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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Type2Diabetes

Intervention / Treatment
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* Drug: SGLT2 inhibitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SGLT2 inhibitor|Selective inhibitors of the sodium and glucose co-transporter 2 (SGLT2) originated as antidiabetic drugs thanks to their hypoglycemic and glycosuric effect.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in HbA1c values (% -point) | 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 | 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 | Evaluation of fasting glycemic control (mg/dl) | From Baseline to 12 months | 
| Evaluation of the weight | Evaluation of the weight (Kg) | From Baseline to 12 months | 
| Evaluation of the BMI | Evaluation of the BMI (Kg/m2) | From Baseline to 12 months | 
| Evaluation of the waist circumference | Evaluation of the waist circumference (cm) | From Baseline to 12 months | 
| Evaluation of the systolic and diastolic pressure | Evaluation of the systolic and diastolic pressure (mmHg) | From Baseline to 12 months | 
| Evaluation of the heart rate | Evaluation of the heart rate (bpm) | From Baseline to 12 months | 
| Evaluation of the serum creatinine | Evaluation of the serum creatinine (mg/dl) | From Baseline to 12 months | 
| Evaluation of the e-GFR | Evaluation of the e-GFR (mL/min/1.73m2) | From Baseline to 12 months | 
| 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 | From Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SGLT2-inhibitors, Elderly, Safety