MEXELIN

CompletedPhase 4Results posted

How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics

Metformin, Exenatide, and Glargine Insulin in Combination for Treatment of Patients With Type 2 Diabetes

Lead sponsor

Oregon Health and Science University

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-45•HbA1c 7-10%

Primary endpoint

•HbA1c <6.5% achievement

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 IDNCT00667732

Org study IDIND 75,235

Timeline

Milestones

Study first posted2008-04-28estimated

Last update posted2013-02-06estimated

Results first posted2013-02-06estimated

Study start2007-03 (month precision)

Primary completion2009-10actual (month precision)

Study completion2010-04actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female patients with type 2 diabetes

•Taking metformin at least 1000 mg daily plus a secretagogue, an alpha glucosidase inhibitor, a thiazolidinedione, or a single injection of any kind of insulin up to 0.4 units/kg daily for > 3 months

•Age range 30 to 70 years

•Body mass index 25-45 kg/m2

•HbA1c 7.0 to 10.0% (or 7.0 to 8.5% if the second antihyperglycemic agent is insulin)

•Less than 50% of randomized participants will have used insulin previously

Exclusion criteria

•Use of more than two antihyperglycemic agents within the last 3 months

•Use of more than one daily injection of any kind of insulin in the last 3 months

•Positive anti-GAD antibody (test required in screening)

•Fasting C-peptide <0.5 ng/mL (test required in screening)

•Pregnancy (test required in screening if able to conceive) or lactation

•Excessive use of alcohol or evidence of other form of drug dependency

•Unwillingness or inability to grant informed consent

•Unwillingness or inability to perform self-monitoring of blood glucose

•Unwillingness or inability to inject insulin and/or inject exenatide

•Serum creatinine >1.3 mg/dL in women or 1.4 in men

•Retinopathy which has required photocoagulation for treatment

•Major active systemic illness (e.g. neoplastic disorder, symptomatic ischemic heart disease, congestive heart failure) that might interfere with performing the study protocol

•Clinically significant gastrointestinal disorder including prior gastric or intestinal surgery for weight-control

•Ongoing use of any drug (e.g. narcotic analgesic, tricyclic antidepressant) that might alter gastric emptying

•Use prednisone or other systemic glucocorticoid drug in the last 3 months

•Use of any drug for weight-control (e.g. sibutramine, phentermine, orlistat) in the last 3 months

•Use of any unproven investigational drug within the last 3 months

Endpoints (2)

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

2 endpoints

Primary/protocol endpoint

The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment

Time frame:After 24 weeks of randomized treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Exenatide Group	47	5.7 – 9.3
Placebo Group	12	5.7 – 9.8

Secondary/protocol endpoint

The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment

Time frame:After 24 weeks of randomized treatment

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Exenatide Group	50	—
Placebo Group	12	—

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.