← Trials/Trial dossier/NCT01434862

ALM002

TerminatedPhase NA

Pramlintide Combined With Model Predictive Control Algorithm

Lead sponsor

University of Virginia

Asset

Pramlintide

Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criteria

•HbA1c 7-9%•eGFR ≥60

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 IDNCT01434862

Org study ID15401

Timeline

Milestones

Study first posted2011-09-15estimated

Last update posted2014-05-01estimated

Study start2011-02 (month precision)

Primary completion2012-02actual (month precision)

Study completion2012-02actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age21 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least six months (the diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determination are not needed).

•Age 21 to 65 years

•For females, not currently known to be pregnant

•An understanding of the protocol and a willingness to follow it

•HbA1c between 7 and 9%

•Normal renal function (determined utilizing the comprehensive metabolic panel at screening with the Modification of Diet in Renal Disease (MDRD) formula and defined by estimated Glomerular Filtration Rate (eGFR) of ≥60 ml/min/1.73 m2.

•Hematocrit >36 (females); >38 (males)

Exclusion criteria

•Known hypersensitivity to SYMLIN or any of its components, including metacresol

•Poor compliance with current insulin regimen

•Poor compliance with prescribed self-blood glucose monitoring

•HbA1c <7 or >9%

•Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to enrollment

•Active infection

•Current use of dietary supplements (subjects may be enrolled if they stop taking dietary supplements two weeks prior to admission and for the duration of their participation)

•Active gastroparesis

•Use of drugs that stimulate gastrointestinal motility (e.g. metoclopramide)

•Diabetic ketoacidosis in the past 3 months

•Current treatment for a seizure disorder

•Cystic fibrosis

•Asthma requiring hospitalization or treatment with oral steroids within the past year

•Presence of a uncontrolled adrenal disorder

•A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:

–Inpatient psychiatric treatment in the past 6 months

–Abnormal liver function (Transaminase >2 times the upper limit of normal)

–Heart failure

–Coronary artery disease

–Arrhythmia

–Seizure disorder

–Any carcinogenic disease

–Creatinine concentration above the upper limit of normal for age and sex

–Active coronary artery disease

–Uncontrolled thyroid disease

–Use or abuse of alcohol

–Active kidney dialysis

–If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study

–Note: adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment

•Addison's disease

•Current use of a beta blocker medication

•Hematocrit < 36 (female), <38 (male)

•Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study

•Allergy to the sensor or to one of its components

•Continued use of acetaminophen.

Endpoints (2)

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.

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Percent of Blood glucose tests within target range of 70 to 180 mg/dl

Time frame:24 hours

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Percent of Continuous Glucose Monitoring (CGM) System estimated blood glucose within target range of 70 to 180 mg/dl

Time frame:72 hours

CGM time-in-range

threshold achievement, improvement

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.