Evaluation of SGLT2-i Effectivness and Safety in Elderly Type 2 Diabetes Patients (SOLDMiDiab02)

July 25, 2022 updated by: Paolo Fiorina, MD, University of Milan

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20157
        • Asst Fbf Sacco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Elderly with type 2 diabetes receiving SGLT2-i therapy

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in HbA1c values (% -point)
Time Frame: From Baseline to 12 months
Variation in HbA1c values (% -point) from baseline to 12 months from enrollment
From Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the maintenance of glycemic compensation
Time Frame: From Baseline to 12 months
Evaluation of the maintenance of glycemic compensation after the initiation of glycosuric therapy in clinical practice
From Baseline to 12 months
Evaluation of fasting glycemic control
Time Frame: From Baseline to 12 months
Evaluation of fasting glycemic control (mg/dl)
From Baseline to 12 months
Evaluation of the weight
Time Frame: From Baseline to 12 months
Evaluation of the weight (Kg)
From Baseline to 12 months
Evaluation of the BMI
Time Frame: From Baseline to 12 months
Evaluation of the BMI (Kg/m2)
From Baseline to 12 months
Evaluation of the waist circumference
Time Frame: From Baseline to 12 months
Evaluation of the waist circumference (cm)
From Baseline to 12 months
Evaluation of the systolic and diastolic pressure
Time Frame: From Baseline to 12 months
Evaluation of the systolic and diastolic pressure (mmHg)
From Baseline to 12 months
Evaluation of the heart rate
Time Frame: From Baseline to 12 months
Evaluation of the heart rate (bpm)
From Baseline to 12 months
Evaluation of the serum creatinine
Time Frame: From Baseline to 12 months
Evaluation of the serum creatinine (mg/dl)
From Baseline to 12 months
Evaluation of the e-GFR
Time Frame: From Baseline to 12 months
Evaluation of the e-GFR (mL/min/1.73m2)
From Baseline to 12 months
Evaluation of the main side effects and the withdrawal rate
Time Frame: From Baseline to 12 months
Evaluation of the main side effects and the withdrawal ratein the first year of treatment. It will be evalueted through scheduled clinical visit
From Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Principal Investigator: Paolo Fiorina, MD, ASST FBF-Sacco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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