T2DM

CompletedPhase 4

The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes

The Effect of the Glucagon Suppressors Pramlintide and Exenatide on Postprandial Glucose Metabolism in Children With Type 2 Diabetes Mellitus

Lead sponsor

Baylor College of Medicine

Assets

Exenatide / Pramlintide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≤8.5%

Primary endpoint

•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 IDNCT00950677

Org study IDH-22439

Secondary IDK23DK075931

Timeline

Milestones

Study first posted2009-08-03estimated

Last update posted2017-04-24actual

Study start2009-07 (month precision)

Primary completion2011-05actual (month precision)

Study completion2011-05actual (month precision)

Assets

Investigational agents

Exenatide Pramlintide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age12 Years

Maximum age21 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Children with Type 2 Diabetes,

•Between the ages of 12-21 years,

•Tanner stage 4-5 for pubertal development,

•Menstruating females must have a negative urine pregnancy test for inclusion,

•Must have T2DM for at least 6 months,

•History of negative anti-glutamic acid decarboxylase (GAD) -65 and anti-islet cell antibodies,

•HbA1c < 8.5% and on a stable dose of an oral hypoglycemic agent (with or without insulin) over the last 2 months, or well controlled on diet.

Exclusion criteria

•A history of a chronic disease other than diabetes (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, dyslipidemia, cholelithiasis etc),

•BMI> 40 kg/m2,

•Weight of < 60 kg,

•Female with menstrual irregularities,

•Allergy to local anesthetics (ELAMAX Cream, Ethyl Chloride),

•Evidence or history of chemical abuse,

•Anemia (age specific normal range for hemoglobin will be used),

•Elevated liver enzymes (defined as more than 3 times the upper limit of the normal range for age),

•Elevated BUN or creatinine (defined as more than 3 times the upper limit of the normal range for age),

•Use of medications that may increase the blood sugars and admission to the hospital for diabetes related problems over the last 6 months.

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

Glycemic / diabetes

Other clinical outcomes

Other (unclassified)

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Glucose

Time frame:4 hours

concentration, descriptive

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

pramlintide concentrations

Time frame:4 hours

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

exenatide concentrations

Time frame:4 hours

Plasma concentration (steady state)

concentration, descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

gastric emptying

Time frame:4 hours

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

glucagon

Time frame:4 hrours

concentration, descriptive

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.