NCT03269058

Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type-2 Diabetes
• Oral Antidiabetics

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin 10 mg daily per os
DRUG	Placebos	Placebo of Dapagliflozin per day per os

Timeline

• Start date: 2017-12-20
• Primary completion: 2021-05-06
• Completion: 2021-05-06
• First posted: 2017-08-31
• Last updated: 2026-03-05

Locations

1 site across 1 country: France