Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Dijon
• Treatments: Dapagliflozin

Criteria

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