← Trials/Trial dossier/NCT01954147

UnknownPhase 1, PHASE2

Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus

Umbilical Cord Mesenchymal Stem Cell Infusion With Liraglutide in Type 2 Diabetes Mellitus

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

100

estimated

Study population

Type 2 diabetes

Key I/E criteria

BMI ≤40HbA1c 7.5-11%

Primary endpoint

HbA1c, change

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 IDNCT01954147
Org study IDSC/GLP-1

Timeline

Milestones

Study first posted2013-10-01estimated
Last update posted2014-02-20estimated
Study start2013-10 (month precision)
Primary completion2014-10estimated (month precision)
Study completion2015-10estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age35 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Male and female patients age 35 to 65 years of age.
Ability to provide written informed consent.
Mentally stable and able to comply with the procedures of the study protocol.
Clinical history compatible with type 2 diabetes (T2DM) as defined by ADA(1997) on the Diagnosis and classification of Diabetes Mellitus
Basal C-peptide 0.5-2.0 ng/mL
HbA1c ≥ 7.5 and ≤ 11% before standard medical therapy (SMT).
Patients must have been treated with SMT for 1-4 months prior to matching. Insulin dose and metformin doses should be stable over 1 month prior to matching.
HbA1c ≥ 7.5 and ≤ 10% at time of matching.
Total insulin daily dose (TDD) at time of matching should not exceed 1.0 units/day/kg
18.5 kg/㎡≤BMI≤40.0kg/㎡

Exclusion criteria

Abnormal liver function >2.5 x ULN
Evidence of renal dysfunction:serum creatinine > 1.5 mg/dl (males) and 1.3 mg/dl (females).
Gastrointestinal operation history.
Type 1 Diabetes mellitus; DKA; secondary diabetes.
Uncontrolled blood Pressure: SBP >180 mmHg or DBP >100 mmHg at the time of matching.
Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
Presence of active proliferative diabetic retinopathy or macular edema.
Any acute or chronic infectious condition that in the criteria of the investigator would be a risk for the patient.
For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. For male participants: intent to procreate 3 months before or after the intervention or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant?, Depo-Provera?, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
Active infection including hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
Subjects that are being treated with any medication that could interfere with the outcome of the study such as: Thiazolidinediones and other glucagon like peptide 1 (GLP-1) analogues (Exenatide, Byetta), Pramlintide (Amylin), Dipeptidyl-peptidase IV (DPP-IV) inhibitors (i.e. Sitagliptin, Januvia)
Any known or suspected allergy to liraglutide or other relevant products.
Evidence of thyroid adverse events (serum calcitonin increase, goiter, thyroid cancer, et al) or pancreatitis caused by other GLP-1 analogues.
Subjects with past history or family history of Medullary Thyroid Carcinoma(MTC) or Multiple Endocrine Neoplasia Syndrome Type 2(MEN2) .

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

HbA1C

Time frame:1 year

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting Blood Glucose

Time frame:1 year

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

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.