Clinical trial NCT05477017: Evaluation of SGLT2-i Effectivness and Safety in Elderly Type 2 Diabetes Patients
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type2Diabetes
Keywords: SGLT2-inhibitors
Elderly
Safety
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 800
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly with type 2 diabetes receiving SGLT2-i therapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation in HbA1c values (% -point)
timeFrame: From Baseline to 12 months
Secondary outcomes:
measure: Evaluation of the maintenance of glycemic compensation
timeFrame: From Baseline to 12 months
measure: Evaluation of fasting glycemic control
timeFrame: From Baseline to 12 months
measure: Evaluation of the weight
timeFrame: From Baseline to 12 months
measure: Evaluation of the BMI
timeFrame: From Baseline to 12 months
measure: Evaluation of the waist circumference
timeFrame: From Baseline to 12 months
measure: Evaluation of the systolic and diastolic pressure
timeFrame: From Baseline to 12 months
measure: Evaluation of the heart rate
timeFrame: From Baseline to 12 months
measure: Evaluation of the serum creatinine
timeFrame: From Baseline to 12 months
measure: Evaluation of the e-GFR
timeFrame: From Baseline to 12 months
measure: Evaluation of the main side effects and the withdrawal rate
timeFrame: From Baseline to 12 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ASST FBF Sacco
Study officials:
affiliation: ASST FBF-Sacco
name: Paolo Fiorina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.