ITMO public health
Last update : 01/01/2019 | Version : 1 | ID : 146
| General | |
| Identification | |
| Detailed name | Observational study of the real-world usage, efficacy and safety of rosiglitazone in Type 2 diabetics |
| Sign or acronym | AVANCE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTIRS : 05.309 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Keywords | pharmaco-epidémiologY, rosiglitazone |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Phone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Unit | Laboratoire 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) |
Longitudinal study (except cohorts) |
| 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. |
Physicians are to be randomly selected from the CEGEDIM data base. To take stock of refusals, a pool will be constituted containing three times as many specialists and general practitioners as will eventually be required. Every physician in each pool (specialists and general practitioners) will be randomly attributed a number. Lists will then be compiled in ascending order, using this random number. Physicians will then be successively solicited in the order of appearance of their names on the list until the required number of general practitioners or specialists has been attained. The planned inclusion period is nine months. This duration could nevertheless be extended if there are recruitment problems, or curtailed if enough patients have been recruited. During this period, all the Investigating Physicians will be asked to include all patients they see (in consultations or home visits) who start or have recently started (within the previous 30 days) a course of rosiglitazone treatment and who have agreed to take part in the Study, until a maximum number of patients has been reached, namely 4 for the general practitioners and 5 for the specialists. Participating physicians will also be asked to fill out a non-inclusion record for every patient who was in theory eligible but was not included (with the reason for non-inclusion). |
| Database objective | |
| Main objective | To describe the profiles of patients being treated by general practitioners and specialists, compatibility of practice with the SPC, patient compliance, and the safety and efficacy of rosiglitazone in "real-world" conditions of use. |
| Inclusion criteria |
- Type 2 diabetic spontaneously consulting (i.e. independently of the study); - Patient who is starting or has recently started (within a month) a course of treatment with Avandia® or Avandamet®; - Patient who has given his/her consent to participate. |
| 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 |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2006 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1120 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | CRF and self administrated questionnaire |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Data will be collected at 5 stages : At inclusion After about 6 months (Follow-Up Visit 1):Up Visit 3) After about 12 months (Follow-Up Visit 2) After about 18 months (Follow-Up Visit 3) After about 24 months (End-of-Study Visit) |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publication in congress |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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