DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01708044

CompletedPhase 1

Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM

A Phase 1, Randomized, Placebo-Controlled Single-Blind, Dose-Ranging, 4-Way Crossover Study to Evaluate the Effect of Different Fixed Pramlintide: Insulin Dose Ratios on Postprandial Glycemic Control in Subjects With Type 1 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Pramlintide

Amylin analog

Listed sites

1

Recruiting sites

—

Enrollment

32

actual

Study population

Type 1 diabetes

Key I/E criteria

•BMI ≤30•HbA1c 7-9%

Primary endpoint

•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 IDNCT01708044
Org study IDD5570C00001

Timeline

Milestones

Study first posted2012-10-16estimated
Last update posted2014-10-20estimated
Study start2012-11 (month precision)
Primary completion2013-09actual (month precision)
Study completion2013-09actual (month precision)

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

•Is 18 to 70 years old
•Is male, or is female and meets all the following criteria:

1. Not breastfeeding

2. Negative pregnancy test result and, if of childbearing potential, must practice and be willing to continue to practice appropriate birth control

•Has been diagnosed with type 1 diabetes mellitus for at least 1 year and not achieving glycemic goal while on MDI of insulin
•Has HbA1c between 7.0% and 9.0%
•Has been on MDI of regular insulin, at a dose not to exceed 10 units/breakfast for at least 3 months or has been on continuous subcutaneous insulin infusion (CSII), at a dose not to exceed 10 units/breakfast, for at least 3 months and is willing to switch to an MDI insulin regimen for 1 day prior to enrollment and through the study
•Has a body mass index (BMI) <30 kg/m2

Exclusion criteria

•Has experienced recurrent severe hypoglycemia requiring assistance within 6 months before Visit 1 Screening
•Has a history of hypoglycemia unawareness
•Has a confirmed diagnosis of gastroparesis
•Has been treated, is currently being treated, or is expected to require or undergo treatment with the following medications:

1. Any antihyperglycemic agent other than insulin

2. Drugs that directly affect gastrointestinal motility (e.g., anticholinergic agents such as atropine)

3. Drugs that slow the intestinal absorption of nutrients (e.g., α-glucosidase inhibitors.

•Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:

1. Hepatic disease

2. Renal disease

3. Gastrointestinal disease

4. Pulmonary disease

5. Organ transplantation

6. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus)

•Is currently treated or has been previously treated with SYMLIN/pramlintide or has participated in a SYMLIN/pramlintide clinical study within 3 months of Visit 1 (Screening).
•Has any clinically significant laboratory findings or medical history that may affect successful completion of the study and/or personal well-being
•Has donated blood within 2 months or is planning to donate blood during the study.
•Has had a major surgery or a blood transfusion within 2 months
•Has received any investigational drug within 1 month
•Has known allergies or hypersensitivity to any component of study treatment.
•Is an immediate family member of personnel directly affiliated with the study at the clinical study site, or is directly affiliated with the study at the clinical study site.
•Is employed by Amylin Pharmaceuticals, Inc (Amylin) (that is an employee, temporary contract worker, or designee responsible for the conduct of the study).

Endpoints (5)

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

Safety / tolerability / PK
3
Glycemic / diabetes
2

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment

Time frame:AUC 0-3 hrs compared to Placebo

Postprandial glucose

concentration, improvement

Secondary/protocol endpoint/low confidence

Incremental AUC (0-3 h) of plasma glucagon

Time frame:0-3 hrs compared to Placebo

concentration, descriptive

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint/low confidence

Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose.

Time frame:0-3 hrs compared to Placebo

concentration, descriptive

Secondary/protocol endpoint

PK of pramlintide

Time frame:0-3 hrs compared to Placebo

concentration, descriptive

Secondary/protocol endpoint/low confidence

Safety

Time frame:0-3 hrs compared to Placebo

descriptive

Publications (1)

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.