Not yet recruitingPhase NA

Outpatient Pramlintide Study

An Outpatient Crossover Study to Evaluate Insulin and Pramlintide Versus Insulin Alone Delivery Strategy

Lead sponsor

Oregon Health and Science University

Asset

Pramlintide

Amylin analog

Listed sites

Recruiting sites

Estimated enrollment

Study population

Type 1 diabetes

Eligibility highlights

•HbA1c ≤10.5%

Primary endpoint

•Percent of time with sensed glucose between 70-180 mg/dl

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07914621

Org study IDSTUDY00029226

Secondary ID1R01DK129382-01

Timeline

Milestones

Study start2026-11-02estimated

Study first posted2026-11-03actual

Last update posted2026-11-03actual

Primary completion2027-01-31estimated

Study completion2027-01-31estimated

Assets

Investigational agents

Pramlintide

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of type 1 diabetes mellitus for at least 1 year.

•Participants 18 to 70 years of age.

•Current use of an insulin pump for at least 3 months with stable insulin pump settings for >2 weeks.

•Uses a carbohydrate ratio, at least occasionally, to dose meal-time insulin

•HbA1c ≤ 10.5% at screening.

•Total daily insulin requirement is less than 139 units/day.

•Lives with another person age 18 or older who will sleep in the house at night and that can attend the training on using the system.

•Current use of a smartphone so can be contacted by study staff off-campus

•Willingness to follow all study procedures, including attending all clinic visits.

•Willingness to sign informed consent and HIPAA documents.

Exclusion criteria

•Individual of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.

•Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.

•Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as reported by the site laboratory).

•Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.

•History of severe hypoglycemia during the past 3 months prior to screening visit or hypoglycemia unawareness as judged by the investigator.

•Participants will complete a hypoglycemia awareness questionnaire included in Appendix A. Participants will be excluded for four or more R responses.

•History of diabetes ketoacidosis during the prior 3 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.

•Adrenal insufficiency.

•Any active infection requiring treatment (example soft tissue infection requiring antibiotics).

•Known or suspected abuse of alcohol, narcotics, or illicit drugs.

•Seizure disorder.

•Active foot ulceration.

•Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.

•Major surgical operation within 30 days prior to screening.

•Use of an investigational drug within 30 days prior to screening.

•Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).

•Bleeding disorder, treatment with warfarin, or platelet count below 50,000.

•Allergy to Aspart insulin.

•Allergy or intolerance of pramlintide.

•Current administration of oral or parenteral corticosteroids.

•Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).

•Current use of beta blockers or non-dihydropyridine calcium channel blockers.

•Current use of any medication that may lower glucose other than insulin or pramlintide (ex. use of liraglutide, metformin, empaglifozin etc) including the use of GLP1RA medications for weight loss (ex. Wegovy or Zepbound).

•Gastroparesis or history of chronic nausea and/or frequent emesis.

•Low carbohydrate diet at the time of screening defined as less than 50 grams of carbohydrate per day.

•Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol

Endpoints (19)

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

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

16 endpoints

Primary/protocol endpoint

Percent of time with sensed glucose between 70-180 mg/dl

Time frame:12 hours following in-clinic visit

descriptive

Secondary/protocol endpoint

Incremental area under the curve of postprandial glucose

Time frame:6 hours following the start of standarized in-clinic meal

descriptive

Secondary/protocol endpoint

Percent of time with sensed glucose <70 mg/dl