A Randomized Clinical Trial Comparing Semaglutide GLP1 Agonists With Degludec Basal-bolus Insulin in Early Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- change in HA1c and mounts of insulin of basal and bolus which will be taken daily is the same or decreased after one year of follow up
研究概览
简要总结
type 1 diabetes is an autoimmune disease and still, some unknown mechanisms are undiscovered millions of children and adults suffer from this type which need basal-bolus insulin as the classical regimen, and basal-bolus insulin is the best type of treatment is similar to the physiological pattern, so our target and may studies before how to preserve the residual beta cells or postpone the complete destruction or extend the honeymoon stage to improve quality of life, the most challenge at type 1 diabetes is diabetic ketoacidosis which affect the quality of life and risk of death so at our clinical trials using the combination of basal insulin-like degludec as its action extend to 72 hours and has high flexibility and less hypoglycemic events and has an affinity to 99% to albumin so may be considered the most type of insulin is similar to human physiological insulin as 50% of insulin pass through portal circulation so no insulin until now it is mimic the normal physiological insulin but IDeg is the nearest to normal until now, Objective: To compare the efficacy and safety of basal-bolus insulin degludec and semaglutide with regular standard of care versus basal-bolus insulin with regular standard of care in early type 1 diabetic patients.
In our study, the investigators will compare 2 groups of early type 1 patients in the age group 18 years to 35 years Protocol and Methodology for a Randomized Controlled Trial of Basal-Bolus Insulin Degludec and Semaglutide with Regular Standard of Care Versus Basal-Bolus Insulin with Regular Standard of Care in Early Type 1 Diabetic Patients
Study Design: Randomized, controlled, open-label trial
Setting: Outpatient diabetes clinics
Participants: Early type 1 diabetic patients (aged 18-35 years) who have been diagnosed with type 1 diabetes for less than 2 years and have a hemoglobin A1c (HbA1c) of 7.0-11%.
the tests will be done pre- and post :
- Anti GAD 65 and anti IA2
- HA1C
- Serum C peptide
- fasting insulin
- serum zinc
详细描述
type 1 diabetes is an autoimmune disease and still, some unknown mechanisms are undiscovered millions of children and adults suffer from this type which need basal-bolus insulin as the classical regimen, and basal-bolus insulin is the best type of treatment is similar to the physiological pattern, so our target and may studies before how to preserve the residual beta cells or postpone the complete destruction or extend the honeymoon stage to improve quality of life, the most challenge at type 1 diabetes is diabetic ketoacidosis which affect the quality of life and risk of death so at our clinical trials using the combination of basal insulin-like degludec as its action extend to 72 hours and has high flexibility and less hypoglycemic events and has an affinity to 99% to albumin so may be considered the most type of insulin is similar to human physiological insulin as 50% of insulin pass through portal circulation one of the amazing advantages of IDeg is that no accumulation After 2-3 days of once-daily dosing, IDeg concentrations reach a steady state with no additional accumulation since, at that time, the daily-injected dose equals the daily-eliminated quantity of insulin when repeated equivalent doses are delivered at sufficient intervals.
the tests will be done pre- and post :
- Anti GAD 65 and anti IA2
- HA1C
- Serum C peptide
- fasting insulin
- serum zinc
Insulin-bound insulin :
one other advantage of IDeg is insulin-bound insulin so no difference in clearance at renal or liver-impaired patients and normal functions. Albumin-bound insulins are not as easily filtered by the kidney as unbound insulins. Thus, hepatic and renal impairment have no effect on the PK characteristics of these insulin mimics.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •early diagnosed type 1 diabetic patients were diagnosed in the last 6 months age of two groups: from 18-35 years basal-bolus insulin patients
排除标准
- •no oral hypoglycemic drugs no pregnancy no hypoglycemic drugs or immunosuppressant no history of diabetic ketoacidosis
研究组 & 干预措施
60 early type 1 diabetes with semaglutide and degludec basal bolus insulin
degludec administered once daily bolus insulin three times daily and time in range and Semaglutide once weekly
干预措施: Semaglutide weekly injection (Drug)
结局指标
主要结局
change in HA1c and mounts of insulin of basal and bolus which will be taken daily is the same or decreased after one year of follow up
时间窗: Time Frame: one year
change in A1C and daily insulin requirements will be reduced at the end of one year from study was started
次要结局
- the change in weight after follow up of one year(one year)
研究者
Amr kamel khalil Ahmed
public health department, MSc, Riaydh first health cluster, Ministry of health , Saudia arabia
Ministry of Health, Saudi Arabia