Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06057077
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-09-15
Brief Title:
Semaglutide GLP1 Agonists With Degludec Basal-bolus Insulin in Early Type 1 Diabetes to Basal-bolus
Sponsor:
Ministry of Health Saudi Arabia
Organization:
Ministry of Health Saudi Arabia
Study Overview
Official Title:
A Randomized Clinical Trial Comparing Semaglutide GLP1 Agonists With Degludec Basal-bolus Insulin in Early Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 70-11
the tests will be done pre- and post
1 Anti GAD 65 and anti IA2
2 HA1C
3 Serum C peptide
4 fasting insulin
5 serum zinc
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 70-11
the tests will be done pre- and post
1 Anti GAD 65 and anti IA2
2 HA1C
3 Serum C peptide
4 fasting insulin
5 serum zinc
Detailed Description:
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
1 Anti GAD 65 and anti IA2
2 HA1C
3 Serum C peptide
4 fasting insulin
5 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
synergism between semaglutide as GLP1 agonist and ultralong acting insulin like IDeg is suspected to give more benefits to early type 1 diabetes like extending the honeymoon phase and may preserve the residual beta cells function also may affect autoantibodies like anti-GAD65 and anti islets cells 2 anri IA2 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
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
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 70-11
Exclusion Criteria
Pregnancy or breastfeeding History of severe hypoglycemia History of diabetic ketoacidosis History of pancreatitis History of hypersensitivity to insulin degludec or semaglutide Use of any other antidiabetic medications other than basal-bolus insulin
Interventions
Arm 1 Basal-bolus insulin degludec and semaglutide with regular standard of care Arm 2 Basal-bolus insulin with the regular standard of care
Regular standard of care
Diabetes self-management education Nutritional counseling Physical activity counseling Self-monitoring of blood glucose SMBG Insulin dose adjustment Basal-bolus insulin degludec Administered once daily Dosing adjusted based on SMBG results Semaglutide Administered once weekly dosing adjusted based on SMBG results
Outcomes
Primary outcome Change in HbA1c from baseline to 24 weeks
Secondary outcomes
Change in body weight from baseline to 24 weeks Frequency of hypoglycemia episodes from baseline to 24 weeks Time in range TIR from baseline to 24 weeks Quality of life from baseline to 24 weeks
Sample Size
A sample size of 120 participants 60 per arm is estimated to be sufficient to detect a difference of 05 in HbA1c between the two arms with a power of 80 and a significance level of 005
Randomization
Participants will be randomized to one of the two arms using a computer-generated random number table
Blinding
The study is open-label meaning that participants and investigators will be aware of which treatment arm they are in
Follow-up
Participants will be followed for 24 weeks They will be required to attend clinic visits every 6 weeks for assessments of HbA1c body weight and frequency of hypoglycemia episodes They will also be required to wear a continuous glucose monitor CGM for 1 week at baseline and at 24 weeks to assess TIR
Data Analysis
Data will be analyzed using SPSS software The primary outcome will be analyzed using an unpaired t-test Secondary outcomes will be analyzed using appropriate statistical tests such as chi-squared tests and ANOVA
Safety
All participants will be monitored closely for any adverse events Any adverse events will be reported to the studys safety monitoring committee
Ethical Considerations
The study will be conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice Guidelines The study protocol will be reviewed and approved by an institutional review board
Informed Consent
All participants will be required to provide written informed consent before participating in the study
Discussion
This randomized controlled trial will compare the efficacy and safety of basal-bolus insulin degludec and semaglutide with the regular standard of care versus basal-bolus insulin with the regular standard of care in early type 1 diabetic patients The results of this study will provide valuable information about the best treatment options for this population
the tests will be done pre- and post
1 Anti GAD 65 and anti IA2
2 HA1C
3 Serum C peptide
4 fasting insulin
5 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
synergism between semaglutide as GLP1 agonist and ultralong acting insulin like IDeg is suspected to give more benefits to early type 1 diabetes like extending the honeymoon phase and may preserve the residual beta cells function also may affect autoantibodies like anti-GAD65 and anti islets cells 2 anri IA2 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
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
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 70-11
Exclusion Criteria
Pregnancy or breastfeeding History of severe hypoglycemia History of diabetic ketoacidosis History of pancreatitis History of hypersensitivity to insulin degludec or semaglutide Use of any other antidiabetic medications other than basal-bolus insulin
Interventions
Arm 1 Basal-bolus insulin degludec and semaglutide with regular standard of care Arm 2 Basal-bolus insulin with the regular standard of care
Regular standard of care
Diabetes self-management education Nutritional counseling Physical activity counseling Self-monitoring of blood glucose SMBG Insulin dose adjustment Basal-bolus insulin degludec Administered once daily Dosing adjusted based on SMBG results Semaglutide Administered once weekly dosing adjusted based on SMBG results
Outcomes
Primary outcome Change in HbA1c from baseline to 24 weeks
Secondary outcomes
Change in body weight from baseline to 24 weeks Frequency of hypoglycemia episodes from baseline to 24 weeks Time in range TIR from baseline to 24 weeks Quality of life from baseline to 24 weeks
Sample Size
A sample size of 120 participants 60 per arm is estimated to be sufficient to detect a difference of 05 in HbA1c between the two arms with a power of 80 and a significance level of 005
Randomization
Participants will be randomized to one of the two arms using a computer-generated random number table
Blinding
The study is open-label meaning that participants and investigators will be aware of which treatment arm they are in
Follow-up
Participants will be followed for 24 weeks They will be required to attend clinic visits every 6 weeks for assessments of HbA1c body weight and frequency of hypoglycemia episodes They will also be required to wear a continuous glucose monitor CGM for 1 week at baseline and at 24 weeks to assess TIR
Data Analysis
Data will be analyzed using SPSS software The primary outcome will be analyzed using an unpaired t-test Secondary outcomes will be analyzed using appropriate statistical tests such as chi-squared tests and ANOVA
Safety
All participants will be monitored closely for any adverse events Any adverse events will be reported to the studys safety monitoring committee
Ethical Considerations
The study will be conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice Guidelines The study protocol will be reviewed and approved by an institutional review board
Informed Consent
All participants will be required to provide written informed consent before participating in the study
Discussion
This randomized controlled trial will compare the efficacy and safety of basal-bolus insulin degludec and semaglutide with the regular standard of care versus basal-bolus insulin with the regular standard of care in early type 1 diabetic patients The results of this study will provide valuable information about the best treatment options for this population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None