Type 2 Diabetes Mellitus (T2DM)ELDERLY-TNCT05607160
A Study to Observe How Insulin Glargine 300 U/ml is Working and is Tolerated in Elderly Patients ≥75 Years of Age With Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus (T2DM), run by Sanofi at 1 site in Germany.
Trial summary
Primary objective: Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice Secondary objective: Treatment satisfaction Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- 5 Oct 2022to 11 Dec 2023
- How long will I take part?
- 24 Weeks
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Type 2 diabetes patients 75 years or older, for whom the treating physician has decided to initiate or switch to a therapy with insulin glargin 300 U/ml as part of the routine clinical practice
Who may be able to join
- Type 2 diabetes mellitus (T2DM) with oral antidiabetic drug (OAD) ± Glucagon-like-peptide-1 receptor agonist (GLP-1-RA) ± basal insulin (other than insulin glargine 300 U/ml)
- Age ≥75 years incl. patients from outpatient and inpatient care forms
- Glycohaemoglobin (Hba1c) ≥8.0% and ≤11.0%
- Inadequate glycaemic control (HbA1c), defined by the treating physician
- Ability and willingness to perform fasting blood glucose (BG) measurements themselves or with the support of third parties
- Signed consent form
Who cannot join
- Type 1 diabetes mellitus
- Age <75 years
- Contraindications to insulin glargine 300 U/ml
- Short-acting insulin in medication
- Current participation in clinical research
- Life expectancy <1 year
Show all 9Show fewer
- Known alcohol or drug abuse
- Mini Mental State Examination Score ≤19
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ELDERLY-T: A Non-interventional, Multicentre, Prospective Observational Study on the Effectiveness and Safety of Insulin Glargine 300 U/ml in Elderly Patients ≥75 Years of Age With Type 2 Diabetes
Primary objective:
- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice
Secondary objective:
- Treatment satisfaction
Read the detailed description
Study duration per participant is expected to be approximately 24 weeks
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Medical subject headings
- Diabetes Mellitus, Type 2
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 |
|---|---|---|
| Cohort 1 | Type 2 diabetes patients >= 75 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving the HbA1c target value
Proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml
Measured: 6 months
Secondary outcomes (15)
Absolute change in treatment satisfaction total score, from baseline to month 6
Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score
Measured: Baseline to month 6
Absolute change in Diabetes-related quality of life total score, from baseline to month 6
The diabetes-related quality of life was measured using the ELDERLY questionnaire
Measured: Baseline to month 6
Absolute change in Geriatric Depression Scale (GDS) total score, from baseline to month 6
The GDS was measured using the GDS-4 item questionnaire
Measured: Baseline to month 6
Absolute proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml
Measured: 3 months
Relative proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml
Measured: 3 months
Absolute proportion of participants who achieve their individual fasting blood glucose (FBG) target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml
Measured: 3 months
Relative proportion of participants who achieve their individual fasting blood glucose (FBG) target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml
Measured: 3 months
Absolute proportion of participants who achieve their individual FBG target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml
Measured: 6 months
Relative proportion of participants who achieve their individual FBG target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml
Measured: 6 months
Absolute proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6
Measured: Baseline to month 3 and 6
Relative proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6
Measured: Baseline to month 3 and 6
Absolute proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6
Measured: Baseline to month 3 and 6
Relative proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6
Measured: Baseline to month 3 and 6
Absolute change in FBG (mg/dl, mmol/l), from baseline to month 3 and 6
Measured: Baseline to month 3 and 6
Absolute change in HbA1c (%), from baseline to month 3 and 6
Measured: Baseline to month 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start5 Oct 2022
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- 82 participants (actual)
- Target duration
- 24 Weeks
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
- NCT05607160
- Sponsor's protocol ID
- OBS16989
- Other IDs
- U1111-1280-6373
- Acronym
- ELDERLY-T
- Status last verified
- Apr 2024
- First submitted
- 31 Oct 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELDERLY-T: A Non-interventional, Multicentre, Prospective Observational Study on the Effectiveness and Safety of Insulin Glargine 300 U/ml in Elderly Patients ≥75 Years of Age With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05607160
- Acronym / sponsor ID
- ELDERLY-T / OBS16989
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 7 Nov 2022 (actual)
- 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:
- Glycemic control after initiation or switch to insulin glargine 300 U/ml in everyday clinical practice
Secondary objective:
- Treatment satisfaction
Detailed description
Study duration per participant is expected to be approximately 24 weeks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Type 2 diabetes patients >= 75 years |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Type 2 diabetes patients 75 years or older, for whom the treating physician has decided to initiate or switch to a therapy with insulin glargin 300 U/ml as part of the routine clinical practice
Key inclusion criteria (6 listed)
- Type 2 diabetes mellitus (T2DM) with oral antidiabetic drug (OAD) ± Glucagon-like-peptide-1 receptor agonist (GLP-1-RA) ± basal insulin (other than insulin glargine 300 U/ml)
- Age ≥75 years incl. patients from outpatient and inpatient care forms
- Glycohaemoglobin (Hba1c) ≥8.0% and ≤11.0%
- Inadequate glycaemic control (HbA1c), defined by the treating physician
- Ability and willingness to perform fasting blood glucose (BG) measurements themselves or with the support of third parties
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus
- Age <75 years
- Contraindications to insulin glargine 300 U/ml
- Short-acting insulin in medication
- Current participation in clinical research
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
Proportion of participants achieving the HbA1c target value
Time frame: 6 months
Proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml
15 secondary outcomes
Absolute change in treatment satisfaction total score, from baseline to month 6
Time frame: Baseline to month 6
Absolute change in Diabetes-related quality of life total score, from baseline to month 6
Time frame: Baseline to month 6
Absolute change in Geriatric Depression Scale (GDS) total score, from baseline to month 6
Time frame: Baseline to month 6
Absolute proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml
Time frame: 3 months
Relative proportion of participants achieving their individual HbA1c target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml
Time frame: 3 months
Absolute proportion of participants who achieve their individual fasting blood glucose (FBG) target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml
Time frame: 3 months
Relative proportion of participants who achieve their individual fasting blood glucose (FBG) target value (pre-defined by the treating physician) within 3 months of initiation or switch to insulin glargine 300 U/ml
Time frame: 3 months
Absolute proportion of participants who achieve their individual FBG target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml
Time frame: 6 months
Relative proportion of participants who achieve their individual FBG target value (pre-defined by the treating physician) within 6 months of initiation or switch to insulin glargine 300 U/ml
Time frame: 6 months
Absolute proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6
Time frame: Baseline to month 3 and 6
Relative proportion of participants who achieve their individual FBG and HbA1c target values, from baseline to month 3 and 6
Time frame: Baseline to month 3 and 6
Absolute proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6
Time frame: Baseline to month 3 and 6
Relative proportion of patients who achieve their individual FBG or HbA1c target value, from baseline to month 3 and 6
Time frame: Baseline to month 3 and 6
Absolute change in FBG (mg/dl, mmol/l), from baseline to month 3 and 6
Time frame: Baseline to month 3 and 6
Absolute change in HbA1c (%), from baseline to month 3 and 6
Time frame: Baseline to month 3 and 6
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 12 Apr 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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 Type 2 Diabetes Mellitus (T2DM), run by Sanofi at 1 site in Germany.
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 6 inclusion and 9 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 12 Apr 2024. 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 Germany. 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.
What does the primary outcome measure?
Proportion of participants achieving the HbA1c target value (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2024.