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

NCT05477017 | Unknown DMC FDA Drug

• 1 other identifier: 03/2022
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2Diabetes

Keywords

SGLT2-inhibitors; Elderly; Safety

Outcome Measures

Primary Outcomes (1)

• Variation in HbA1c values (% -point)

  Variation in HbA1c values (% -point) from baseline to 12 months from enrollment

  From Baseline to 12 months

Secondary Outcomes (10)

• Evaluation of the maintenance of glycemic compensation

  From Baseline to 12 months

• Evaluation of fasting glycemic control

  From Baseline to 12 months

• Evaluation of the weight

  From Baseline to 12 months

• Evaluation of the BMI

  From Baseline to 12 months

• Evaluation of the waist circumference

  From Baseline to 12 months

Interventions

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.

Also known as: Jardiance, Synjardy, Forxiga, Xigduo, Invokana, Vokanamet, Steglatro, Segluromet

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly with type 2 diabetes receiving SGLT2-i therapy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST FBF Sacco

Milan, 20157, Italy

Location

Related Publications (6)

• 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.

  PMID: 30559238 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.

  PMID: 30415602 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.

  PMID: 30990260 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.

  PMID: 28605608 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.

  PMID: 28606345 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.

  PMID: 31843945 RESULT

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors; empagliflozin; dapagliflozin; Canagliflozin; ertugliflozin

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Paolo Fiorina, MD

  ASST FBF-Sacco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elio Ippolito, MS

CONTACT

0239042648; elio.ippolito@unimi.it

MariaElena Lunati, MD

CONTACT

mariaelena.lunati@asst-fbf-sacco.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: July 28, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)