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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2 inhibitor | Drug | Selective inhibitors of the sodium and glucose co-transporter 2 (SGLT2) originated as antidiabetic drugs thanks to their hypoglycemic and glycosuric effect. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Elderly with type 2 diabetes receiving SGLT2-i therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elio Ippolito, MS | Contact | 0239042648 | elio.ippolito@unimi.it | |
| MariaElena Lunati, MD | Contact | mariaelena.lunati@asst-fbf-sacco.it |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Fiorina, MD | ASST FBF-Sacco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST FBF Sacco | Milan | 20157 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30559238 | Result | 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. | |
| 30415602 | Result | 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. |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| C570240 | empagliflozin |
| C529054 | dapagliflozin |
| D000068896 | Canagliflozin |
| C570288 | ertugliflozin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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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 |
| 30990260 | Result | 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. |
| 28605608 | Result | 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. |
| 28606345 | Result | 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. |
| 31843945 | Result | 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. |
| D045505 | Physiological Effects of Drugs |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |