Outpatient therapy: 8 weeks of drug therapy with usual treatment + 5 weeks of closed-loop therapy for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Type 1 Diabetes+1 MoreOutpatient therapy: 8 weeks of drug therapy with usual treatment + 5 weeks of closed-loop therapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if semaglutide, a once-weekly injectable medication, can improve glucose control in those with type 1 diabetes when used with a closed-loop insulin system.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: 13 weeks

13 weeks
Average scores between interventions based on quality of life questionnaires
Biochemical analyses (exploratory)
Blood pressure and heart rate
Glucagon, C-peptide, Paracetamol absorption after mixed meal tolerance test (in first 15 participants)
Glycated hemoglobin
Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides
Measured of body mass: weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio
Urine albumin-creatinine ratio
4 weeks
Mean glucose level
Percentage coefficient of variation of glucose levels
Percentage of time of plasma glucose levels spent in target range (semaglutide vs placebo)
Percentage of time spent in the following ranges of glucose levels between 3.9 and 7.8 mmol/L
Percentage of time spent in the following ranges of glucose levels: above 7.8, 10, and 13.9 mmol/L
Percentage of time spent in the following ranges of glucose levels: below 3.9 and 3.0 mmol/L
Proportion of participants with TIR between 3.9 - 10.0 mol/L ≥ 70%
Standard deviation of glucose levels as a measure of glucose variability

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Placebo + closed-loop insulin system
1 of 2
Semaglutide, Ozempic® (at maximum tolerated dose) + closed-loop insulin system
1 of 2

Active Control

Experimental Treatment

28 Total Participants · 2 Treatment Groups

Primary Treatment: Outpatient therapy: 8 weeks of drug therapy with usual treatment + 5 weeks of closed-loop therapy · No Placebo Group · Phase 2 & 3

Semaglutide, Ozempic® (at maximum tolerated dose) + closed-loop insulin system
Drug
Experimental Group · 1 Intervention: Outpatient therapy: 8 weeks of drug therapy with usual treatment + 5 weeks of closed-loop therapy · Intervention Types: Drug
Placebo + closed-loop insulin system
Drug
ActiveComparator Group · 1 Intervention: Outpatient therapy: 8 weeks of drug therapy with usual treatment + 5 weeks of closed-loop therapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 13 weeks

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
399 Previous Clinical Trials
125,494 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are of child-bearing age (if sexually active) and are not using highly effective method of birth control

Who else is applying?

What site did they apply to?
Research Institute of the McGill University Health Centre100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "Hi, I want like to take part of this trial because the heavy condition of type 1 diabetes is what i live day and night from 7 years and to be part of a clinical trial on diabetes is very concerning for me, the everyday pain and frequent unbalances due to my very active life and addiction to sugar make me want to fight, learn more, understand more and help."

How responsive is this trial?

Most responsive sites:
  1. Research Institute of the McGill University Health Centre: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email100.0%