Durability of combination of insulin and GLP-1 receptor agonist or SGLT-2 inhibitors versus basal bolus insulin regimen in type 2 diabetes: a randomized controlled trial

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-002977-69-IT
• Lead Sponsor: A.O.U. Università degli Studi della Campania Luigi Vanvitelli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients on insulin therapy basal bolus stable for at least one year associated or not with metformin
• Insufficient glycemic control (HbA1c> 7.5%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

• Type 1 diabetes or diabetes secondary to specific causes
• Previous treatment (within the last 3 months) with a GLP-1RA or a DPPIV inhibitor
• Contraindications to the use of GLP-1RA (pancreatitis, gallbladder stones)
• Pregnancy or pregnancy scheduled during the study period
• Serum creatinine> 1.3 mg / dL in women and> 1.4 mg / dL in men
• GFR <30 ml / min
• History of cancer or anti-neoplastic therapy in the 5 years prior to randomization
• Current therapy with oral, topical or systemic glucocorticoids, or with atypical anti-psychotics.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified