Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-03 @ 11:36 PM
Study NCT ID:
NCT03269058
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2017-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Study Overview
Official Title:
Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cinétique DAPA
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: