Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes

Conditions

• Oral Antidiabetics
• Type-2 Diabetes

Eligibility Criteria

Sex

ALL

Age

30 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Dapagliflozin — DRUG
  Dapagliflozin 10 mg daily per os
• Placebos — DRUG
  Placebo of Dapagliflozin per day per os

Study Details

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.

Key Dates

Start date

Dec 20, 2017

Status verified

Mar 2026

Primary completion

May 6, 2021

Completion

May 6, 2021

Study Design

Enrollment

28 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Patients not treated with statins
• Experimental: Patients treated with statins

Primary Outcome Measure

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 ]