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Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01954147
Recruitment Status : Unknown
Verified February 2014 by Diabetes Care Center of Nanjing Military Command.
Recruitment status was:  Active, not recruiting
First Posted : October 1, 2013
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):
Diabetes Care Center of Nanjing Military Command

Tracking Information
First Submitted Date  ICMJE August 13, 2013
First Posted Date  ICMJE October 1, 2013
Last Update Posted Date February 20, 2014
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
HbA1C [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
Fasting Blood Glucose [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus
Official Title  ICMJE Umbilical Cord Mesenchymal Stem Cell Infusion With Liraglutide in Type 2 Diabetes Mellitus
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: GLP-1
    GLP-1 therapy
  • Biological: SC
    Stem cell infusion
  • Other: Standard Medical Treatment
    Standard Medical Treatment
    Other Name: SMT
Study Arms  ICMJE
  • Experimental: SC-GLP-1
    Umbilical Cord Mesenchymal Stem Cell Infusion Combined With Liraglutide
    Interventions:
    • Drug: GLP-1
    • Biological: SC
    • Other: Standard Medical Treatment
  • Experimental: SC
    Umbilical Cord Mesenchymal Stem Cell Infusion
    Interventions:
    • Biological: SC
    • Other: Standard Medical Treatment
  • Experimental: GLP-1
    Liraglutide
    Interventions:
    • Drug: GLP-1
    • Other: Standard Medical Treatment
  • Active Comparator: Control
    Standard Medical Treatment
    Intervention: Other: Standard Medical Treatment
Publications * Chen P, Huang Q, Xu XJ, Shao ZL, Huang LH, Yang XZ, Guo W, Li CM, Chen C. [The effect of liraglutide in combination with human umbilical cord mesenchymal stem cells treatment on glucose metabolism and β cell function in type 2 diabetes mellitus]. Zhonghua Nei Ke Za Zhi. 2016 May 1;55(5):349-54. doi: 10.3760/cma.j.issn.0578-1426.2016.05.004. Chinese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 26, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01954147
Other Study ID Numbers  ICMJE SC/GLP-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Diabetes Care Center of Nanjing Military Command
Study Sponsor  ICMJE Diabetes Care Center of Nanjing Military Command
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiangjin Xu, Professor Diabetes Care Center of Nanjing Millitary Command
PRS Account Diabetes Care Center of Nanjing Military Command
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP