily per os

Placebos

Drug

Placebo of Dapagliflozin per day per os

Primary outcomes

  1. Change from baseline the rate of production of VLDL Apo B

    Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180

  2. Change from baseline the rate of production of IDL Apo B

    Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180

  3. Change from baseline the rate of production of LDL Apo B

    Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180

  4. Change from baseline the rate of production of HDL Apo A1

    Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180

  5. Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B

    Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180

  6. Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B

    Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180

  7. Change from baseline the Fractional Catabolic Rate of IDL Apo B

    Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180

  8. Change from baseline the Fractional Catabolic Rate of LDL Apo B

    Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180

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

    Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes

Acronym: Cinétique DAPA

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2017
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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