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CompletedPhase 4

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

NCT IDNCT02325960
Org study IDISSEXEN0034

Timeline

Milestones

Study first posted2014-12-25estimated
Last update posted2017-02-23actual
Study start2015-01 (month precision)
Primary completion2016-07actual (month precision)
Study completion2016-10actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
4
Cardiometabolic biomarkers
2
Other (unclassified)
2
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

body composition

Time frame:1±3d;112±3d

descriptive, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Mean amplitude of glycemic excursions (MAGE) change from baseline by continuous glucose monitoring system (CGMS)

Time frame:1±3day;112±3d

change from baseline, improvement

Secondary/protocol endpoint

Glycemic variability

Time frame:1±3day;112±3d

descriptive, improvement

Secondary/protocol endpoint

Glucose control

Time frame:-7±3d;112±3d;

descriptive, improvement

Secondary/protocol endpoint

beta-cell function and insulin resistance

Time frame:1±3d;112±3d;

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint/low confidence

inflammatory markers

Time frame:1±3d;28±3d;56±3d;84±3d;112±3d

Adiponectin, change

change from baseline, improvement

Secondary/protocol endpoint

endothelial function

Time frame:1±3d;28±3d;56±3d;84±3d;112±3d

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

Number 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 endpoints
Secondary/protocol endpoint/low confidence

oxidative stress markers

Time frame:1±3d;28±3d;56±3d;84±3d;112±3d

concentration, descriptive

Other/protocol endpoint/low confidence

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

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.