Durability of Combination of Insulin and GLP-1 Receptor Agonist or SGLT-2 Inhibitors Versus Basal Bolus Insulin Regimen in Type 2 Diabetes (BEYOND)
- Conditions
- Type 2 Diabetes
- Interventions
- Drug: Insulin/CanaglifozinDrug: Basal BolusDrug: Insulin/DapaglifozinDrug: Insulin/Empaglifozin
- Registration Number
- NCT04196231
- Lead Sponsor
- University of Campania "Luigi Vanvitelli"
- Brief Summary
BEYOND represents an open-label, parallel, three-arm randomized controlled trial, aimed at evaluating the effects of combination therapy of fixed ratio basal insulin/GLP-1 receptor agonist (GLP-1RA) or basal insulin/SGLT-2 inhibitors (SGLT-2i) on the durability of the glycemic control, as compared with the basal bolus insulin regimen, in people with type 2 diabetes failing to achieve glycemic targets with injective therapy. The potential benefits for participants in the study include the possibility of improving the glyco-metabolic control with drugs that have been evaluated as safe and protective for the heart and the kidneys. The primary outcome of the study is the mean HbA1c change between groups at six months. Participants in the study will be followed for subsequent 18 months in order to evaluate the durability of glycemic control and the chenge of other secondary outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 258
- Poor glycemic control (HbA1c ≥7.5%)
- Stable basal bolus insulin regimen for almost a year, eventually associated with metformin.
- Type 1 diabetes or secondary diabetes;
- Previous treatment for the last three months with GLP-1RA or DPP-4 inhibitors;
- Hypersensitivity towards active substances or other ingredients of the drugs used in the study
- Participation in other trial with experimental drugs within 30 days
- Diseases that represent contraindication to GLP-1RA use (pancreatitis, gallstones)
- Pregnancy or planned pregnancy within the time of the study
- Serum creatinine > 1,3 mg/dL in women and >1,4 mg/dL in men
- eGFR < 30 mL/min
- Previous cancer or antineoplastic therapy for five years before randomization
- Current therapy with glucocorticoid (oral, topic or sistemic administration) or with antypsichotic drugs
- Previous ketoacidosis
- Any clinical, psychologic or psychiatric condition that is incompatible with the study according to the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin/SGLT-2i Insulin/Canaglifozin Patients in this arm will receive the basal insulin used before the randomization and one of these SGLT-2i according to the current clinical practice and the drugs' data sheet: canagliflozin, dapagliflozin or empagliflozin. Insulin/SGLT-2i Insulin/Dapaglifozin Patients in this arm will receive the basal insulin used before the randomization and one of these SGLT-2i according to the current clinical practice and the drugs' data sheet: canagliflozin, dapagliflozin or empagliflozin. Insulin/SGLT-2i Insulin/Empaglifozin Patients in this arm will receive the basal insulin used before the randomization and one of these SGLT-2i according to the current clinical practice and the drugs' data sheet: canagliflozin, dapagliflozin or empagliflozin. Basal Bolus Basal Bolus Patients in this arm will receive a basal insulin (glargine, glargine-300 or degludec) at bed-time plus 3 injections of a short-acting insulin analogue (aspart, lispro or glulisine) before meals FR insulin/GLP-1RA IGlarLixi Patients in this arm will receive one of these fixed ratio combo of insulin and GLP-1RAs, according to the current clinical practice and the drugs' data sheet: IDegLira or IGlarLixi FR insulin/GLP-1RA IDegLira Patients in this arm will receive one of these fixed ratio combo of insulin and GLP-1RAs, according to the current clinical practice and the drugs' data sheet: IDegLira or IGlarLixi
- Primary Outcome Measures
Name Time Method Hba1c change 6 months, 9 months, 12 months HbA1c group difference at 6 months
Proportions of patients with significant HbA1c change Baseline, 3 months, 6 months, 9 months, 12 months, 18 months Proportions of patients undergoing a reduction equal or higher than 0.5% as compared with baseline levels during the follow up
- Secondary Outcome Measures
Name Time Method Change in total daily insulin dose Baseline, 6 months, 18 months Weight Change Baseline, 6 months, 18 months BMI Change Baseline, 6 months, 18 months Waist circumference change Baseline, 6 months, 18 months Blood pressure change Baseline, 6 months, 18 months Fasting glycemia change Baseline, 6 months, 18 months Post-prandial glycemia change Baseline, 6 months, 18 months C-peptide change Baseline, 6 months, 18 months Change in lipide profile Baseline, 6 months, 18 months Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Change in eGFR Baseline, 6 months, 18 months Diabetes treatment satisfaction Baseline, 6 months, 18 months In order to measure satisfaction with diabetes treatment regimens, we used the self-reported Diabetes Treatment Satisfaction Questionnaire. This instrument aims to assess levels of satisfaction in subjects using different treatment strategies. The questionnaire consists of eight questions: six questions addresses general satisfaction with a score from 0 to 6 for each question (0 = worst), that has to be computed in a total score ranging from 0 (=worst) to 36 (=best); among the remaining two questions, which has to be computed separately as two subscales, one concerns the perception of hyperglycemic events and another the perception of hypoglycemic events, both with a score from 0 (none of the time) to 6 (most of the time).
Trial Locations
- Locations (1)
Unit of Endocrinology and Metabolic Diseases
🇮🇹Naples, Italy