AzTrials
AzTrials

Type2DiabetesSOLDMiDiab02NCT05477017

Evaluation of SGLT2-i Effectivness and Safety in Elderly Type 2 Diabetes Patients

An observational study of Type2Diabetes, run by University of Milan at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The aim of the study is to evaluate the benefits, documented in experimental settings, of treatment with SGLT2-i in subjects with type 2 diabetes and older than 70 years in normal clinical practice. The type of study does not involve immediate risks or direct benefits for the subjects taking part in it. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Type2Diabetes
What is being tested?
SGLT2 inhibitor
How many people
800 participants
Where
1 siteItaly
Study dates
Sep 2022to Mar 2023
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Elderly with type 2 diabetes receiving SGLT2-i therapy

Who may be able to join

  • Informed consent issued before any other activity related to the study (i.e. any activity related to data collection according to the study protocol);
  • Diagnosis of type II diabetes mellitus, according to ADA indications for at least 3 months
  • Males or females > 70 years old
  • Stable therapy for at least 3 months with oral hypoglycemic agents / insulin
  • Prescription of SGLT2 inhibitors, in accordance with normal clinical practice and local drug prescription / reimbursement guidelines.

Who cannot join

  • Mental incapacity, unavailability or language barriers that preclude adequate understanding or cooperation;
  • Diagnosis of type 1 diabetes mellitus, MODY (maturity-onset diabetes of the young), LADA (latent autoimmune diabetes in adults), gestational diabetes mellitus, secondary diabetes mellitus or any other hyperglycemic state other than T2D;
  • Previous participation in the study. Participation is defined by having given informed consent to the study;
  • Participation in another clinical study on T2D that includes any clinical intervention or administration of an investigational drug within 3 months prior to enrollment in the study

Trial locations and contacts

1 site in 1 country.

Elio Ippolito, MS contact

0239042648

elio.ippolito@unimi.it

MariaElena Lunati, MD contact

mariaelena.lunati@asst-fbf-sacco.it

Italy1 site

  • ASST FBF Sacco

    Milan, 20157

Other trials in Italy

About this study

Official title: Prospective Observational Cohort Study to Evaluate the Benefits, Documented in the Experimental Settings, of Treatment With SGLT2-i in Normal Clinical Practice, in Subjects With Type 2 Diabetes and Older Than 70 Years.

The aim of the study is to evaluate the benefits, documented in experimental settings, of treatment with SGLT2-i in subjects with type 2 diabetes and older than 70 years in normal clinical practice.

The type of study does not involve immediate risks or direct benefits for the subjects taking part in it. The potential benefits for clinicians and healthcare systems are: greater knowledge of diabetic disease and the study of new treatment options. However, the analysis of the data will allow us to better identify which patients benefit most from treatment with glycosurics.

Read the detailed description

Sodium-glucose co-transporter-2 inhibitors (SGLT2i) may have important benefits for the elderly with type 2 diabetes (T2D), however some safety concerns still limit their use in patients over 70 years of age. The SOLD study (SGLT2-i in Older Diabetic patients) aim to evaluate which basal characteristics of the patients are more frequently related to the suspension of treatment with SGLT2-i in a real-life setting.

Conditions
Type2Diabetes
Being tested
SGLT2 inhibitor
Keywords
SGLT2-inhibitors, Elderly, Safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGLT2 inhibitorDrug

    Also called Jardiance, Synjardy, Forxiga, Xigduo

    Selective inhibitors of the sodium and glucose co-transporter 2 (SGLT2) originated as antidiabetic drugs thanks to their hypoglycemic and glycosuric effect.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Variation in HbA1c values (% -point)

    Variation in HbA1c values (% -point) from baseline to 12 months from enrollment

    Measured: From Baseline to 12 months

Secondary outcomes (10)

  1. Evaluation of the maintenance of glycemic compensation

    Evaluation of the maintenance of glycemic compensation after the initiation of glycosuric therapy in clinical practice

    Measured: From Baseline to 12 months

  2. Evaluation of fasting glycemic control

    Evaluation of fasting glycemic control (mg/dl)

    Measured: From Baseline to 12 months

  3. Evaluation of the weight

    Evaluation of the weight (Kg)

    Measured: From Baseline to 12 months

  4. Evaluation of the BMI

    Evaluation of the BMI (Kg/m2)

    Measured: From Baseline to 12 months

  5. Evaluation of the waist circumference

    Evaluation of the waist circumference (cm)

    Measured: From Baseline to 12 months

  6. Evaluation of the systolic and diastolic pressure

    Evaluation of the systolic and diastolic pressure (mmHg)

    Measured: From Baseline to 12 months

  7. Evaluation of the heart rate

    Evaluation of the heart rate (bpm)

    Measured: From Baseline to 12 months

  8. Evaluation of the serum creatinine

    Evaluation of the serum creatinine (mg/dl)

    Measured: From Baseline to 12 months

  9. Evaluation of the e-GFR

    Evaluation of the e-GFR (mL/min/1.73m2)

    Measured: From Baseline to 12 months

  10. Evaluation of the main side effects and the withdrawal rate

    Evaluation of the main side effects and the withdrawal ratein the first year of treatment. It will be evalueted through scheduled clinical visit

    Measured: From Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study startSep 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionMar 2023 (estimated)

Resources

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
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05477017
Sponsor's protocol ID
03/2022
Acronym
SOLDMiDiab02
Status last verified
Jul 2022
First submitted
23 May 2022
Last updated
28 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • American Diabetes Association. 12. Older Adults: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S139-S147. doi: 10.2337/dc19-S012.

    PubMed 30559238

  • Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.

    PubMed 30415602

  • Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.

    PubMed 30990260

  • Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.

    PubMed 28605608

  • Pham SV, Chilton RJ. EMPA-REG OUTCOME: The Cardiologist's Point of View. Am J Cardiol. 2017 Jul 1;120(1S):S53-S58. doi: 10.1016/j.amjcard.2017.05.011. Epub 2017 May 30.

    PubMed 28606345

  • Cahn A, Mosenzon O, Wiviott SD, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE-TIMI 58 Study. Diabetes Care. 2020 Feb;43(2):468-475. doi: 10.2337/dc19-1476. Epub 2019 Dec 16.

    PubMed 31843945

Questions about this trial

What is this clinical trial studying?

An observational study of Type2Diabetes, run by University of Milan at 1 site in Italy.

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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. 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 Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elio Ippolito, MS (0239042648, elio.ippolito@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation in HbA1c values (% -point) (time frame: From Baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05477017, 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 28 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in