ITMO public health
Last update : 08/17/2016 | Version : 1 | ID : 73265
| General | |
| Identification | |
| Detailed name | Cohort of Elderly Patients with T2D. Comparing the Risk of Hypoglycaemia in DPP4-Inhibitors (iDPP4) with Conventional Oral Antidiabetic Drugs as Add-On Therapy to Metformin. |
| Sign or acronym | HYPOCRAS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Pathology (details) | Type 2 diabetes |
| Health determinants |
Healthcare system and access to health care services Iatrogenic Nutrition |
| Keywords | type 2 diabetes; elderly subject; DPP4 inhibitors; oral antidiabetic drugs; hypoglycaemia |
| Scientific investigator(s) (Contact) | |
| Name of the director | Dejager |
| Surname | Sylvie |
| sylvie.dejager@psl.aphp.fr | |
| Unit | Biostatistics and Clinical Research Departments |
| Organization | Novartis Pharma |
| Name of the director | Penfornis |
| Surname | Alfred |
| Phone | +33 (0)3 81 66 82 29 |
| alfred.penfornis@ufc-chu.univ-fcomte.fr | |
| Unit | EA 3920 |
| Organization | Jean-Minjoz Hospital |
| Name of the director | Bourdel-Marchasson |
| Surname | Isabelle |
| Isabelle.bourdel-marchasson@chu-bordeaux.fr | |
| Organization | Bordeaux University Hospital |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Novartis Pharma |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Novartis Pharma |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Jean-Minjoz Hospital, Bordeaux University Hospital |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| 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. | Two cohorts were formed based on two prescribed drugs (either DPP4-i or another oral antidiabetic drug). |
| Database objective | |
| Main objective | HYPOCRAS aims to compare hypoglycaemic risk in dipeptidyl peptidase-4 inhibitors (iDPP4s) with other oral antidiabetic drugs (OAD) along with metaformin in the real-life treatment of elderly patients with type 2 diabetes (T2D). |
| Inclusion criteria | Patients eligible for the study were men and women of 65 years of age or over with T2D and HbA1c: ≥6.5% after a course of at least 3 months of metformin alone at a stable, maximum tolerated daily dose, requiring the prescription of a second OAD. Patients who had at least two follow-up visits planned over the next 6 months (± 1 month, 3 months, 6 months ± 1 month). |
| Population type | |
| Age |
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) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1,317 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Details of disease, treatment, hypoglycaemic episodes and glycated haemoglobin (HbA1c) level. Fasting plasma glucose (FPG). Weight fluctuation and patient satisfaction with regards to treatment. |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | By general practitioners |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Details on monitoring of participants | 6-month follow-up with interim visit at 3 months. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.diabet-metabolism.com/article/S1262-3636%2812%2971192-8/abstract |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/22996038 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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