Type2Diabetes
Conditions
Keywords
SGLT2-inhibitors, Elderly, Safety
Brief 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. 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
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.
Interventions
DRUGSGLT2 inhibitor
Selective inhibitors of the sodium and glucose co-transporter 2 (SGLT2) originated as antidiabetic drugs thanks to their hypoglycemic and glycosuric effect.
Sponsors
University of Milan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation in HbA1c values (% -point) | From Baseline to 12 months | Variation in HbA1c values (% -point) from baseline to 12 months from enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of fasting glycemic control | From Baseline to 12 months | Evaluation of fasting glycemic control (mg/dl) |
| Evaluation of the weight | From Baseline to 12 months | Evaluation of the weight (Kg) |
| Evaluation of the BMI | From Baseline to 12 months | Evaluation of the BMI (Kg/m2) |
| Evaluation of the waist circumference | From Baseline to 12 months | Evaluation of the waist circumference (cm) |
| Evaluation of the maintenance of glycemic compensation | From Baseline to 12 months | Evaluation of the maintenance of glycemic compensation after the initiation of glycosuric therapy in clinical practice |
| Evaluation of the heart rate | From Baseline to 12 months | Evaluation of the heart rate (bpm) |
| Evaluation of the serum creatinine | From Baseline to 12 months | Evaluation of the serum creatinine (mg/dl) |
| Evaluation of the e-GFR | From Baseline to 12 months | Evaluation of the e-GFR (mL/min/1.73m2) |
| Evaluation of the main side effects and the withdrawal rate | 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 |
| Evaluation of the systolic and diastolic pressure | From Baseline to 12 months | Evaluation of the systolic and diastolic pressure (mmHg) |
Countries
Italy
Contacts
Primary ContactElio Ippolito, MS
Backup ContactMariaElena Lunati, MD
Outcome results
None listed