Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes

NCT ID: NCT03269058

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-20
• Study Completion Date: 2021-05-06

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.

Conditions

Type-2 Diabetes; Oral Antidiabetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Patients not treated with statins

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

Dapagliflozin 10 mg daily per os

Placebos

Intervention Type: DRUG

Placebo of Dapagliflozin per day per os

Patients treated with statins

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

Dapagliflozin 10 mg daily per os

Placebos

Intervention Type: DRUG

Placebo of Dapagliflozin per day per os

Interventions

Dapagliflozin

Dapagliflozin 10 mg daily per os

Intervention Type: DRUG

Placebos

Placebo of Dapagliflozin per day per os

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Dijon Bourgogne

Dijon, , France

CHU de Nantes

Nantes, , France

Countries

France

Other Identifiers

VERGES AZ 2015

Identifier Type: -

Identifier Source: org_study_id