Overview

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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Umbilical Cord Mesenchymal Stem Cell Infusion Combined With Liraglutide
glp-1
GLP-1 therapy
sc
Stem cell infusion
standard medical treatment SMT
Standard Medical Treatment
(Experimental)
Umbilical Cord Mesenchymal Stem Cell Infusion
sc
Stem cell infusion
standard medical treatment SMT
Standard Medical Treatment
(Experimental)
Liraglutide
glp-1
GLP-1 therapy
standard medical treatment SMT
Standard Medical Treatment
(Active Comparator)
Standard Medical Treatment
standard medical treatment SMT
Standard Medical Treatment

Primary Outcomes

Measure
HbA1C
time frame: 1 year

Secondary Outcomes

Measure
Fasting Blood Glucose
time frame: 1 year

Eligibility Criteria

Male or female participants from 35 years up to 65 years old.

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) .

Additional Information

Official title Umbilical Cord Mesenchymal Stem Cell Infusion With Liraglutide in Type 2 Diabetes Mellitus
Principal investigator Xiangjin Xu, Professor
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Diabetes Care Center of Nanjing Military Command.