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CompletedPhase 2Results posted

Exeantide in Type 2 Diabetes on Insulin

The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

24

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥30HbA1c 7.5-9%

Primary endpoint

Fasting Insulin

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 IDNCT01154933
Org study ID1930

Timeline

Milestones

Study first posted2010-07-01estimated
Last update posted2022-10-06actual
Results first posted2022-10-06actual
Study start2008-04 (month precision)
Primary completion2011-11actual (month precision)
Study completion2011-11actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Males or females 20-75 years of age inclusive.
Type 2 diabetes
On insulin therapy
HbA1c ≥7.5% and ≤ 9%
BMI ≥ 30 kg/m2
Subjects on statins, ACE inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.

Exclusion criteria

Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
Pregnancy
Hepatic disease (abnormal LFT's)
Use of DPP4 inhibitors.
Renal impairment (serum creatinine > 1.5)
Participation in any other concurrent clinical trial
Any other life-threatening, non-cardiac disease
Uncontrolled hypertension (BP > 160/100 mm of Hg)
Congestive Heart Failure.
Use of an investigational agent or therapeutic regimen within 30 days of study

Endpoints (4)

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
2
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight

Time frame:value at 12 weeks minus value at baseline

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), lbs95% CI
Exenatide 10 mcg0
Placebo3

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Fasting Insulin

Time frame:after 24 hours fast at baseline and 12 weeks

change from baseline, improvement

Posted result

GroupValue (mean), μU/mL95% CI
Exenatide 10 mcgAt Baseline12.7
At 12 weeks16.4
PlaceboAt Baseline13.1
At 12 weeks13.9
Secondary/protocol endpoint

HbA1c

Time frame:value at 12 weeks minus value at baseline

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percent95% CI
Exenatide 10 mcg-1.2
Placebo-0.5

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Intranuclear NFκB Binding Activity

Time frame:measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline

NFkB intranuclear binding activity

change from baseline, improvement

Posted result

GroupValue (mean), % ratio of NFKB/Oct-195% CI
Exenatide 10 mcg26
Placebo0

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 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.