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UnknownPhase NA

Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes

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.

Lead sponsor

McGill University

Asset

Pramlintide

Amylin analog

Listed sites

1

Recruiting sites

1

Enrollment

26

estimated

Study population

Type 1 diabetes

Key I/E criterion

HbA1c ≤11%

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 IDNCT04243629
Org study ID2020-6258

Timeline

Milestones

Study first posted2020-01-28actual
Study start2021-11-12actual
Last update posted2023-03-15actual
Primary completion2024-04estimated (month precision)
Study completion2024-04estimated (month precision)

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. Signed and dated written informed consent

2. Males and females ≥ 18 years of age

3. HbA1c ≤ 11% (this is so we also include patient that are potentially missing some meal boluses)

4. Insulin pump use for at least 6 months and actively performing carbohydrate counting

5. Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of T1D is based on the investigator's clinical judgment; C peptide level and antibody determinations are not planned.

6. Women of child-bearing potential must be ready and able to use a highly effective method of birth control. Women of childbearing potential are females who have experienced [the first occurrence of menstruation] and do not meet the criteria for women not of childbearing potential. Women not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

Exclusion criteria

1. Current total daily dose < 0.4 units/kg (we wish to exclude participants who would still be considered in honeymoon period).

2. Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2 inhibitors, GLP-1 agonists, Metformin, Acarbose, etc.…).

3. Current use of glucocorticoid medication (except low stable dose and inhaled steroids).

4. Anticipated need to use acetaminophen during study participation

5. Use of medication that alters gastrointestinal motility.

6. Planned or ongoing pregnancy.

7. Breastfeeding individuals.

8. Severe hypoglycemic episode within 3 months of admission.

9. Severe diabetes ketoacidosis episode within 3 months of admission.

10. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.

11. Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.

12. Known hypersensitivity to any of the study drugs or their excipients.

13. Individuals with confirmed gastroparesis.

14. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

15. In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study devices.

16. Unable to travel to research center within 3h if needed during study interventions

17. Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Discontinuation Criteria:

1. Failure to comply with the protocol.

2. Pregnancy.

3. After an event which the PI believes it is not in the best interest for the patient to continue the trial.

4. The subject wants to withdraw consent to participate

5. The subject needs to take any medications that are contraindicated in the study

6. The subject can no longer be treated with the study medication for other reasons

7. The subject experiences severe hypoglycaemia requiring hospitalization or repeated hypoglycaemia requiring assistance to treat.

8. The subject fails to follow instructions given about the trial

9. The Study Team has decided to discontinue or terminate the clinical trial prematurely

Endpoints (9)

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
6
Safety / tolerability / PK
2
Other (unclassified)
1

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

Time in target range

Time frame:4 weeks

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Time between 3.9 - 7.8 mmol/L

Time frame:4 weeks

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

Time below 3,9, 3.3, and 2.8 mmol/L

Time frame:4 weeks

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

Time above 7.8, 10.0, 13.9, 16.7 mmol/L

Time frame:4 weeks

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Mean glucose level

Time frame:4 weeks

descriptive

Secondary/protocol endpoint/low confidence

Standard deviation and coefficient of variance

Time frame:4 weeks

descriptive

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Gastrointestinal symptoms

Time frame:4 weeks

event count, event

Secondary/protocol endpoint

Number of hypoglycemia events

Time frame:4 weeks

Documented hypoglycemia

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Total insulin delivery

Time frame:4 weeks

descriptive

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.