← Trials/Trial dossier/NCT03800875
Dual
CompletedPhase 2Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting
A Randomized, Controlled, Crossover Trial to Assess a Dual-hormone (Insulin-pramlintide) Closed-loop Delivery Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes
Lead sponsor
Asset
Pramlintide
Amylin analog
Listed sites
1
Recruiting sites
—
Enrollment
24
actual
Study population
Type 1 diabetes
Key I/E criterion
•HbA1c ≤12%
Primary endpoint
•CGM time-in-range
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Males and females ≥ 18 years of age.
2. Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
3. Insulin pump therapy for at least 6 months.
4. HbA1c ≤ 12% in the last 6 months.
Exclusion criteria
1. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc.…).
2. Severe hypoglycemic episode within one month of admission.
3. Severe diabetic ketoacidosis episode within one month of admission.
4. Pregnancy.
5. Known or suspected allergy to the study drugs.
6. Gastroparesis.
7. Use of prokinetic drugs that stimulate gastric emptying (domperidone, cisapride, metoclopramide).
8. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
9. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
10. Current use of glucocorticoid medication.
11. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
12. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
Endpoints (11)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
5 endpointsTotal percentage of time (22:00-22:00) that the glucose concentration remained within 3.9 and 10.0 mmol/L
Time frame:24 hours
CGM time-in-range
descriptive, improvement
Total percentage of time (22:00-22:00) that the glucose concentration remained within specified ranges.
Time frame:24 hours
CGM time-in-range
descriptive, improvement
Percentage of overnight time (24:00-8:00) that the glucose concentration remained within specified ranges.
Time frame:8 hours
CGM time-in-range
descriptive, improvement
Mean sensor glucose concentration during the overnight stay
Time frame:8 hours
concentration, improvement
Mean glucose level
Time frame:24-hour period
descriptive, improvement
Safety / tolerability / PK
5 endpointsNumber of participants experiencing hypoglycemia requiring oral treatment during: a. the overall study period; b. the night; c. the day
Time frame:27 hours
Documented hypoglycemia
event count, event
The number and severity of gastrointestinal sysmptoms experienced by a participant
Time frame:27 hours
descriptive
Mean daytime insulin concentration
Time frame:14 hours
concentration, descriptive
Mean daytime concentration of amylin
Time frame:14 hours
concentration, descriptive
Total amount of pramlintide delivered to the participant
Time frame:24 hours
descriptive
Other (unclassified)
1 endpointTotal amount of insulin delivered to the participant
Time frame:24 hours
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The Lancet. Digital health2021 Nov (month)PMID34580055doi:10.1016/S2589-7500(21)00139-4via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.