DelfaGLP-1 Atlas

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CompletedPhase 2

Effect of Basal-Bolus Closed-Loop Co-Administration of Insulin and Pramlintide on Improving the Glycemic Control in Type 1 Diabetes

A Randomized, Three-way, Crossover Study to Assess the Efficacy of Fast-acting Insulin-plus-pramlintide Closed-loop Co-administration, Regular Insulin-plus-pramlintide Closed-loop Co-administration, and Fast-acting Insulin-alone Closed-loop Infusion in Regulating Glucose Levels Over a 24-hour Period in Adults With Type 1 Diabetes in Inpatient Settings.

Lead sponsor

McGill University

Asset

Pramlintide

Amylin analog

Listed sites

1

Recruiting sites

—

Enrollment

28

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c ≤10%

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 IDNCT02814123
Org study IDMAP-1

Timeline

Milestones

Study first posted2016-06-27estimated
Study start2017-01-13actual
Primary completion2018-07-08actual
Study completion2018-07-08actual
Last update posted2020-02-17actual

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Males and females ≥ 18 years of age.
•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.)
•The subject will have been on insulin pump therapy for at least 6 months.
•HbA1c ≤ 10%.

Exclusion criteria

•Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc.…).
•Severe hypoglycemic episode within one month of screening.
•Severe diabetes keto-acidosis episode within one month of screening.
•Planned or ongoing pregnancy.
•Known or suspected allergy to the study drugs.
•Gastroparesis.
•Use of prokinetic drugs that stimulate gastric emptying (domperidone, cisapride, metoclopramide).
•Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
•Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
•Current use of glucocorticoid medication.
•Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
•Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

Endpoints (14)

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
9
Safety / tolerability / PK
4
Other (unclassified)
1

Glycemic / diabetes

9 endpoints
Primary/protocol endpoint

Percentage of time of plasma glucose levels spent in target range. Target range is defined to be between 3.9 and 10.0 mmol/L of fast-acting insulin-plus-pramlintide closed-loop delivery vs. fast-acting insulin-alone closed-loop delivery.

Time frame:Up to 24 hours

CGM time-in-range

threshold achievement, improvement

Primary/protocol endpoint

Percentage of time of plasma glucose levels spent in target range. Target range is defined to be between 3.9 and 10.0 mmol/L of regular insulin-plus-pramlintide closed-loop delivery vs. fast-acting insulin-alone closed-loop delivery.

Time frame:Up to 24 hours

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of time of plasma glucose levels spent in target range, comparing fast-acting insulin-plus-pramlintide closed-loop delivery vs. regular insulin-plus-pramlintide closed-loop delivery.

Time frame:Up to 24 hours

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of time (8:00-8:00) of plasma glucose levels spent: a. 3.9-7.8 mmol/L; b. 3.9-10 mmol/L; c. <3.9 mmol/L; d. <3.3 mmol/L; e. <2.8 mmol/L; f. >7.8 mmol/L; g. >10 mmol/L; h. >13.9 mmol/L; i. >16.7 mmol/L

Time frame:Up to 24 hours

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of overnight time (23:00-8:00) of plasma glucose levels: a. 3.9-7.8 mmol/L; b. 3.9-10 mmol/L; c. <3.9 mmol/L; d. <3.3 mmol/L; e. <2.8 mmol/L; f. >7.8 mmol/L; g. >10 mmol/L; h. >13.9 mmol/L; i. >16.7 mmol/L

Time frame:Up to 24 hours

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Standard deviation of glucose levels as a measure of glucose variability.

Time frame:Up to 24 hours

descriptive

Secondary/protocol endpoint

Total insulin delivery.

Time frame:Up to 24 hours

descriptive

Secondary/protocol endpoint

Mean plasma glucose level during: a. the overall study period; b. overnight period.

Time frame:Up to 24 hours

descriptive

Secondary/protocol endpoint

Mean plasma insulin concentration.

Time frame:Up to 24 hours

concentration, descriptive

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Total pramlintide delivery.

Time frame:Up to 24 hours

descriptive

Secondary/protocol endpoint

Mean plasma amylin concentration.

Time frame:Up to 24 hours

concentration, descriptive

Secondary/protocol endpoint

Number of subjects experiencing hypoglycemia requiring oral treatment during: a. the overall study period; b. the night.

Time frame:Up to 24 hours

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Gastrointestinal symptoms during the treatment optimization (i.e., the minimum 10 days prior to the 24-hour closed-loop visits) and during the 24-hour closed-loop visits.

Time frame:Up to 24 hours

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Mean plasma glucagon concentration.

Time frame:Up to 24 hours

concentration, descriptive

Publications (2)

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.