Status:
COMPLETED
Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Type-2 Diabetes
Oral Antidiabetics
Eligibility:
All Genders
30-65 years
Phase:
PHASE4
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 ant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03269058
Start Date
December 20 2017
End Date
May 6 2021
Last Update
February 23 2024
Active Locations (2)
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1
CHU Dijon Bourgogne
Dijon, France, 21079
2
CHU de Nantes
Nantes, France, 44093