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Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes

NCT03269058 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-03-05

No results posted yet for this study

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

Interventions

DRUG

Dapagliflozin

Dapagliflozin 10 mg daily per os

DRUG

Placebos

Placebo of Dapagliflozin per day per os

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2021-05-06
Completion
2021-05-06

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03269058 on ClinicalTrials.gov