← Trials/Trial dossier/NCT00806520

Completed

Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control

Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control Addendum to: A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release to Those of Sitagliptin and Pioglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin (Study BCB106)

Asset

Exenatide

GLP-1 agonist

Listed sites

5

Recruiting sites

Enrollment

16

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI 25-45HbA1c 7.1-11%

Primary endpoint

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 IDNCT00806520
Org study ID03671-08-C

Timeline

Milestones

Study first posted2008-12-10estimated
Last update posted2015-12-02estimated
Study start2008-04 (month precision)
Primary completion2011-08actual (month precision)
Study completion2011-08actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Participants in the Amylin BCB106 Protocol Main Study

Inclusion criteria

18 years or older
type 2 diabetes
A1c 7.1 - 11
BMI 25 - 45
stable weight for 3 months before screening
fasting glucose < 280 at screening
stable dose of metformin for at least 2 months before screening
not being treated with or on a stable dose of hormone replacement therapy, oral contraceptives, anti-hypertensive agents, lipid lowering agents, thyroid replacement therapy, anti-depressants, drugs known to affect body weight
male or female, non-lactating, non-pregnant and willing to use birth control
lab values that are not clinically significant at screening
physical exam and ECG that are not clinically significant at screening
able to read, understand, and sign consent form

Exclusion criteria

liver disease
renal disease
cardiovascular disease
gastroparesis
cancer within 5 years of screening
macular edema
chronic infections
drug or alcohol abuse
fasting triglycerides > or = 600 at screening
previous exposure to exenatide LAR
has donated blood within 60 days of screening or is planning to donate during the study
has had a major surgery or blood transfusion within 2 months before screening
is currently being treated or is expecting to be treated with Byetta, Januvia, SU, TZD, GLP-1 analog, alpha-glucosidase inhibitor, meglitinide, nateglinide, symlin, insulin, systemic corticosteroids, lopid or rifampin
has received an investigational drug within 1 month before screening
has allergies or hypersensitivity to any component of the study drug
has previously had an adverse event related to TZD or Januvia
is an immediate family member of the study sight or directly affiliated
is employed by Amylin, Lilly or Alkermes

Endpoints (0)

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.

No endpoints recorded for this trial.

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.