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

Primary Purpose

Type-2 Diabetes, Oral Antidiabetics

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Dapagliflozin

Placebos

About this trial

This is an interventional treatment trial for Type-2 Diabetes

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU Dijon BourgogneRecruiting
CHU de NantesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients not treated with statins

Patients treated with statins

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline the rate of production of VLDL Apo B

Change from baseline the rate of production of IDL Apo B

Change from baseline the rate of production of LDL Apo B

Change from baseline the rate of production of HDL Apo A1

Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B

Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B

Change from baseline the Fractional Catabolic Rate of IDL Apo B

Change from baseline the Fractional Catabolic Rate of LDL Apo B

Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1

Secondary Outcome Measures

Full Information

NCT ID

NCT03269058

First Posted

August 25, 2017

Last Updated

November 19, 2019

Sponsor

Centre Hospitalier Universitaire Dijon

1. Study Identification

Unique Protocol Identification Number

NCT03269058

Brief Title

Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes

Acronym

Cinétique DAPA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 20, 2017 (Actual)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type-2 Diabetes, Oral Antidiabetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients not treated with statins

Arm Type

Experimental

Arm Title

Patients treated with statins

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin

Intervention Description

Dapagliflozin 10 mg daily per os

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

Placebo of Dapagliflozin per day per os

Primary Outcome Measure Information:

Title

Change from baseline the rate of production of VLDL Apo B

Time Frame