Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes (Cinétique DAPA)

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Completed

Phase 4

Conditions

Oral Antidiabetics

Type-2 Diabetes

Treatments

Drug: Placebos

Drug: Dapagliflozin

Study type

Interventional

Funder types

Other

Identifiers

NCT03269058

VERGES AZ 2015

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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