Last reviewed · How we verify
NCT04243629
Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System to Regulate Glucose Levels in Adults Living With Type 1 Diabetes: a Randomized, Controlled, Crossover Trial.
NA trial testing Rapid-Acting Insulin in Diabetes Mellitus, Type 1 in 26 participants. Status unknown.
1 April 2024
Quick facts
| Lead sponsor | McGill University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 12 November 2021 |
| Primary completion | 1 April 2024 |
| Estimated completion | 1 April 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Rapid-Acting Insulin — full drug profile →
- Placebo
- Pramlintide Acetate — full drug profile →
- Artificial Pancreas
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
- Postprandial Hyperglycemia — all drugs for Postprandial Hyperglycemia →
Sponsor
McGill University
Who can join
18 and older, any sex, with Diabetes Mellitus, Type 1 or Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Time in target range
Time frame: 4 weeks
Time each participant spent with glucose level in target range (3.9 - 10.0 mmol/L)
Sponsor's own description
One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times. Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes. Amylin, in the postprandial period, contributes to regulating glucose levels by delaying gastric emptying, suppressing nutrient-stimulated glucagon secretion, and increasing satiety. Pramlintide is a synthetic analog of the hormone amylin. A closed-loop system that delivers both insulin and pramlintide, based on glucose sensor readings, has the potential to better normalize glucose levels, especially during the post-prandial period. The aim of this project is to assess whether co-administration of pramlintide with rapid insulin in an artificial pancreas system will improve glycemic control in adults with Type 1 Diabetes.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Advancing Type 1 Diabetes Management: Integrating Novel Therapies, Technologies, and Adjunctive Approaches.
Snaith JR, Narongkiatikhun P, Bjornstad P, Greenfield JR, et al · · 2026 · PMID 40880508 · DOI 10.2337/dci25-0015
Verify or expand the search:
- PubMed search for NCT04243629
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rapid-Acting Insulin
Trials testing the same drug.
- NCT05136157 — Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control · EARLY_PHASE1 · completed
- NCT04157738 — A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus · Phase 4 · completed
Other recruiting trials for Diabetes Mellitus, Type 1
Currently open trials in the same condition.
- NCT07325461 — Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes · NA · recruiting
- NCT07305805 — A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Phase 1 · recruiting
- NCT06282055 — Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes · recruiting
- NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
- NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting
Other McGill University trials
Trials by the same sponsor.
- NCT07178535 — Feasibility of Real-Time Visual Feedback in Augmented Reality to Reduce Gait Asymmetry Post-Stroke · NA · not yet recruiting
- NCT07445841 — Protecting the Brain From Post-Stroke Cognitive Impairment and Dementia With Multimodal Exercise Training · NA · recruiting
- NCT07447830 — The Pain Reduction Using Immersive Virtual Reality During Wound Care Evaluation Study at Maimonides (PRISM) - Pilot Stud · NA · recruiting
- NCT06994559 — Music as an Adjunct to Ketamine Therapy for Chronic Pain · NA · recruiting
- NCT07497425 — Neuroimmune Responses to Exercise in Chronic Back Pain · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04243629 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 21 May 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McGill University
- Last refreshed: 14 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04243629.