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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: GLP-1 Biological: SC Other: Standard Medical Treatment Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Umbilical Cord Mesenchymal Stem Cell Infusion With Liraglutide in Type 2 Diabetes Mellitus
Study Start Date : October 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: SC-GLP-1
Umbilical Cord Mesenchymal Stem Cell Infusion Combined With Liraglutide
 Drug: GLP-1
GLP-1 therapy

Biological: SC
Stem cell infusion

Other: Standard Medical Treatment
Standard Medical Treatment
Other Name: SMT
Experimental: SC
Umbilical Cord Mesenchymal Stem Cell Infusion
 Biological: SC
Stem cell infusion

Other: Standard Medical Treatment
Standard Medical Treatment
Other Name: SMT
Experimental: GLP-1
Liraglutide
 Drug: GLP-1
GLP-1 therapy

Other: Standard Medical Treatment
Standard Medical Treatment
Other Name: SMT
Active Comparator: Control
Standard Medical Treatment
 Other: Standard Medical Treatment
Standard Medical Treatment
Other Name: SMT


Outcome Measures
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Primary Outcome Measures :
  1. HbA1C [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Fasting Blood Glucose [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) .
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954147


Locations
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China, Fujian
Diabetes Care Center of Nanjing Military Command
Fuzhou, Fujian, China, 350025
Sponsors and Collaborators
Diabetes Care Center of Nanjing Military Command
Investigators
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Principal Investigator: Xiangjin Xu, Professor Diabetes Care Center of Nanjing Millitary Command
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Diabetes Care Center of Nanjing Military Command
ClinicalTrials.gov Identifier: NCT01954147    
Other Study ID Numbers: SC/GLP-1
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases