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)

Lead sponsor

HealthPartners Institute

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 25-45•HbA1c 7.1-11%

Primary endpoint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. 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

Exenatide

Who this study enrolls

Obesity / overweightType 2 diabetes

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 6, 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 6, 2026 snapshot.