Type 2 DiabetesPhase 1/2NCT01954147
Umbilical Cord Mesenchymal Stem Cells and Liraglutide in Diabetes Mellitus
A Phase 1/2 study testing GLP-1, SC and Standard Medical Treatment in people with Type 2 Diabetes, run by Diabetes Care Center of Nanjing Military Command at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- GLP-1, SC and Standard Medical Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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/㎡
Who cannot join
- 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.
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- 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) .
Trial locations and contacts
1 site in 1 country.
China1 site
Diabetes Care Center of Nanjing Military Command
Fuzhou, Fujian, 350025
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes
- Being tested
- GLP-1, SC, Standard Medical Treatment
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Drug
GLP-1 therapy
SCBiological
Stem cell infusion
Standard Medical TreatmentOther
Also called SMT
Standard Medical Treatment
| Study group | Role | What they receive |
|---|---|---|
| SC-GLP-1 | Experimental | Umbilical Cord Mesenchymal Stem Cell Infusion Combined With Liraglutide Receives: Drug: GLP-1; Biological: SC; Other: Standard Medical Treatment |
| SC | Experimental | Umbilical Cord Mesenchymal Stem Cell Infusion Receives: Biological: SC; Other: Standard Medical Treatment |
| GLP-1 | Experimental | Liraglutide Receives: Drug: GLP-1; Other: Standard Medical Treatment |
| Control | Active comparator | Standard Medical Treatment Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Measured: 1 year
Secondary outcomes (1)
Fasting Blood Glucose
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Care Center of Nanjing Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangjin Xu, Professor, Principal investigator, Diabetes Care Center of Nanjing Millitary Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954147
- Sponsor's protocol ID
- SC/GLP-1
- Status last verified
- Feb 2014
- First submitted
- 13 Aug 2013
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 beta 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.
PubMed 27143183
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Mesenchymal Stem Cell Infusion With Liraglutide in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01954147
- Acronym / sponsor ID
- SC/GLP-1
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Diabetes Care Center of Nanjing Military CommandUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SC-GLP-1 | Experimental | Drug: GLP-1, Biological: SC, Other: Standard Medical TreatmentUmbilical Cord Mesenchymal Stem Cell Infusion Combined With Liraglutide |
| SC | Experimental | Biological: SC, Other: Standard Medical TreatmentUmbilical Cord Mesenchymal Stem Cell Infusion |
| GLP-1 | Experimental | Drug: GLP-1, Other: Standard Medical TreatmentLiraglutide |
| Control | Active comparator | Other: Standard Medical TreatmentStandard Medical Treatment |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1GLP-1 therapy | Drug | GLP-1, SC-GLP-1 |
| SCStem cell infusion | Biological | SC, SC-GLP-1 |
| Standard Medical TreatmentAlso: SMTStandard Medical Treatment | Other | Control, GLP-1, SC, SC-GLP-1 |
Primary outcome
HbA1C
Time frame: 1 year
1 secondary outcome
Fasting Blood Glucose
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2014.
- Derived from this study: PubMed 27143183Chen 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 beta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangjin Xu, Professor principal investigator
Diabetes Care Center of Nanjing Millitary Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GLP-1, SC and Standard Medical Treatment in people with Type 2 Diabetes, run by Diabetes Care Center of Nanjing Military Command at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01954147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2014.