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Synthetic Amylin Analog

Pramlintide + Insulin with Artificial Pancreas for Type 1 Diabetes

N/A
Recruiting
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject needs to take any medications that are contraindicated in the study
Clinical diagnosis of type 1 diabetes for at least 12 months (diagnosis based on clinical judgment)
Must not have
Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
Unable to travel to research center within 3h if needed during study interventions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks

Summary

This trial is testing whether adding pramlintide, a synthetic analog of the hormone amylin, to a closed-loop system will better normalize glucose levels in adults with Type 1 Diabetes, especially during the post-prandial period.

Who is the study for?
Adults over 18 with Type 1 Diabetes using an insulin pump and practicing carbohydrate counting can join. They must not be pregnant, planning pregnancy, or breastfeeding, and agree to use effective birth control if applicable. Excluded are those on certain diabetes medications, have had severe hypoglycemia or ketoacidosis recently, take drugs affecting stomach emptying or glucocorticoids (except low stable doses), have gastroparesis, major heart events in the last 6 months, or serious illnesses.
What is being tested?
The trial tests a dual-hormone artificial pancreas system that delivers both pramlintide and rapid-acting insulin based on glucose levels to improve blood sugar control after meals in adults with Type 1 Diabetes. It aims to see if this approach is better than current methods at normalizing glucose especially post-meal.
What are the potential side effects?
Possible side effects include low blood sugar episodes (hypoglycemia), delayed stomach emptying which could affect digestion timing, potential allergic reactions to the synthetic hormone analog pramlintide or other study drug components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on any medications that the study does not allow.
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I have been diagnosed with type 1 diabetes for over a year.
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I have been using an insulin pump for over 6 months and count my carbs.
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I have had severe low blood sugar episodes that needed hospital care or help to manage.
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I have been diagnosed with type 1 diabetes for over a year.
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I no longer wish to participate in the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a heart attack or heart surgery in the last 6 months.
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I can travel to the research center within 3 hours if needed.
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My daily medication dose is less than 0.4 units per kg of my body weight.
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I have had a severe low blood sugar episode in the last 3 months.
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I have been diagnosed with gastroparesis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time in target range
Secondary study objectives
Gastrointestinal symptoms
Mean glucose level
Number of hypoglycemia events
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rapid Insulin-Plus-PramlintideExperimental Treatment3 Interventions
Rapid insulin and pramlintide infusion in two insulin pumps
Group II: Rapid Insulin-Plus-PlaceboPlacebo Group3 Interventions
Rapid insulin and placebo (saline) infusion in two insulin pumps
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rapid-Acting Insulin
2021
Completed Phase 4
~90
Pramlintide Acetate
2020
N/A
~40
Artificial Pancreas
2020
N/A
~270

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,386 Previous Clinical Trials
26,515,949 Total Patients Enrolled
25 Trials studying Diabetes
2,228 Patients Enrolled for Diabetes
McGill UniversityLead Sponsor
408 Previous Clinical Trials
1,018,382 Total Patients Enrolled
2 Trials studying Diabetes
95 Patients Enrolled for Diabetes

Media Library

Pramlintide Acetate (Synthetic Amylin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04243629 — N/A
Diabetes Research Study Groups: Rapid Insulin-Plus-Placebo, Rapid Insulin-Plus-Pramlintide
Diabetes Clinical Trial 2023: Pramlintide Acetate Highlights & Side Effects. Trial Name: NCT04243629 — N/A
Pramlintide Acetate (Synthetic Amylin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04243629 — N/A
Diabetes Patient Testimony for trial: Trial Name: NCT04243629 — N/A
~6 spots leftby Nov 2025
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