Diabetes Mellitus, Type 2NCT01065909
Observatory on Elderly Patients "Les S.AGES"
An observational study of Diabetes Mellitus, Type 2 and Chronic Pain, run by Sanofi at 1 site in France.
Trial summary
Primary objective shared by the 3 registries : Describe the different pharmacotherapeutic management in patients : DB (Diabetes): with type 2 diabetes, treated with oral and / or injectable antidiabetics CP (Chronic Pain): with any disease leading to chronic pain (lasting for more than 3 months) AF (Atrial… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Chronic Pain, Atrial Fibrillation
- How many people
- 3,491 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Ambulatory primary care patient over 65 years
Who may be able to join
- DB : Established type 2 diabetes treated with oral and / or injectable antidiabetics
- CP : Pain lasting for over 3 months, requiring therapeutic care
- FA : Ongoing Atrial fibrillation or AF diagnosed within the 12 months before enrollment and documented by ECG or Holter ECG, whatever the rhythm at inclusion
Who cannot join
- Living in accommodation facility for dependent patients
- Patient with non cardiovascular progressively unstable disease
- Patient already enrolled in a clinical trial
- Patient unlikely to complete the study
- Transitional AF due to thyrotoxicosis, alcohol, myocarditis, pericarditis, acute myocardial infarction, pulmonary embolism, metabolic disorders or electrocution, Post cardiac surgery AF (<3 months).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Observatory on the Therapeutic Management in Ambulatory Care Patients Aged 65 and Over, With Diabetes Type 2, Chronic Pain or Atrial Fibrillation
Primary objective shared by the 3 registries : Describe the different pharmacotherapeutic management in patients :
- DB (Diabetes): with type 2 diabetes, treated with oral and / or injectable antidiabetics
- CP (Chronic Pain): with any disease leading to chronic pain (lasting for more than 3 months)
- AF (Atrial Fibrillation): with ongoing AF or AF diagnosed within 12 months before enrollment
Read more
Secondary objectives shared by the 3 observatories:
- Describe the occurrence of clinical events, hospitalizations and death, according to the different medical care conditions, and analyze their predicting factors
- Estimate the resources consumption according to the medical and non medical management of these patients,
- Analyze the impact of some factors (patient's cognitive status, autonomy, renal function ...) on the current practice
Secondary objectives specific shared by DB and AF registries :
- Analyze the geriatric pharmaco-genetic aspects
Specific secondary objectives for each observatory :
- DB : Describe HbA1c level, percentage of responders and body weight evolution according to the different medical care conditions
- CP : Evaluate pain consequences on Daily Living Activities and patient autonomy
- Conditions
- Diabetes Mellitus, Type 2, Chronic Pain, Atrial Fibrillation
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronic Pain, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes type 2 | Not described | |
| Chronic Pain | Not described | |
| Atrial Fibrillation | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startMay 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065909
- Sponsor's protocol ID
- DIREG_L_04182
- Status last verified
- Oct 2014
- First submitted
- 8 Feb 2010
- Last updated
- 3 Oct 2014
- Results posted
- No
Publications
Strumia M, Vidal JS, Cestac P, Sallerin B, Andrieu S, Hanon O, Rouch L; S.AGES investigators *. Blood Pressure Postural Changes Variability Is Associated With Lower Cognition: The S.AGES Cohort. J Am Heart Assoc. 2025 Oct 7;14(19):e039197. doi: 10.1161/JAHA.124.039197. Epub 2025 Oct 8.
PubMed 41059541Baudouin E, Colle R, Becquemont L, Corruble E, Duron E. Association between driving and depression in older adults: findings from an ancillary study of a prospective cohort. BMC Geriatr. 2025 Mar 14;25(1):173. doi: 10.1186/s12877-025-05826-8.
PubMed 40087594Zitoun S, Baudouin E, Corruble E, Vidal JS, Becquemont L, Duron E. Use of potentially driver-impairing drugs among older drivers. BMC Geriatr. 2022 Jan 3;22(1):4. doi: 10.1186/s12877-021-02726-5.
PubMed 34979970Hanon O, Vidal JS, Pisica-Donose G, Benattar-Zibi L, Bertin P, Berrut G, Corruble E, Derumeaux G, Falissard B, Forette F, Pasquier F, Pinget M, Ourabah R, Becquemont L, Danchin N; S.AGES Investigators. Therapeutic management in ambulatory elderly patients with atrial fibrillation: the S.AGES cohort. J Nutr Health Aging. 2015 Feb;19(2):219-27. doi: 10.1007/s12603-015-0444-9.
PubMed 25651449Bucher S, Bauduceau B, Benattar-Zibi L, Bertin P, Berrut G, Corruble E, Danchin N, Delespierre T, Derumeaux G, Doucet J, Falissard B, Forette F, Hanon O, Ourabah R, Pasquier F, Piedvache C, Pinget M, Ringa V, Becquemont L; S.AGES Investigators. Primary care management of non-institutionalized elderly diabetic patients: The S.AGES cohort - Baseline data. Prim Care Diabetes. 2015 Aug;9(4):267-74. doi: 10.1016/j.pcd.2014.07.004. Epub 2014 Jul 31.
PubMed 25086913Bertin P, Becquemont L, Corruble E, Derumeaux G, Falissard B, Hanon O, Pinget M, Forette F. The therapeutic management of chronic pain in ambulatory care patients aged 65 and over in France: the S.AGES Cohort. Baseline data. J Nutr Health Aging. 2013;17(8):681-6. doi: 10.1007/s12603-013-0338-7.
PubMed 24097022
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Observatory on the Therapeutic Management in Ambulatory Care Patients Aged 65 and Over, With Diabetes Type 2, Chronic Pain or Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01065909
- Acronym / sponsor ID
- DIREG_L_04182
- Conditions
- Diabetes Mellitus, Type 2, Chronic Pain, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,491 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective shared by the 3 registries : Describe the different pharmacotherapeutic management in patients :
- DB (Diabetes): with type 2 diabetes, treated with oral and / or injectable antidiabetics
- CP (Chronic Pain): with any disease leading to chronic pain (lasting for more than 3 months)
- AF (Atrial Fibrillation): with ongoing AF or AF diagnosed within 12 months before enrollment
Secondary objectives shared by the 3 observatories:
- Describe the occurrence of clinical events, hospitalizations and death, according to the different medical care conditions, and analyze their predicting factors
- Estimate the resources consumption according to the medical and non medical management of these patients,
- Analyze the impact of some factors (patient's cognitive status, autonomy, renal function ...) on the current practice
Secondary objectives specific shared by DB and AF registries :
- Analyze the geriatric pharmaco-genetic aspects
Specific secondary objectives for each observatory :
- DB : Describe HbA1c level, percentage of responders and body weight evolution according to the different medical care conditions
- CP : Evaluate pain consequences on Daily Living Activities and patient autonomy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetes type 2 | – | – |
| Chronic Pain | – | – |
| Atrial Fibrillation | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Ambulatory primary care patient over 65 years
Key inclusion criteria (3 listed)
- DB : Established type 2 diabetes treated with oral and / or injectable antidiabetics
- CP : Pain lasting for over 3 months, requiring therapeutic care
- FA : Ongoing Atrial fibrillation or AF diagnosed within the 12 months before enrollment and documented by ECG or Holter ECG, whatever the rhythm at inclusion
Key exclusion criteria (6 listed)
- Living in accommodation facility for dependent patients
- Patient with non cardiovascular progressively unstable disease
- Patient already enrolled in a clinical trial
- Patient unlikely to complete the study
- Transitional AF due to thyrotoxicosis, alcohol, myocarditis, pericarditis, acute myocardial infarction, pulmonary embolism, metabolic disorders or electrocution, Post cardiac surgery AF (<3 months).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- Derived from this study: PubMed 41059541Strumia M, Vidal JS, Cestac P, Sallerin B, Andrieu S, Hanon O, Rouch L; S.AGES investigators *. Blood Pressure Postural Changes Variability Is Associated With Lower Cognition: The S.AGES Cohort. J Am Heart Assoc. 2025 Oct 7;14(19):e039197. doi: 10.1161/JAHA.124.039197. Epub 2025 Oct 8.
- Derived from this study: PubMed 40087594Baudouin E, Colle R, Becquemont L, Corruble E, Duron E. Association between driving and depression in older adults: findings from an ancillary study of a prospective cohort. BMC Geriatr. 2025 Mar 14;25(1):173. doi: 10.1186/s12877-025-05826-8.
- Derived from this study: PubMed 34979970Zitoun S, Baudouin E, Corruble E, Vidal JS, Becquemont L, Duron E. Use of potentially driver-impairing drugs among older drivers. BMC Geriatr. 2022 Jan 3;22(1):4. doi: 10.1186/s12877-021-02726-5.
- Derived from this study: PubMed 25651449Hanon O, Vidal JS, Pisica-Donose G, Benattar-Zibi L, Bertin P, Berrut G, Corruble E, Derumeaux G, Falissard B, Forette F, Pasquier F, Pinget M, Ourabah R, Becquemont L, Danchin N; S.AGES Investigators. Therapeutic management in ambulatory elderly patients with atrial fibrillation: the S.AGES cohort. J Nutr Health Aging. 2015 Feb;19(2):219-27. doi: 10.1007/s12603-015-0444-9.
- Derived from this study: PubMed 25086913Bucher S, Bauduceau B, Benattar-Zibi L, Bertin P, Berrut G, Corruble E, Danchin N, Delespierre T, Derumeaux G, Doucet J, Falissard B, Forette F, Hanon O, Ourabah R, Pasquier F, Piedvache C, Pinget M, Ringa V, Becquemont L; S.AGES Investigators. Primary care management of non-institutionalized elderly diabetic patients: The S.AGES cohort - Baseline data. Prim Care Diabetes. 2015 Aug;9(4):267-74. doi: 10.1016/j.pcd.2014.07.004. Epub 2014 Jul 31.
- Derived from this study: PubMed 24097022Bertin P, Becquemont L, Corruble E, Derumeaux G, Falissard B, Hanon O, Pinget M, Forette F. The therapeutic management of chronic pain in ambulatory care patients aged 65 and over in France: the S.AGES Cohort. Baseline data. J Nutr Health Aging. 2013;17(8):681-6. doi: 10.1007/s12603-013-0338-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Chronic Pain, run by Sanofi at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01065909, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2014.