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UnknownPhase 4

Effects of Liraglutide on ER Stress in Obese Patients With Type 2 Diabetes

Effects of Liraglutide on Endoplasmic (ER) Stress in Obese Patients With Type 2 Diabetes

Lead sponsor

Temple University

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

12

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI 27-35HbA1c 7-10%

Primary endpoint

Changes in unfolded protein response markers

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 IDNCT02344186
Org study ID21440

Timeline

Milestones

Study first posted2015-01-22estimated
Last update posted2022-07-29actual
Primary completion2022-12-31estimated
Study completion2023-12-31estimated
Study start2014-05 (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Patients with established type 2 diabetes, BMI 27-35, Age - 18-75 years, HbA1c 7-10%, patients treated with exercise, diet, metformin and/or alpha glucosidase inhibitors (all up to ½ of their maximal dose) or pioglitazone (up to 30 mg/d), ability to provide informed consent before any trial-related activities.

Exclusion criteria

Patients with pancreatitis or a history of pancreatitis, patients with HbA1c < 7% or > 10%, type 2 diabetic patients treated with insulin, sulfonylureas, meglitinides, dipeptidyl peptidase-4 (DPP4) inhibitors, glucagon-like peptide-1 (GLP1) agonists or corticosteroids, patients with hypoglycemia unawareness and with impaired liver functions (≥ 2.5 times the upper normal limit), known or suspected allergy against liraglutide or contraindications to liraglutide (as specified in the product prescribing information), pregnancies, breastfeeding or intention of becoming pregnant or not using adequate contraceptive measures, patients with a personal or family history of medullary thyroid cancer and patients with Multiple Endocrine Neoplasia type 2.

Endpoints (7)

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
3
Weight & body composition
2
Other (unclassified)
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Body weight

Time frame:baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body composition

Time frame:baseline, 3 months, 6 months and 9 months

descriptive

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Insulin sensitivity

Time frame:baseline, 3 months, 6 months and 9 months

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Glucose control

Time frame:baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Beta cell function

Time frame:baseline, 6 months, 9 months

descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Changes in unfolded protein response markers

Time frame:baseline, 6 months, 9 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Energy expenditure

Time frame:baseline, 3 months, 6 months, 9 months

change from baseline, descriptive

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.