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Dual

CompletedPhase 2

Insulin-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

McGill University

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

NCT IDNCT03800875
Org study IDTriple Hormone

Timeline

Milestones

Study first posted2019-01-11actual
Study start2019-02-08actual
Primary completion2020-09-19actual
Study completion2020-09-19actual
Last update posted2021-06-08actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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
Safety / tolerability / PK
5
Other (unclassified)
1

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

Total 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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Mean sensor glucose concentration during the overnight stay

Time frame:8 hours

concentration, improvement

Secondary/protocol endpoint

Mean glucose level

Time frame:24-hour period

descriptive, improvement

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Number 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

Secondary/protocol endpoint

The number and severity of gastrointestinal sysmptoms experienced by a participant

Time frame:27 hours

descriptive

Secondary/protocol endpoint

Mean daytime insulin concentration

Time frame:14 hours

concentration, descriptive

Secondary/protocol endpoint

Mean daytime concentration of amylin

Time frame:14 hours

concentration, descriptive

Secondary/protocol endpoint

Total amount of pramlintide delivered to the participant

Time frame:24 hours

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Total 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.