DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT03547427

TerminatedPhase NA

Glucagon Counterregulation in Type 1 Diabetes

Enhancement of Glucagon Counterregulation in Type 1 Diabetes by Basal Amylin Replacement

Asset

Pramlintide

Amylin analog

Listed sites

1

Recruiting sites

—

Enrollment

13

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c ≤10.5%

Primary endpoint

•Relative glucagon counterregulation (GCR) response

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 IDNCT03547427
Org study ID20364

Timeline

Milestones

Study start2018-05-20actual
Study first posted2018-06-06actual
Primary completion2019-03-11actual
Study completion2019-03-11actual
Last update posted2022-03-28actual

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age21 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 5 years and using insulin for at least 5 years
•Use of an insulin pump for at least 6 months with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
•HbA1c level <10.5% at screening
•Demonstration of proper mental status and cognition for the study
•Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol

Exclusion criteria

•Admission for diabetic ketoacidosis in the 6 months prior to enrollment.
•Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment.
•Hematocrit less that the lower limit of normal for the assay.
•Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures
•A known medical condition, which in the opinion of the investigator or designee, would put the participant or study at risk
•A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
•Current use of some drugs and supplements
•Participation in another pharmaceutical or device trial at the time of enrollment or during the study
•Basal insulin rates less than 0.01 units per hour
•Diagnosed food allergies that would prohibit the consumption of a standardized meal
•Any reason the study MD considers that the subject is not appropriate for the trial

Endpoints (3)

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
2
Other clinical outcomes
1

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint/low confidence

Relative glucagon counterregulation (GCR) response

Time frame:about 19 hours

ratio, descriptive

Secondary/protocol endpoint

Maximal glucagon counterregulation (GCR) response

Time frame:about 19 hours

concentration, descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Rate of gastric emptying

Time frame:about 4 hours

time to event, 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.