Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus

February 19, 2014 updated by: Diabetes Care Center of Nanjing Military Command

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Diabetes Care Center of Nanjing Military Command

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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) .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SC-GLP-1
Umbilical Cord Mesenchymal Stem Cell Infusion Combined With Liraglutide
Other: Standard Medical Treatment
Standard Medical Treatment
Other Names:
  • SMT
Drug: GLP-1
GLP-1 therapy
Biological: SC
Stem cell infusion
EXPERIMENTAL: SC
Umbilical Cord Mesenchymal Stem Cell Infusion
Other: Standard Medical Treatment
Standard Medical Treatment
Other Names:
  • SMT
Biological: SC
Stem cell infusion
EXPERIMENTAL: GLP-1
Liraglutide
Other: Standard Medical Treatment
Standard Medical Treatment
Other Names:
  • SMT
Drug: GLP-1
GLP-1 therapy
ACTIVE_COMPARATOR: Control
Standard Medical Treatment
Other: Standard Medical Treatment
Standard Medical Treatment
Other Names:
  • SMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1C
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting Blood Glucose
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diabetes Care Center of Nanjing Military Command

Investigators

  • Principal Investigator: Xiangjin Xu, Professor, Diabetes Care Center of Nanjing Millitary Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

October 1, 2014

Study Completion (ANTICIPATED)

October 1, 2015

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (ESTIMATE)

October 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC/GLP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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