DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT01269034

CompletedPhase 4Results posted

New Onset Type 1 Diabetes: Role of Exenatide

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

13

actual

Study population

Healthy volunteers, Type 1 diabetes

Key I/E criterion

•Healthy volunteers

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 IDNCT01269034
Org study ID2010-435
Secondary ID3R01DK077166-05S1

Timeline

Milestones

Study first posted2011-01-04estimated
Primary completion2017-01-31actual
Study completion2017-01-31actual
Last update posted2021-08-04actual
Results first posted2021-08-04actual
Study start2010-12 (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteersType 1 diabetes

Eligibility

Who can enroll

Minimum age12 Years
Maximum age18 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Age between 12-18 years of age at the time of enrollment.

2. Diagnosed with antibody positive T1DM in the past 3 months.

3. Otherwise healthy except for their TIDM and treated hypothyroidism.

4. Females must have a negative pregnancy test.

5. Hemoglobin equal to or greater than 12 g/dl before each study.

6. Weight greater than 44 kg.

Exclusion criteria

1. Any chronic disease: leukemia, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc, except for diabetes and hypothyroidism.

2. Any medications that may affect glucose metabolism.

3. Abnormal AST, ALT, amylase, lipase, creatinine (more than 3 times normal values).

4. Lack of a supportive family environment as detected by the clinicians and/or social workers.

5. History of substance abuse (evaluated by medical history and CRAFFT questionnaire which will be administered at the screening visit).

6. Positive pregnancy test in females.

7. Lactating and nursing mothers.

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.

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

The Role of Exenatide as Compared to Insulin Monotherapy in Reducing Postprandial Hyperglycemia.

Time frame:February 2013

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

The Role of Exenatide on Postprandial Glucagon and Gastric Emptying.

Time frame:February 2013

descriptive

Secondary/protocol endpoint/low confidence

Postprandial Glucose Excursions, Glucagon Concentrations and Gastric Emptying in Normal Healthy Controls.

Time frame:February 2013

Postprandial glucose

descriptive

componentsPostprandial glucose, glucagon concentration, gastric emptying

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.