DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06422325

CompletedPhase NAResults posted

Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

A Crossover Study to Evaluate Insulin/Pramlintide Versus Insulin Alone Delivery Strategy

Asset

Pramlintide

Intravenous · Amylin analog

Listed sites

1

Recruiting sites

—

Enrollment

33

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c ≤10.5%

Primary endpoints

•Incremental Area Under the Curve of Postprandial Glucose Following the First•Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal•Postprandial glucose

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 IDNCT06422325
Org study ID25279

Timeline

Milestones

Study first posted2024-05-20actual
Study start2024-07-12actual
Primary completion2025-01-04actual
Study completion2025-01-28actual
Last update posted2026-03-05actual
Results first posted2026-03-05actual

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

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 OR current use of multiple day injection insulin therapy with stable doses for >2 weeks.
•Uses a carbohydrate ratio, at lease occasionally, to dose meal time insulin.
•HbA1c ≤ 10.5% at screening.
•Total daily insulin requirement is less than 139 units/day.
•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 OHSU 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. 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.
•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 to 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 any medication intended to lower glucose other than insulin or pramlintide (ex. use of liraglutide, metformin).
•Gastroparesis
•Diets consisting of less than 50 grams of carbohydrates per day.
•Dietary restrictions or allergies to the study meals
•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 (96)

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
69
Safety / tolerability / PK
24
Other (unclassified)
3

Glycemic / diabetes

69 endpoints
Primary/registry result

Incremental Area Under the Curve of Postprandial Glucose Following the First Meal

Time frame:6 hours following first meal

descriptive

Posted result

GroupValue (mean), (mg/dl*min)/100095% CI
Insulin and Pramlintide Arm18.1—
Insulin Only Arm20.9—
Adjusted mean difference-5.995% CI-10.8 – -1.1p0.017Mixed Models Analysis
Primary/registry result

Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal

Time frame:6 hours following first meal

descriptive

Posted result

GroupValue (mean), Percent time in range95% CI
Insulin and Pramlintide Arm50.5—
Insulin Only Arm44.3—
Mean Difference (Final Values)6.395% CI-3.7 – 16.4p0.218Mixed Models Analysis
Primary/protocol endpoint

Incremental Area Under the Curve of Postprandial Glucose Following the First Meal

Time frame:6 hours following first meal

Postprandial glucose

descriptive, improvement

Primary/protocol endpoint

Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal

Time frame:6 hours following first meal

CGM time-in-range

descriptive, improvement

Secondary/registry result

Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal

Time frame:6 hours following second meal

descriptive

Posted result

GroupValue (mean), (mg/dl*min)/100095% CI
Insulin and Pramlintide Arm11.0—
Insulin Only Arm23.4—
Secondary/registry result

Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following Second Meal

Time frame:6 hours following second meal

descriptive

Posted result

GroupValue (mean), Percent time in range95% CI
Insulin and Pramlintide Arm74.4—
Insulin Only Arm49.3—
Secondary/registry result

Net Area Under the Curve of Postprandial Glucose Following the First Meal

Time frame:6 hours following first meal

descriptive

Posted result

GroupValue (mean), (mg/dL*min)/100095% CI
Insulin and Pramlintide Arm14.9—
Insulin Only Arm15.0—
Secondary/registry result

Net Area Under the Curve of Postprandial Glucose Following the Second Meal

Time frame:6 hours following second meal

descriptive

Posted result

GroupValue (mean), (mg/dl *min)/100095% CI
Insulin and Pramlintide Arm6.4—
Insulin Only Arm22.2—
Secondary/registry result

Net Area Under the Curve of Postprandial Glucose

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (mean), (mg/dL*min)/100095% CI
Insulin and Pramlintide Arm6.6—
Insulin Only Arm22.2—
Secondary/registry result

Percent of Time With Sensed Glucose <70 mg/dL Following First Meal

Time frame:6 hours following first meal

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm5—
Insulin Only Arm6—
Secondary/registry result

Percent of Time With Sensed Glucose <70 mg/dL Following Second Meal

Time frame:6 hours following second meal

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm10—
Insulin Only Arm6—
Secondary/registry result

Percent of Time With Sensed Glucose <70 mg/dL

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm14—
Insulin Only Arm11—
Secondary/registry result

Percent of Time With Sensed Glucose Between 70-140 mg/dL Following First Meal

Time frame:6 hours following first meal

descriptive

Posted result

GroupValue (median), Percent time in range (mg/dl)95% CI
Insulin and Pramlintide Arm298 – 46
Insulin Only Arm217 – 39
Secondary/registry result

Percent of Time With Sensed Glucose Between 70-140 mg/dL Following Second Meal

Time frame:6 hours following second meal

descriptive

Posted result

GroupValue (median), Percent time in range (mg/dl)95% CI
Insulin and Pramlintide Arm4832 – 68
Insulin Only Arm2110 – 38
Secondary/registry result

Percent of Time With Sensed Glucose Between 70-140 mg/dL

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (median), Percent time in range (mg/dl)95% CI
Insulin and Pramlintide Arm3924 – 58
Insulin Only Arm2315 – 35
Secondary/registry result

Mean Sensed Glucose Following First Meal

Time frame:6 hours following first meal

descriptive

Posted result

GroupValue (mean), mg/dL95% CI
Insulin and Pramlintide Arm184—
Insulin Only Arm204—
Secondary/registry result

Mean Sensed Glucose Following Second Meal

Time frame:6 hours following second meal

descriptive

Posted result

GroupValue (mean), mg/dL95% CI
Insulin and Pramlintide Arm148—
Insulin Only Arm183—
Secondary/registry result

Mean Sensed Glucose

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (mean), mg/dL95% CI
Insulin and Pramlintide Arm166—
Insulin Only Arm194—
Secondary/registry result

Percent of Time With Sensed Glucose <54 mg/dL Following First Meal

Time frame:6 hours following first meal

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm1—
Insulin Only Arm1—
Secondary/registry result

Percent of Time With Sensed Glucose <54 mg/dL Following Second Meal

Time frame:6 hours following second meal

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm3—
Insulin Only Arm2—
Secondary/registry result

Percent of Time With Sensed Glucose <54 mg/dL

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm4—
Insulin Only Arm3—
Secondary/registry result

Percent of Time With Sensed Glucose >180 mg/dL Following First Meal

Time frame:6 hours following first meal

descriptive

Posted result

GroupValue (mean), Percent time in range95% CI
Insulin and Pramlintide Arm48—
Insulin Only Arm55—
Secondary/registry result

Percent of Time With Sensed Glucose >180 mg/dL Following Second Meal

Time frame:6 hours following second meal

descriptive

Posted result

GroupValue (mean), Percent time in range95% CI
Insulin and Pramlintide Arm23—
Insulin Only Arm49—
Secondary/registry result

Percent of Time With Sensed Glucose >180 mg/dL

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (mean), percent of time95% CI
Insulin and Pramlintide Arm36—
Insulin Only Arm52—
Secondary/registry result

Percent of Time With Sensed Glucose >250 mg/dL Following First Meal

Time frame:6 hours following first meal

descriptive

Posted result

GroupValue (median), Percent time in range95% CI
Insulin and Pramlintide Arm70 – 38
Insulin Only Arm3312 – 51
Secondary/registry result

Percent of Time With Sensed Glucose >250 mg/dL Following Second Meal

Time frame:6 hours following second meal

descriptive

Posted result

GroupValue (median), Percent time in range95% CI
Insulin and Pramlintide Arm00 – 0
Insulin Only Arm60 – 26
Secondary/registry result

Percent of Time With Sensed Glucose >250 mg/dL

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (median), Percent time in range95% CI
Insulin and Pramlintide Arm40 – 19
Insulin Only Arm2315 – 31
Secondary/registry result

Median Amount of Insulin Delivered Following First Meal

Time frame:6 hours following the first meal

descriptive

Posted result

GroupValue (median), Units95% CI
Insulin and Pramlintide Arm11.17.9 – 16.4
Insulin Only Arm11.17.9 – 15.7
Secondary/registry result

Median Amount of Insulin Delivered Following Second Meal

Time frame:6 hours following the second meal

descriptive

Posted result

GroupValue (median), Units95% CI
Insulin and Pramlintide Arm9.16.9 – 13.3
Insulin Only Arm11.87.9 – 14.9
Secondary/registry result

Median Amount of Insulin Delivered

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (median), Units95% CI
Insulin and Pramlintide Arm20.116.6 – 25.7
Insulin Only Arm22.416.1 – 36.2
Secondary/registry result

Median Amount of Pramlintide Delivered Following First Meal

Time frame:6 hours following the first meal

descriptive

Posted result

GroupValue (median), mcg95% CI
Insulin and Pramlintide Arm65.446.7 – 96.0
Secondary/registry result

Median Amount of Pramlintide Delivered Following Second Meal

Time frame:6 hours following the second meal

descriptive

Posted result

GroupValue (median), mcg95% CI
Insulin and Pramlintide Arm51.841.0 – 78.4
Secondary/registry result

Median Amount of Pramlintide Delivered

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (median), mcg95% CI
Insulin and Pramlintide Arm117.297.3 – 149.1
Secondary/registry result

Low Blood Glucose Index (LBGI) Following the First Meal

Time frame:6 hours following the first meal

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm28—
2—
1—
Insulin Only Arm28—
3—
0—
Secondary/registry result

Low Blood Glucose Index (LBGI) Following the Second Meal

Time frame:6 hours following the second meal

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm24—
5—
1—
Insulin Only Arm27—
3—
1—
Secondary/registry result

Low Blood Glucose Index (LBGI)

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm28—
2—
1—
Insulin Only Arm29—
1—
1—
Secondary/registry result

High Blood Glucose Index (HBGI) Following the First Meal

Time frame:6 hours following the first meal

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm7—
10—
14—
Insulin Only Arm4—
4—
23—
Secondary/registry result

High Blood Glucose Index (HBGI) Following the Second Meal

Time frame:6 hours following the second meal

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm20—
6—
4—
Insulin Only Arm4—
11—
16—
Secondary/registry result

High Blood Glucose Index (HBGI)

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm10—
10—
11—
Insulin Only Arm3—
2—
26—
Secondary/registry result

Adverse Events Related to Pramlintide

Time frame:4 days of pramlintide use

descriptive

Posted result

GroupValue (number), Number of events95% CI
Insulin and Pramlintide Arm16—
Secondary/registry result

Number of Provider-administered Insulin Injections

Time frame:12 hour clinic visit

event count, event

Posted result

GroupValue (mean), count of injections95% CI
Insulin and Pramlintide Arm0—
Insulin Only Arm0—
Secondary/protocol endpoint

Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal

Time frame:6 hours following second meal

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following Second Meal

Time frame:6 hours following second meal

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Net Area Under the Curve of Postprandial Glucose Following the First Meal

Time frame:6 hours following first meal

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Net Area Under the Curve of Postprandial Glucose Following the Second Meal

Time frame:6 hours following second meal

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Net Area Under the Curve of Postprandial Glucose

Time frame:12 hour clinic visit

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Percent of Time With Sensed Glucose Between 70-140 mg/dL Following First Meal

Time frame:6 hours following first meal

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Percent of Time With Sensed Glucose Between 70-140 mg/dL Following Second Meal

Time frame:6 hours following second meal

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Percent of Time With Sensed Glucose Between 70-140 mg/dL

Time frame:12 hour clinic visit

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Mean Sensed Glucose Following First Meal

Time frame:6 hours following first meal

Postprandial glucose

descriptive

Secondary/protocol endpoint

Mean Sensed Glucose Following Second Meal

Time frame:6 hours following second meal

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Mean Sensed Glucose

Time frame:12 hour clinic visit

descriptive

Secondary/protocol endpoint

Percent of Time With Sensed Glucose >180 mg/dL Following First Meal

Time frame:6 hours following first meal

CGM time-above-range

threshold achievement, improvement

Secondary/protocol endpoint

Percent of Time With Sensed Glucose >180 mg/dL Following Second Meal

Time frame:6 hours following second meal

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

Percent of Time With Sensed Glucose >180 mg/dL

Time frame:12 hour clinic visit

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

Percent of Time With Sensed Glucose >250 mg/dL Following First Meal

Time frame:6 hours following first meal

CGM time-above-range

threshold achievement, improvement

Secondary/protocol endpoint

Percent of Time With Sensed Glucose >250 mg/dL Following Second Meal

Time frame:6 hours following second meal

CGM time-above-range

threshold achievement, improvement

Secondary/protocol endpoint

Percent of Time With Sensed Glucose >250 mg/dL

Time frame:12 hour clinic visit

CGM time-above-range

threshold achievement, improvement

Secondary/protocol endpoint

Median Amount of Insulin Delivered Following First Meal

Time frame:6 hours following the first meal

descriptive

Secondary/protocol endpoint

Median Amount of Insulin Delivered Following Second Meal

Time frame:6 hours following the second meal

descriptive

Secondary/protocol endpoint

Median Amount of Insulin Delivered

Time frame:12 hour clinic visit

descriptive

Secondary/protocol endpoint

Coefficient of Variation Following First Meal

Time frame:6 hours following the first meal

descriptive

Secondary/protocol endpoint/low confidence

Coefficient of Variation Following Second Meal

Time frame:6 hours following the second meal

descriptive

Secondary/protocol endpoint

Coefficient of Variation

Time frame:12 hour clinic visit

ratio, improvement

Secondary/protocol endpoint

Low Blood Glucose Index (LBGI) Following the First Meal

Time frame:6 hours following the first meal

descriptive, improvement

Secondary/protocol endpoint

Low Blood Glucose Index (LBGI)

Time frame:12 hour clinic visit

descriptive, improvement

Secondary/protocol endpoint

High Blood Glucose Index (HBGI) Following the First Meal

Time frame:6 hours following the first meal

descriptive, improvement

Secondary/protocol endpoint

High Blood Glucose Index (HBGI) Following the Second Meal

Time frame:6 hours following the second meal

descriptive, improvement

Secondary/protocol endpoint

High Blood Glucose Index (HBGI)

Time frame:12 hour clinic visit

descriptive, improvement

Safety / tolerability / PK

24 endpoints
Secondary/registry result

Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the First Meal

Time frame:6 hours following first meal

descriptive

Posted result

GroupValue (median), score on the scale95% CI
Insulin and Pramlintide Arm0.00.0 – 7.2
Insulin Only Arm0.00 – 1.0
Secondary/registry result

Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the Second Meal

Time frame:6 hours following second meal

descriptive

Posted result

GroupValue (median), score on the scale95% CI
Insulin and Pramlintide Arm0.00.0 – 8.2
Insulin Only Arm0.00.0 – 3.0
Secondary/registry result

Mean Duration of Gastrointestinal Issues After the First Meal

Time frame:6 hours following first meal

ratio, event

Posted result

GroupValue (mean), Minutes95% CI
Insulin and Pramlintide Arm450 – 360
Insulin Only Arm10 – 30
Secondary/registry result

Mean Duration of Gastrointestinal Issues After the Second Meal

Time frame:6 hours following second meal

ratio, event

Posted result

GroupValue (mean), Minutes95% CI
Insulin and Pramlintide Arm410 – 360
Insulin Only Arm40 – 120
Secondary/registry result

Episodes of Hypoglycemia

Time frame:12 hour clinic visit

event count, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin and Pramlintide Arm19—
12—
0—
0—
Insulin Only Arm21—
7—
2—
1—
Secondary/registry result

Episodes of Carbohydrate Intake to Treat Hypoglycemia

Time frame:12 hour clinic visit

event count, event

Posted result

GroupValue (mean), number of events95% CI
Insulin and Pramlintide Arm0.7—
Insulin Only Arm0.5—
Secondary/protocol endpoint

Percent of Time With Sensed Glucose <70 mg/dL Following First Meal

Time frame:6 hours following first meal

CGM time-below-range

threshold achievement, event

Secondary/protocol endpoint

Percent of Time With Sensed Glucose <70 mg/dL Following Second Meal

Time frame:6 hours following second meal

CGM time-below-range

threshold achievement, event

Secondary/protocol endpoint

Percent of Time With Sensed Glucose <70 mg/dL

Time frame:12 hour clinic visit

CGM time-below-range

threshold achievement, event

Secondary/protocol endpoint

Percent of Time With Sensed Glucose <54 mg/dL Following First Meal

Time frame:6 hours following first meal

CGM time-below-range

threshold achievement, event

Secondary/protocol endpoint

Percent of Time With Sensed Glucose <54 mg/dL Following Second Meal

Time frame:6 hours following second meal

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Percent of Time With Sensed Glucose <54 mg/dL

Time frame:12 hour clinic visit

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Median Amount of Pramlintide Delivered Following First Meal

Time frame:6 hours following the first meal

descriptive

Secondary/protocol endpoint

Median Amount of Pramlintide Delivered Following Second Meal

Time frame:6 hours following the second meal

descriptive

Secondary/protocol endpoint

Median Amount of Pramlintide Delivered

Time frame:12 hour clinic visit

descriptive

Secondary/protocol endpoint

Low Blood Glucose Index (LBGI) Following the Second Meal

Time frame:6 hours following the second meal

descriptive

Secondary/protocol endpoint

Adverse Events Related to Pramlintide

Time frame:4 days of pramlintide use

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the First Meal

Time frame:6 hours following first meal

descriptive

Secondary/protocol endpoint

Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the Second Meal

Time frame:6 hours following second meal

descriptive

Secondary/protocol endpoint

Mean Duration of Gastrointestinal Issues After the First Meal

Time frame:6 hours following first meal

Nausea

descriptive

Secondary/protocol endpoint

Mean Duration of Gastrointestinal Issues After the Second Meal

Time frame:6 hours following second meal

Nausea

descriptive

Secondary/protocol endpoint

Episodes of Hypoglycemia

Time frame:12 hour clinic visit

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Episodes of Carbohydrate Intake to Treat Hypoglycemia

Time frame:12 hour clinic visit

event count, event

Secondary/protocol endpoint

Number of Provider-administered Insulin Injections

Time frame:12 hour clinic visit

event count, event

Other (unclassified)

3 endpoints
Secondary/registry result/low confidence

Coefficient of Variation Following First Meal

Time frame:6 hours following the first meal

descriptive

Posted result

GroupValue (mean), Unitless95% CI
Insulin and Pramlintide Arm24.8—
Insulin Only Arm33.0—
Secondary/registry result/low confidence

Coefficient of Variation Following Second Meal

Time frame:6 hours following the second meal

descriptive

Posted result

GroupValue (mean), Unitless95% CI
Insulin and Pramlintide Arm23.2—
Insulin Only Arm26.6—
Secondary/registry result/low confidence

Coefficient of Variation

Time frame:12 hour clinic visit

descriptive

Posted result

GroupValue (mean), Unitless95% CI
Insulin and Pramlintide Arm28.7—
Insulin Only Arm33.8—

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.