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A Comparison of Exenatide and Insulin Glargine
A Comparison of Exenatide and Insulin Glargine on Glycemic Variability in T2DM Patients Inadequately Controlled With Metformin Monotherapy
Asset
Exenatide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
44
actual
Study population
Type 2 diabetes
Key I/E criterion
—
Primary endpoint
•Mean amplitude of glycemic excursions (MAGE) change from baseline by continuous
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Provision of informed consent prior to any study specific procedures
2. Type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
3. Male or female age ≧ 18 years and ≦70 years old
4. HbA1c ≧7.0 and ≦10%
5. BMI ≧ 24 kg/m2
Exclusion criteria
1. Known or suspected allergy to trial products or related products.
2. Impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 133 umol/l).
3. Acute or chronic disease which may cause tissue hypoxia such as respiratory failure or shock.
4. Abnormal liver function, alanine transaminase or aspartate aminotransferase ≥ 3 fold normal upper limit, Total bilirubin ≥ 2 normal upper limit, acute alcohol intoxication, alcoholism.
5. Subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association-class Ⅲ and Ⅳ).
6. Proliferative retinopathy or muscular oedema requiring acute treatment.
7. Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
8. Treatment with systemic corticosteroids within the past two months prior to screening.
9. Type 1 diabetes mellitus.
10. Receipt of any investigational drug within 1 month prior to this trial.
Endpoints (10)
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
Weight & body composition
1 endpointbody composition
Time frame:1±3d;112±3d
descriptive, improvement
Glycemic / diabetes
4 endpointsMean amplitude of glycemic excursions (MAGE) change from baseline by continuous glucose monitoring system (CGMS)
Time frame:1±3day;112±3d
change from baseline, improvement
Glycemic variability
Time frame:1±3day;112±3d
descriptive, improvement
Glucose control
Time frame:-7±3d;112±3d;
descriptive, improvement
beta-cell function and insulin resistance
Time frame:1±3d;112±3d;
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsinflammatory markers
Time frame:1±3d;28±3d;56±3d;84±3d;112±3d
Adiponectin, change
change from baseline, improvement
endothelial function
Time frame:1±3d;28±3d;56±3d;84±3d;112±3d
change from baseline, improvement
Safety / tolerability / PK
1 endpointNumber of Participants with exenatide or insulin glargine adverse events as a measure of safety and tolerability:
Time frame:-7±3d;1±3d;7±2d;14±3d;21±2d;28±3d;35±3d;56±3d;84±3d;112±3d
Treatment-emergent AEs (any)
event count, event
Other (unclassified)
2 endpointsoxidative stress markers
Time frame:1±3d;28±3d;56±3d;84±3d;112±3d
concentration, descriptive
Exploratory Objective assessed by the relationships between oxidative stress and inflammatory markers and MAGE
Time frame:1±3d;112±3d
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Nutrition & metabolism2018 (year)PMID30302121doi:10.1186/s12986-018-0295-6via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.