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

Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Type-2 Diabetes; Oral Antidiabetics
• Intervention / Treatment: Drug: Dapagliflozin; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • CHU Dijon Bourgogne
  • Nantes, France, 44093
    • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients not treated with statins	Drug: Dapagliflozin; Dapagliflozin 10 mg daily per os; Drug: Placebos; Placebo of Dapagliflozin per day per os
Experimental: Patients treated with statins	Drug: Dapagliflozin; Dapagliflozin 10 mg daily per os; Drug: Placebos; Placebo of Dapagliflozin per day per os

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline the rate of production of VLDL Apo B	15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of IDL Apo B	15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of LDL Apo B	15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of HDL Apo A1	15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B	15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B	15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of IDL Apo B	15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of LDL Apo B	15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1	15 days before treatment initiation, Day 0, Day 90 and Day 180

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2017
• Primary Completion (Actual): May 6, 2021
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: VERGES AZ 2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No