Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus
This trial is active, not recruiting.
|Condition||type 2 diabetes|
|Treatments||glp-1, sc, standard medical treatment|
|Phase||phase 1/phase 2|
|Sponsor||Diabetes Care Center of Nanjing Military Command|
|Start date||October 2013|
|End date||October 2014|
|Trial size||100 participants|
|Trial identifier||NCT01954147, SC/GLP-1|
Umbilical cord mesenchymal stem cells (SC) transplantation was a novel therapy for diabetes mellitus, with less side effects and more advantages. Clinical trials had verified that good metabolic control would be achieved when Liraglutide (GLP-1) was added to the conventional therapies. The investigators hypothesized that the combined therapy of umbilical cord mesenchymal stem cells transplantation and Liraglutide in type 2 diabetes mellitus will aid the differentiation of stem cells into insulin-producing cells, improve the survival of differentiated cells, protect the residual beta-cells and improve insulin secreting function, so as to achieve a favorable glucose homeostasis.
|Endpoint classification||safety/efficacy study|
|Intervention model||factorial assignment|
time frame: 1 year
Fasting Blood Glucose
time frame: 1 year
Male or female participants from 35 years up to 65 years old.
- 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/㎡
- 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) .
|Official title||Umbilical Cord Mesenchymal Stem Cell Infusion With Liraglutide in Type 2 Diabetes Mellitus|
|Principal investigator||Xiangjin Xu, Professor|
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