Type 2 DiabetesPhase 4NCT02467478
Linagliptin's Effect on CD34+ Stem Cells
A Phase 4 study testing Linagliptin in people with Type 2 Diabetes and Impaired Renal Function, run by George Washington University at 1 site in United States.
Trial summary
Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels which may contribute to heart disease. Endothelial Progenitor Cells (EPCs) are found in the blood. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Impaired Renal Function
- What is being tested?
- Linagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 30-70 years
- Diagnosis of type 2 diabetes within the previous 15 years using criteria of the American Diabetes Association
- Currently being treated with 1-2 grams/day of metformin, or insulin or both stably
- Hemoglobin A1c (HbA1C) between 6.5% to 10.0% (both inclusive)
- Body Mass Index (BMI) between 25 and 39.9 kg/m2 (both inclusive)
- Chronic Kidney disease (CKD) Stages 1-3, Creatinine clearance (CrCl) less than 90 and more than 29
Who cannot join
- Type 1 diabetes
- History of Diabetic Ketoacidosis (DKA) or hyperosmolar nonketotic coma
- Hemoglobinopathies with low hematocrit (Below 28 Units)
- History of pancreatitis
- History of cancer within the past 5 years (except basal cell carcinoma)
- Previous cardiovascular or cerebrovascular event within 6 months of screening or active or clinically significant coronary and/or Peripheral Vascular Disease (PVD)
Show all 25Show fewer
- Statin use started in the last 3 month
- Current use of oral or injectable anti-diabetic medication other than Metformin and insulin
- Consistent use of steroids within the last 3 months
- Any active wounds, or surgery within the past 3 months
- Inflammatory disease, or the chronic use of anti-inflammatory drugs within the past 3 months
- Untreated hyper/hypothyroidism
- Contraindications to moderate exercise
- Implanted devices that might interact with the tanita scale
- Pre-existing liver disease and/or Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) > 2.5 times Under the Normal Limits (UNL)
- Untreated Systolic blood pressure > 140 mmHg or diastolic blood pressure> 90 mmHg
- Serum creatinine levels ≥ 2.0
- CKD Stages 4 and 5 (estimated CrCl <30 mL/min)
- Triglycerides > 450 mg/dL
- Known allergies or hypersensitivities to Linagliptin or Dipeptidyl peptidase-4 (DDP-4) inhibitors
- Treatment with cytochrome p450 (CYP 3A4) inhibitors
- Women of child bearing age who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
- Prisoners or subjects that are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
- Additionally, patients who are active smokers, patients who are pregnant, nursing women, and post-menopausal women who are on hormone replacement therapy will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: Role of Linagliptin in Improving Renal Failure by Improving CD34+ Stem Cell Number, Function and Gene Expression in Renal Function Impaired Type 2 Diabetes Patients.
Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels which may contribute to heart disease. Endothelial Progenitor Cells (EPCs) are found in the blood. Research has shown that improving the survival of these special blood cells may decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart disease. Linagliptin is an Food and Drug Administration (FDA) approved prescription medicine used along with insulin or with oral medications to lower blood sugar in people with Type 2 diabetes. It is in a class of diabetes medication called Dipeptidyl peptidase-4 (DPP-4) inhibitors. DPP-4 inhibitors have been shown to increase EPCs in patients with Type 2 diabetes.
Hypothesis: Both type 2 diabetes and Chronic Kidney Disease (CKD) are associated with poor stem cell number and function. Poor viability and function of EPCs in CKD and diabetes The investigators hypothesize that use of Linagliptin (along with Insulin) may help reduce cardiovascular risk by improving EPC survival and function above and beyond adequate glucose metabolism control
Read the detailed description
Type 2 diabetes is a national epidemic with significant macro and microvascular complications. Insulin resistance in pre-diabetes and overt diabetes are associated with endothelial dysfunction.
A few studies indicate that stem cells particularly EPCs can act as a suitable bio-marker for monitoring cardiovascular morbidity. In this proposal the investigators suggest that EPCs or CD34 positive cells (defined as CD34/vascular endothelial growth factor receptor 2 (VEGFR2+) cells) can act as a suitable cellular biomarker for estimating and following endothelial dysfunction in early type 2 diabetes patients with CKD. EPCs have been shown to be dysfunctional in both CKD patients and type 2 Diabetes Mellitus (DM) patients.
Linagliptin (TRADJENTA) tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. No dose adjustment is recommended for patients with renal impairment.
EPCs have been used as a regenerative tool in ischemic myocardium and diabetic wound healing. Endothelial dysfunction with associated inflammation may be a consequence of excess intra-cellular super-oxide presence in a setting of diabetes which is a pro-oxidative stress condition ultimately leading to poor EPC function and senescence.
Though lifestyle modification has been proposed as a main stay for prevention and treatment of early type 2 diabetes, several new therapies for diabetes have been developed in recent years. Incretins and incretin mimetics appear to hold promise. Mechanism of positive effect of exercise and oral hypoglycemic agents can be very different.
DPP-4 inhibitors have been shown to increase EPCs in patients with type 2 diabetes reportedly via stromal cell-derived factor 1 (SDF-1) alpha up-regulation. Interestingly, up-regulation of SDF-1 alpha and vascular endothelial growth factor (VEGF), both chemotactic factors increase mobilization and recruitment of EPCs in the face of acute ischemic injury for repair and regeneration.
Several studies have shown positive effect of incretins (Glucagon like peptide, GLP-1) and incretin receptor agonists (GLP-1 receptor agonists) on cardiovascular risk factors in type 2 diabetes patients and even in patients with chronic heart failure and left ventricular dysfunction who do not have diabetes.
DPP-4 Inhibitors may have cardio-protective effects of their own, as they increase bio-availability of endogenous GLP-1. They improve blood flow and nitric oxide production in endothelium. These are unique properties not demonstrated by other oral diabetes medications. The mechanism underlying these effects may be mediated by increased nitric oxide bioavailability but is not completely known. However these beneficial effects appear to be independent of glycemia reduction.
It is however unknown whether Linagliptin will have any positive effect on human EPC function where two prominent cardiovascular risk factors co-exist such as CKD and type 2 diabetes.
Therefore the investigators plan to investigate if Linagliptin can alter function and gene expression of CD34+ cells in a setting of CKD and type 2 diabetes. The investigators choose to look at non geriatric adult population with early type 2 diabetes (less than 10 years of duration) at an early phase of renal impairment (stages 1-3).
- Conditions
- Type 2 Diabetes, Impaired Renal Function
- Being tested
- Linagliptin, Placebo
- Keywords
- Diabetes Mellitus, Type 2, Endothelial cells, Cellular biomarker, endothelial dysfunction, CD34+, Impaired renal function
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinagliptinDrug
Also called TRADJENTA
5 mg tablet once daily for 12 weeks
PlaceboDrug
1 tablet daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo 1 pill daily for 12 weeks Receives: Drug: Placebo |
| Linagliptin | Active comparator | Linagliptin 5mg once daily for 12 weeks Receives: Drug: Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular Markers
The investigators will use participants' peripheral blood derived CD34+ cells looking at number, function, and gene expression. Post Linagliptin will be compared to pre Linagliptin measurements. Here we report fold changes in protein populations as determined by ELISA.
Measured: Week 12 expression as a fold difference to Week 0
Urinary Function Marker in CKD
We measure using microalbumin/creatinine ratio provided from a random spot urine sample.
Measured: 12 weeks post beginning Linagliptin or placebo treatment
Secondary outcomes (11)
Serum Endothelial Inflammatory Markers
Serum endothelial inflammatory markers included here: high sensitivity C-reactive protein (hs-CRP)
Measured: 12 weeks post Linagliptin or Placebo treatment
Serum Endothelial Inflammatory Markers
Serum endothelial inflammatory markers included here: Interleukin 6 (IL-6)
Measured: 12 weeks post Linagliptin or Placebo treatment
Fasting Lipid Profile
Measured through serum biochemistry Lipid Panel
Measured: 12 weeks post beginning Linagliptin or placebo treatment
Glycemic Control
Glycemic control is evaluated by measuring HbA1c levels to gauge changes in blood sugar control over last ~90 days
Measured: 12 weeks post beginning Linagliptin or placebo treatment
Glycemic Control: Fasting Glucose
Glycemic control is evaluated by measuring fasting blood glucose at time of measurement
Measured: 12 weeks post beginning Linagliptin or placebo treatment
Glycemic Control: Insulin
Glycemic control is evaluated by measuring insulin levels at the time of the visit
Measured: 12 weeks post beginning Linagliptin or placebo treatment
Adiposity
Measured using the Tanita Body Composition Analyzer scale, measured as percentage body fat.
Measured: 12 weeks post beginning Linagliptin or placebo treatment
Estimation of Creatinine Clearance
Measured via blood biochemistry eGFR, an alternative measurement to spot urine urine microalbumin/creatinine ratio presented above
Measured: 12 weeks post beginning Linagliptin or placebo treatment
Pulse Wave Analysis
Vessel health is assessed by looking at Arterial stiffness. Augmentation index (AI) is defined as the ratio of the augmentation pressure to the pulse pressure, times 100, to give a percentage. Augmentation index 75 normalizes this value to an estimate of the AI at a heart rate of 75bpm. We used Vascular Flow and wave measurement equipment, SphygmoCor Central Pressure system from AtCor.
Measured: 12 weeks post beginning Linagliptin or placebo treatment
Pulse Wave Velocity
Vessel health is assessed by looking at Arterial stiffness. Pulse wave velocity (PWV) measures the delay between the pulse registered at the femoral artery from the pulse at the carotid. The difference in distance between these two measurement points from the aortic notch is divided by this delay to give a speed. In stiffer, less healthy vessels, the PWV is increased. We used Vascular Flow and wave measurement equipment, SphygmoCor Central Pressure system from AtCor to perform this calculation.
Measured: 12 weeks post beginning Linagliptin or placebo treatment
Resting Metabolic Rate (RMR)
(RMR, similar to Resting Energy expenditure measurement): Evaluation of changes in Basal Metabolic Rate
Measured: 12 weeks post beginning Linagliptin or placebo treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Sabyasachi Sen, George Washington University
- Investigators
- Sabyasachi Sen, MD, PhD, Principal investigator, Medical Faculty Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467478
- Sponsor's protocol ID
- 121439
- Status last verified
- Dec 2022
- First submitted
- 8 Jun 2015
- Last updated
- 19 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share IPD with other researchers.
Publications
Awal HB, Nandula SR, Domingues CC, Dore FJ, Kundu N, Brichacek B, Fakhri M, Elzarki A, Ahmadi N, Safai S, Fosso M, Amdur RL, Sen S. Linagliptin, when compared to placebo, improves CD34+ve endothelial progenitor cells in type 2 diabetes subjects with chronic kidney disease taking metformin and/or insulin: a randomized controlled trial. Cardiovasc Diabetol. 2020 Jun 3;19(1):72. doi: 10.1186/s12933-020-01046-z.
PubMed 32493344
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Linagliptin in Improving Renal Failure by Improving CD34+ Stem Cell Number, Function and Gene Expression in Renal Function Impaired Type 2 Diabetes Patients.
- ClinicalTrials.gov ID
- NCT02467478
- Acronym / sponsor ID
- 121439
- Conditions
- Type 2 Diabetes, Impaired Renal Function
- Keywords
- Diabetes Mellitus, Type 2, Endothelial cells, Cellular biomarker, endothelial dysfunction, CD34+, Impaired renal function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Posted 19 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 diabetes is a national epidemic. Diabetes has undesirable effects on blood vessels which may contribute to heart disease. Endothelial Progenitor Cells (EPCs) are found in the blood. Research has shown that improving the survival of these special blood cells may decrease the harmful effects of diabetes on blood vessels and reduce or reverse heart disease. Linagliptin is an Food and Drug Administration (FDA) approved prescription medicine used along with insulin or with oral medications to lower blood sugar in people with Type 2 diabetes. It is in a class of diabetes medication called Dipeptidyl peptidase-4 (DPP-4) inhibitors. DPP-4 inhibitors have been shown to increase EPCs in patients with Type 2 diabetes.
Hypothesis: Both type 2 diabetes and Chronic Kidney Disease (CKD) are associated with poor stem cell number and function. Poor viability and function of EPCs in CKD and diabetes The investigators hypothesize that use of Linagliptin (along with Insulin) may help reduce cardiovascular risk by improving EPC survival and function above and beyond adequate glucose metabolism control
Detailed description
Type 2 diabetes is a national epidemic with significant macro and microvascular complications. Insulin resistance in pre-diabetes and overt diabetes are associated with endothelial dysfunction.
A few studies indicate that stem cells particularly EPCs can act as a suitable bio-marker for monitoring cardiovascular morbidity. In this proposal the investigators suggest that EPCs or CD34 positive cells (defined as CD34/vascular endothelial growth factor receptor 2 (VEGFR2+) cells) can act as a suitable cellular biomarker for estimating and following endothelial dysfunction in early type 2 diabetes patients with CKD. EPCs have been shown to be dysfunctional in both CKD patients and type 2 Diabetes Mellitus (DM) patients.
Linagliptin (TRADJENTA) tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. No dose adjustment is recommended for patients with renal impairment.
EPCs have been used as a regenerative tool in ischemic myocardium and diabetic wound healing. Endothelial dysfunction with associated inflammation may be a consequence of excess intra-cellular super-oxide presence in a setting of diabetes which is a pro-oxidative stress condition ultimately leading to poor EPC function and senescence.
Though lifestyle modification has been proposed as a main stay for prevention and treatment of early type 2 diabetes, several new therapies for diabetes have been developed in recent years. Incretins and incretin mimetics appear to hold promise. Mechanism of positive effect of exercise and oral hypoglycemic agents can be very different.
DPP-4 inhibitors have been shown to increase EPCs in patients with type 2 diabetes reportedly via stromal cell-derived factor 1 (SDF-1) alpha up-regulation. Interestingly, up-regulation of SDF-1 alpha and vascular endothelial growth factor (VEGF), both chemotactic factors increase mobilization and recruitment of EPCs in the face of acute ischemic injury for repair and regeneration.
Several studies have shown positive effect of incretins (Glucagon like peptide, GLP-1) and incretin receptor agonists (GLP-1 receptor agonists) on cardiovascular risk factors in type 2 diabetes patients and even in patients with chronic heart failure and left ventricular dysfunction who do not have diabetes.
DPP-4 Inhibitors may have cardio-protective effects of their own, as they increase bio-availability of endogenous GLP-1. They improve blood flow and nitric oxide production in endothelium. These are unique properties not demonstrated by other oral diabetes medications. The mechanism underlying these effects may be mediated by increased nitric oxide bioavailability but is not completely known. However these beneficial effects appear to be independent of glycemia reduction.
It is however unknown whether Linagliptin will have any positive effect on human EPC function where two prominent cardiovascular risk factors co-exist such as CKD and type 2 diabetes.
Therefore the investigators plan to investigate if Linagliptin can alter function and gene expression of CD34+ cells in a setting of CKD and type 2 diabetes. The investigators choose to look at non geriatric adult population with early type 2 diabetes (less than 10 years of duration) at an early phase of renal impairment (stages 1-3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo 1 pill daily for 12 weeks |
| Linagliptin | Active comparator | Drug: LinagliptinLinagliptin 5mg once daily for 12 weeks |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 30-70 years
- Diagnosis of type 2 diabetes within the previous 15 years using criteria of the American Diabetes Association
- Currently being treated with 1-2 grams/day of metformin, or insulin or both stably
- Hemoglobin A1c (HbA1C) between 6.5% to 10.0% (both inclusive)
- Body Mass Index (BMI) between 25 and 39.9 kg/m2 (both inclusive)
Key exclusion criteria (25 listed)
- Type 1 diabetes
- History of Diabetic Ketoacidosis (DKA) or hyperosmolar nonketotic coma
- Hemoglobinopathies with low hematocrit (Below 28 Units)
- History of pancreatitis
- History of cancer within the past 5 years (except basal cell carcinoma)
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 |
|---|---|---|
| LinagliptinAlso: TRADJENTA5 mg tablet once daily for 12 weeks | Drug | Linagliptin |
| Placebo1 tablet daily for 12 weeks | Drug | Placebo |
Primary outcome
Cellular Markers
Time frame: Week 12 expression as a fold difference to Week 0
The investigators will use participants' peripheral blood derived CD34+ cells looking at number, function, and gene expression. Post Linagliptin will be compared to pre Linagliptin measurements. Here we report fold changes in protein populations as determined by ELISA.
Urinary Function Marker in CKD
Time frame: 12 weeks post beginning Linagliptin or placebo treatment
We measure using microalbumin/creatinine ratio provided from a random spot urine sample.
11 secondary outcomes
Serum Endothelial Inflammatory Markers
Time frame: 12 weeks post Linagliptin or Placebo treatment
Serum Endothelial Inflammatory Markers
Time frame: 12 weeks post Linagliptin or Placebo treatment
Fasting Lipid Profile
Time frame: 12 weeks post beginning Linagliptin or placebo treatment
Glycemic Control
Time frame: 12 weeks post beginning Linagliptin or placebo treatment
Glycemic Control: Fasting Glucose
Time frame: 12 weeks post beginning Linagliptin or placebo treatment
Glycemic Control: Insulin
Time frame: 12 weeks post beginning Linagliptin or placebo treatment
Adiposity
Time frame: 12 weeks post beginning Linagliptin or placebo treatment
Estimation of Creatinine Clearance
Time frame: 12 weeks post beginning Linagliptin or placebo treatment
Pulse Wave Analysis
Time frame: 12 weeks post beginning Linagliptin or placebo treatment
Pulse Wave Velocity
Time frame: 12 weeks post beginning Linagliptin or placebo treatment
Resting Metabolic Rate (RMR)
Time frame: 12 weeks post beginning Linagliptin or placebo treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32493344Awal HB, Nandula SR, Domingues CC, Dore FJ, Kundu N, Brichacek B, Fakhri M, Elzarki A, Ahmadi N, Safai S, Fosso M, Amdur RL, Sen S. Linagliptin, when compared to placebo, improves CD34+ve endothelial progenitor cells in type 2 diabetes subjects with chronic kidney disease taking metformin and/or insulin: a randomized controlled trial. Cardiovasc Diabetol. 2020 Jun 3;19(1):72. doi: 10.1186/s12933-020-01046-z.
- Individual participant dataSharing planned: No. There is no current plan to share IPD with other researchers.
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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.
Sabyasachi Sen, MD, PhD principal investigator
Medical Faculty Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linagliptin in people with Type 2 Diabetes and Impaired Renal Function, run by George Washington University at 1 site in United States.
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 6 inclusion and 25 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: finished, as of the sponsor's last update on 19 Jan 2023. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cellular Markers (time frame: Week 12 expression as a fold difference to Week 0). The study lists 2 primary outcomes in all. 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 NCT02467478, 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 19 Jan 2023.