← Trials/Trial dossier/NCT00803920

Completed

Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes Taking Twice-Daily Exenatide or Once-Weekly Exenatide

CGM Substudy, Addendum 2, of the Following Exenatide LAR Protocol 2993LAR-105: A Randomized, Open-Label, Multicenter, Comparator Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications)

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

8

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 25-45HbA1c 7.1-11%

Primary endpoint

Characterize glucose control

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 IDNCT00803920
Org study ID03404-06-C

Timeline

Milestones

Study first posted2008-12-08estimated
Last update posted2015-12-03estimated
Study start2006-12 (month precision)
Primary completion2008-02actual (month precision)
Study completion2008-02actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age16 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Up to eighteen subjects at the International Diabetes Center study site will be selected for this substudy in accordance with protocol 2993LAR-105

Inclusion criteria

participant in Amylin Protocol 2993LAR-105
at least 16 years of age
type 2 diabetes being treated with stable regiment of metformin, SU, TZD, combination of metformin/SU, combination metformin/TZD, combination SU/TZD
A1c 7.1 - 11
fasting glucose less than 280 at screening
BMI 25 - 45
stable body weight 6 months prior to screening
not pregnant and willing to practice birth control
physical exam \& ECG not clinically significant
lab values judged not to be clinically significant
able to understand \& sign consent form

Exclusion criteria

clinically significant medical condition as judged by investigator
drug or alcohol abuse
previous use of exenatide or any GLP-1 analog
has used any investigational drug in the past 30 days prior to screening
is currently using: alpha-glucosidase inhibitor, insulin, drugs that affect GI motility, use of systemic corticosteroids, use of medications with addictive potential, prescription or OTC weight-loss medications
has donated blood within 60 days of screening, or is planning to donate during the study
has had major surgery or blood transfusion within 2 months of screening
has had a surgical procedure that may impact gastric emptying
has any allergies or hypersensitivity to any component of study treatment
is an immediate family member of personnel affiliated with the study at the investigative site
is employed by Amylin, Lilly or Alkermes

Endpoints (1)

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

1 endpoint
Primary/protocol endpoint

Characterize glucose control using periodic CGM in subjects participating in protocol 2993LAR-105 at the International Diabetes Center study site.

Time frame:2 week periods of time - 3 times during study:

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.