Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06057077 |
| Other study ID # |
Amr Ahmed, Maher M.Akl |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Ministry of Health, Saudi Arabia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 7.0-11%.
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
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 7.0-11%.
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 0.5% in HbA1c between the two arms with a power of 80% and a significance level
of 0.05.
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 study's 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.
