ITMO public health
Last update : 09/07/2020 | Version : 1 | ID : 7440
| General | |
| Identification | |
| Detailed name | Profile of patients with type 2 diabetes newly treated with GLP1 analogues in France and Spain |
| Sign or acronym | CHADIG |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | DR-2013-268 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Medicine |
| Keywords | type 2 diabetes, GLP1, renally impaired population, France |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Address | 100 ROUTE DE VERSAILLES 78160 MARLY LE ROI |
| Phone | + 33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Unit | GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Laboratoire GSK |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | LABORATOIRE GSK |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
The selected practitioners will complete a questionnaire for the first 5 patients (on average) with type 2 diabetes that are prescribed for the first time a GLP1 analogue at a visit during the study period (three months).
Patients with a visit during the study period who recently initiated GLP1 analogue therapy (within 3 months prior to the visit) would be also enrolled in the survey if clinical data at initiation of the GLP1 treatment are available. |
| Database objective | |
| Main objective | describe the clinical characteristics of a representative cohort of patients with T2DM newly treated with GLP-1 analogues in France & Spain |
| Inclusion criteria |
adult ≥ 18 years, patient who accept to participate and who are able to read/understand the consent form and provide informed consent and who are not simultaneously participating in a study that included an investigational drug or procedure.
Patients with a visit during the study period who recently initiated GLP1 analogue therapy (within 3 months prior to the visit) would be also enrolled in the survey if clinical data at initiation of the GLP1 treatment are available |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | France &Spain |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 07/2013 |
| Date of last collection (YYYY or MM/YYYY) | 12/2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 800 :- 400 (France)- 400 (Espagne) |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | clinical dossier, medical exam |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | clinical dossier, medical exam |
| Biological data (detail) | HbA1c, lipid profile (total cholesterol, LDL, HDL, triglycerides), creatinine |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | e-CRF |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | publications |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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