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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Hba1c change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Poor glycemic control (HbA1c ≥7.5%)
- •Stable basal bolus insulin regimen for almost a year, eventually associated with metformin.
排除标准
- •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
研究组 & 干预措施
FR insulin/GLP-1RA
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
干预措施: IDegLira (Drug)
FR insulin/GLP-1RA
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
干预措施: IGlarLixi (Drug)
Insulin/SGLT-2i
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.
干预措施: Insulin/Canaglifozin (Drug)
Insulin/SGLT-2i
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.
干预措施: Insulin/Dapaglifozin (Drug)
Insulin/SGLT-2i
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.
干预措施: Insulin/Empaglifozin (Drug)
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
干预措施: Basal Bolus (Drug)
结局指标
主要结局
Hba1c change
时间窗: 6 months, 9 months, 12 months
HbA1c group difference at 6 months
Proportions of patients with significant HbA1c change
时间窗: 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
次要结局
- 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)
- Change in eGFR(Baseline, 6 months, 18 months)
- Diabetes treatment satisfaction(Baseline, 6 months, 18 months)
研究者
Katherine Esposito
Full Professor of Endocrinology and Metabolic Diseases
University of Campania "Luigi Vanvitelli"