Diabetes Mellitus, Type 2Phase 4NCT03660683
Effect of Saxagliptin and Dapagliflozin on Endothelial Progenitor Cell in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Dapagliflozin 10mg and Saxagliptin 5mg in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Sabyasachi Sen at 1 site in United States.
Trial summary
The Investigator hypothesize that Dapagliflozin will improve EPC number and function AND Saxagliptin in addition to Dapagliflozin (additive effect) may improve EPC number and function even more than Dapa alone, compared to placebo. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- What is being tested?
- Dapagliflozin 10mg and Saxagliptin 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 10 Dec 2021
- 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
- Able to understand the study, and provide a signed \& dated informed consent.
- Diagnosis of Type 2 diabetes mellitus using criteria of the American Diabetes Association.
- 30-70 years old.
- HbA1C 7 to 10%, both inclusive
- BMI of 25 - 39.9 kg/m2 both inclusive.
- Taking a stable dose (for 12 weeks) of Metformin (any dosage) and/or Insulin (any dosage) for the treatment of T2DM
Show all 15Show fewer
- Patients with current Cardiovascular Disease (CVD) in tye 2 diabetes patients, defined by ≥ 1 of the following:
- MI >2 months prior
- Multivessel CAD
- Angina (intermittent or chronic)
- Single vessel CAD with positive stress test or UA hospitalization in prior year
- UA >2 months prior and evidence of CAD
- Stroke >2 months prior
- Occlusive PAD
- Proteinuria of more than 30mg/dl
Who cannot join
- Planned CV surgery or angioplasty in 1 month
- Prior surgery with chronic malabsorption (eg, bariatric) in prior 1 year
- Diagnosis of Type 1 diabetes mellitus
- History of GAD antibody positive status
- Uncontrolled Inflammatory Disease/Inflammatory drug use. Evaluated by PI on case-by-case basis
- Recent history of diabetic keto-acidosis in the past 3months, or recurrent history of diabetic ketoacidosis (≥ 3 times)
Show all 30Show fewer
- Active bladder cancer
- Active wounds (e.g. Diabetic ulcers) or recent surgery within 1 month
- Untreated hyper/hypothyroidism
- Women of child bearing potential who are not willing to use a contraceptive method to avoid pregnancy for the 16 weeks of study duration
- Women who are pregnant or breastfeeding
- Implanted devices (eg. Pacemaker) that may interact with Tanita scale
- Any other clinical condition that would jeopardize patients safety while participating in this clinical trial Concomitant Medications
- Taking any other oral anti-diabetic agent other than Metformin and/or Insulin for their treatment of T2DM
- Beginning statin medications in the past 1 month or change in statin dose in the past 1 month
- Use of consistent long-term steroid medication (oral, inhaled, injected) within the last 1 month
- Treatment with a strong cytochrome P450 3A4 (CYP34A) or P-gp inducer (ie. Rifampin)
- Subjects with a history of any serious hypersensitivity reaction to Dapagliflozin / Saxagliptin or another SGLT-2 inhibitor/ DPP4 inhibitor Laboratory Findings
- Uncontrolled hyperglycemia, defined as a fasting glucose >240 mg/dL (>13.3 mmol/L) at screening.
- Liver disease with ALT, AST or ALP x3 ULN
- eGFR < 60 mL/min/1.73 m2 by MDRD equation in the past 3 months
- Clinically significant RBC disorders such as hemoglobinopathies
- Serum creatinine levels ≥1.8 mg/dL with estimated eGFP < 60 mL/min
- Triglycerides > 450 mg/dL
- Baseline Hematuria (judged by a urinalysis dipstick at screening) Social History
- Active smokers
- Chronic or persistent alcohol or drug abuse
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg. infectious disease) illness
- Participation in another trial with an investigational drug within 30 days prior to informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: Cardio-Protective of Effect of Saxagliptin and Dapagliflozin Combination on Endothelial Progenitor Cells in Patients With Type 2 Diabetes
The Investigator hypothesize that Dapagliflozin will improve EPC number and function AND Saxagliptin in addition to Dapagliflozin (additive effect) may improve EPC number and function even more than Dapa alone, compared to placebo.
The Investigator propose a 3-arm randomized, parallel group, longitudinal study of 16-week intervention duration. Participants will be randomized to 3 groups:
Group A: Dapa (10 mg) + Saxa Placebo, Enroll n=15, retain n=12 Group B: Dapa (10 mg) + Saxa (5 mg), Enroll n=15, retain n=12 Group C: Dapa Placebo + Saxa Placebo, Enroll n=15, retain n=12
Read the detailed description
The Investigator hypothesize that Dapagliflozin will improve EPC number and function AND Saxagliptin in addition to Dapagliflozin may have an additive effect to improve EPC number and function even more than Dapa alone, compared to placebo.
In this proposal the investigator plan to conduct a placebo matched study with type 2 diabetes subjects on any doses of metformin or Insulin or a combination of both and has no history of DPP4 ( Dipeptidyl Peptidase-4) DPP4 inhibitor, incretin mimetic or SGLT2 inhibitor intake history. Participants will have known macrovascular complications (such as Cardiovascular Disease (CVD), Cerebrovascular Accident (CVA), and Peripheral Vascular Disease (PVD).
3 STUDY OBJECTIVES
PRIMARY OBJECTIVE:
CELLULAR BIOMARKER OF ENDOTHELIUM
The primary objective is to ascertain if 16 weeks of Dapa or Dapa+Saxa Combo therapy will improve :
CD34+ cell number, CD34+ migratory function and CD34+ gene expression in type 2 diabetes with CVD.
SECONDARY OBJECTIVE:
ARTERIAL STIFFNESS AND RENAL FUNCTION, NON-CELLULAR MARKERS OF ENDOTHELIUM To determine whether use of Dapa or Dapa+Saxa Combo alters markers of endothelial function such as: arterial stiffness measures (via tonometry), biochemical measures derived from plasma, pertaining to endothelial function (hs-CRP, IL-6, TNF-alpha), renal function such as proteinuria (microalbumin/creatinine ratio) and urine exosome study to determine podocyte health. The secondary measures are indirect measures of endothelial inflammation in early type 2 diabetes patients.
Effect on Arterial Stiffness:
- Pulse Wave Analysis and Vascular Flow will be assessed using SphygmoCor CP system from ATCOR as a measure of central arterial pressure and arterial stiffness.
II. Vessel health will be assessed by degree of arterial stiffness, using arterial tonometry.
III. The central and the aortic pressure is assessed by pulse wave analysis (PWA) and pulse wave velocity (PWV).
Effect on Blood Biochemistry:
The Investigator believes cell based biomarkers are superior to traditional serum and plasma biomarkers and the outcome report will be stronger if one can show positive correlation between the two outcome measures. The Investigator therefore will be looking at:
- Inflammation, apoptosis and anti-oxidant protein levels: Highly selective C-reactive protein (hs-CRP), IL-6, TNF-alpha.
II. Plasma SDF1 alpha (ELISA) and GLP-1 and Ghrelin (ELISA) will be estimated to assess endothelial health and factors that may influence CD34+ cell chemotaxis III. Podocyte health via urine exosome analysis. IV. The glomerular filtration rate (GFR) will be estimated by MDRD equation.
- GFR = 141 X min (Scr/κ,1)α X max(Scr/κ,1)-1.209 X 0.993Age X 1.018 [if female] X 1.159 [if African American]; where Scr is serum creatinine (mg/dL), κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.32
TERTIARY OBJECTIVE:
METABOLISM MARKERS The tertiary objective is to determine whether use of Dapa or Dapa+Saxa Combo alters body composition, fasting lipid profile, and levels of insulin, glucose, and appetite controlling hormones.
Effect on Blood Biochemistry:
The Investigator believes cell based biomarkers are superior to traditional serum and plasma biomarkers and the outcome report will be stronger if one can show positive co-relation between the two outcome measures.
- Fasting glucose, and insulin. a. Glycemic control will be evaluated by measuring fasting blood glucose, insulin levels and HbA1c. Fasting blood glucose, insulin and lipid profile will be used to assess insulin resistance.28,31 II. Lipid profile III. Appetite controlling hormones via LabCorp: Leptin, Adiponectin IV. Appetite controlling hormones, via ELISA: GLP1, Ghrelin
Effect of Dapa and Dapa+Saxa Combo on Body Habitus (Determination of body composition and visceral fat) The Investigator plans to study cardio-metabolic effect of Dapa and Dapa+Saxa Combo.
- Using body composition scale:
- Height and weight will be measured and the body mass index (BMI=kgm2) used as an indicator of relative weight.
- The body composition scale calculates body fat%, total body water%, fat free mass, etc., in addition to BMI. The secondary outcome markers (arterial stiffness and renal outcome measures) and tertiary outcome markers (serum biochemistry) are crucial in order to corroborate the cellular findings with currently accepted clinical efficacy outcome measures such as arterial stiffness and serum biochemistry. This design is similar to our recently published manuscript on Saxagliptin and cellular outcome measures. 4 INVESTIGATIONAL PLAN STUDY DESIGN AND DURATION +/- 6 day window for visits *Assessed at week 0, 8 and 16: Primary, Secondary \& Tertiary Outcomes. Week 20: A telephone call to subjects will be made 4 weeks after last dose of study medication to determine if there have been any adverse events.
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Being tested
- Dapagliflozin 10mg, Saxagliptin 5mg, Placebo Oral Tablet
- Keywords
- saxagliptin dapagliflozin diabetes cardiovascular diseases EPC
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mgDrug
Also called Farxiga
Dapagliflozin 10mg PO QD
Saxagliptin 5mgDrug
Also called Onglyza
Saxagliptin 5 mg PO QD
Placebo Oral TabletDrug
Also called Placebo
Matching Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| Group A Dapa | Experimental | Dapagliflozin 10 mg + Saxagliptin Placebo Receives: Drug: Dapagliflozin 10mg |
| Group B DapaSaxa | Active comparator | Dapagliflozin 10mg + Saxagliptin 5mg Receives: Drug: Dapagliflozin 10mg; Drug: Saxagliptin 5mg |
| Placebo | Placebo comparator | Placebo Oral Tablet Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD 34+ Cell Migratory Function
Proportion of cells that migrate through SDF1a in a transwell assay. This proportion is represented as a migratory rating scale from 0-1, with 1 being 100% of cells migrate. A larger value indicates better migratory function of the CD34+ cells.
Measured: 16 weeks
Secondary outcomes (8)
CD 34+ Cell Gene Expression
Fold change of Gene Expression in T2Dm with CVD relative to visit 1
Measured: 16 weeks from visit 1
CD 34+ Cell Fraction
Quantifying CD34+ cells is based on proportion of the monocytes that are CD34+ to account for any variations in cell harvesting or death during analysis.
Measured: 16 weeks
Arterial Stiffness - Augmentation Index
Augmentation index was calculated via tonometry with Sphygmocor Device (Pulse Wave Analysis). Augmentation index is calculated as the augmentation pressure (the amplitude of the reflected pulse wave) divided by the pulse pressure (systolic - diastolic) * 100 to give a percentage of pulse pressure. The software then calculates an estimated Augmentation Index at heart rate of 75 as a form of "normalization." Lower values are generally preferred as they indicate more pliable and healthy arteries.
Measured: 16 Weeks
Blood Biochemistries
hsCRP
Measured: 16 Weeks
Renal Function
Microalbumin/Creatinine Ratio (Proteinuria)
Measured: 16 Weeks
Urine Exosome Assay
Protein western analysis of Exosomes released from Kidney Podocyte is a indicator of kidney Podocyte health.
Expressed as a ratio normalized to CD9 expression
Measured: 16 Weeks
Arterial Stiffness
Pulse Wave Velocity
Measured: Week 16
Arterial Stiffness - Augmentation Pressure
Augmentation index was calculated via tonometry with Sphygmocor Device (Pulse Wave Analysis). Augmentation index is calculated as the augmentation pressure (the amplitude of the reflected pulse wave) divided by the pulse pressure (systolic - diastolic) * 100 to give a percentage of pulse pressure. The software then calculates an estimated Augmentation Index at heart rate of 75 as a form of "normalization." Lower values are generally preferred as they indicate more pliable and healthy arteries.
Here, augmentation pressure is shown as a reference for the Augmentation Index calculations in the previous section.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start22 Oct 2018
- Primary completion11 Mar 2021
- Study completion10 Dec 2021
Why it stopped: Sponsor did not want to continue funding the study
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 Diabetes Mellitus, Type 2Studies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sabyasachi Sen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sabyasachi Sen, George Washington University
- Investigators
- Sabyasachi Sen, MD, PhD, Principal investigator, GWU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660683
- Sponsor's protocol ID
- 180295
- Status last verified
- Jun 2023
- First submitted
- 17 Aug 2018
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nandula SR, Jain A, Sen S. Cardio-renal effect of dapagliflozin and dapagliflozin- saxagliptin combination on CD34 + ve hematopoietic stem cells (HSCs) and podocyte specific markers in type 2 diabetes (T2DM) subjects: a randomized trial. Stem Cell Res Ther. 2025 Jan 26;16(1):28. doi: 10.1186/s13287-025-04130-x.
PubMed 39865301
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-Protective of Effect of Saxagliptin and Dapagliflozin Combination on Endothelial Progenitor Cells in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03660683
- Acronym / sponsor ID
- 180295
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
- Keywords
- saxagliptin dapagliflozin diabetes cardiovascular diseases EPC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor did not want to continue funding the study
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sabyasachi SenUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 5 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Investigator hypothesize that Dapagliflozin will improve EPC number and function AND Saxagliptin in addition to Dapagliflozin (additive effect) may improve EPC number and function even more than Dapa alone, compared to placebo.
The Investigator propose a 3-arm randomized, parallel group, longitudinal study of 16-week intervention duration. Participants will be randomized to 3 groups:
Group A: Dapa (10 mg) + Saxa Placebo, Enroll n=15, retain n=12 Group B: Dapa (10 mg) + Saxa (5 mg), Enroll n=15, retain n=12 Group C: Dapa Placebo + Saxa Placebo, Enroll n=15, retain n=12
Detailed description
The Investigator hypothesize that Dapagliflozin will improve EPC number and function AND Saxagliptin in addition to Dapagliflozin may have an additive effect to improve EPC number and function even more than Dapa alone, compared to placebo.
In this proposal the investigator plan to conduct a placebo matched study with type 2 diabetes subjects on any doses of metformin or Insulin or a combination of both and has no history of DPP4 ( Dipeptidyl Peptidase-4) DPP4 inhibitor, incretin mimetic or SGLT2 inhibitor intake history. Participants will have known macrovascular complications (such as Cardiovascular Disease (CVD), Cerebrovascular Accident (CVA), and Peripheral Vascular Disease (PVD).
3 STUDY OBJECTIVES
PRIMARY OBJECTIVE:
CELLULAR BIOMARKER OF ENDOTHELIUM
The primary objective is to ascertain if 16 weeks of Dapa or Dapa+Saxa Combo therapy will improve :
CD34+ cell number, CD34+ migratory function and CD34+ gene expression in type 2 diabetes with CVD.
SECONDARY OBJECTIVE:
ARTERIAL STIFFNESS AND RENAL FUNCTION, NON-CELLULAR MARKERS OF ENDOTHELIUM To determine whether use of Dapa or Dapa+Saxa Combo alters markers of endothelial function such as: arterial stiffness measures (via tonometry), biochemical measures derived from plasma, pertaining to endothelial function (hs-CRP, IL-6, TNF-alpha), renal function such as proteinuria (microalbumin/creatinine ratio) and urine exosome study to determine podocyte health. The secondary measures are indirect measures of endothelial inflammation in early type 2 diabetes patients.
Effect on Arterial Stiffness:
- Pulse Wave Analysis and Vascular Flow will be assessed using SphygmoCor CP system from ATCOR as a measure of central arterial pressure and arterial stiffness.
II. Vessel health will be assessed by degree of arterial stiffness, using arterial tonometry.
III. The central and the aortic pressure is assessed by pulse wave analysis (PWA) and pulse wave velocity (PWV).
Effect on Blood Biochemistry:
The Investigator believes cell based biomarkers are superior to traditional serum and plasma biomarkers and the outcome report will be stronger if one can show positive correlation between the two outcome measures. The Investigator therefore will be looking at:
- Inflammation, apoptosis and anti-oxidant protein levels: Highly selective C-reactive protein (hs-CRP), IL-6, TNF-alpha.
II. Plasma SDF1 alpha (ELISA) and GLP-1 and Ghrelin (ELISA) will be estimated to assess endothelial health and factors that may influence CD34+ cell chemotaxis III. Podocyte health via urine exosome analysis. IV. The glomerular filtration rate (GFR) will be estimated by MDRD equation.
- GFR = 141 X min (Scr/κ,1)α X max(Scr/κ,1)-1.209 X 0.993Age X 1.018 [if female] X 1.159 [if African American]; where Scr is serum creatinine (mg/dL), κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.32
TERTIARY OBJECTIVE:
METABOLISM MARKERS The tertiary objective is to determine whether use of Dapa or Dapa+Saxa Combo alters body composition, fasting lipid profile, and levels of insulin, glucose, and appetite controlling hormones.
Effect on Blood Biochemistry:
The Investigator believes cell based biomarkers are superior to traditional serum and plasma biomarkers and the outcome report will be stronger if one can show positive co-relation between the two outcome measures.
- Fasting glucose, and insulin. a. Glycemic control will be evaluated by measuring fasting blood glucose, insulin levels and HbA1c. Fasting blood glucose, insulin and lipid profile will be used to assess insulin resistance.28,31 II. Lipid profile III. Appetite controlling hormones via LabCorp: Leptin, Adiponectin IV. Appetite controlling hormones, via ELISA: GLP1, Ghrelin
Effect of Dapa and Dapa+Saxa Combo on Body Habitus (Determination of body composition and visceral fat) The Investigator plans to study cardio-metabolic effect of Dapa and Dapa+Saxa Combo.
- Using body composition scale:
- Height and weight will be measured and the body mass index (BMI=kgm2) used as an indicator of relative weight.
- The body composition scale calculates body fat%, total body water%, fat free mass, etc., in addition to BMI. The secondary outcome markers (arterial stiffness and renal outcome measures) and tertiary outcome markers (serum biochemistry) are crucial in order to corroborate the cellular findings with currently accepted clinical efficacy outcome measures such as arterial stiffness and serum biochemistry. This design is similar to our recently published manuscript on Saxagliptin and cellular outcome measures. 4 INVESTIGATIONAL PLAN STUDY DESIGN AND DURATION +/- 6 day window for visits *Assessed at week 0, 8 and 16: Primary, Secondary \& Tertiary Outcomes. Week 20: A telephone call to subjects will be made 4 weeks after last dose of study medication to determine if there have been any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A Dapa | Experimental | Drug: Dapagliflozin 10mgDapagliflozin 10 mg + Saxagliptin Placebo |
| Group B DapaSaxa | Active comparator | Drug: Dapagliflozin 10mg, Drug: Saxagliptin 5mgDapagliflozin 10mg + Saxagliptin 5mg |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo Oral Tablet |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Able to understand the study, and provide a signed \& dated informed consent.
- Diagnosis of Type 2 diabetes mellitus using criteria of the American Diabetes Association.
- 30-70 years old.
- HbA1C 7 to 10%, both inclusive
- BMI of 25 - 39.9 kg/m2 both inclusive.
Key exclusion criteria (30 listed)
- Planned CV surgery or angioplasty in 1 month
- Prior surgery with chronic malabsorption (eg, bariatric) in prior 1 year
- Diagnosis of Type 1 diabetes mellitus
- History of GAD antibody positive status
- Uncontrolled Inflammatory Disease/Inflammatory drug use. Evaluated by PI on case-by-case basis
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 |
|---|---|---|
| Dapagliflozin 10mgAlso: FarxigaDapagliflozin 10mg PO QD | Drug | Group A Dapa, Group B DapaSaxa |
| Saxagliptin 5mgAlso: OnglyzaSaxagliptin 5 mg PO QD | Drug | Group B DapaSaxa |
| Placebo Oral TabletAlso: PlaceboMatching Placebo Tablets | Drug | Placebo |
Primary outcome
CD 34+ Cell Migratory Function
Time frame: 16 weeks
Proportion of cells that migrate through SDF1a in a transwell assay. This proportion is represented as a migratory rating scale from 0-1, with 1 being 100% of cells migrate. A larger value indicates better migratory function of the CD34+ cells.
8 secondary outcomes
CD 34+ Cell Gene Expression
Time frame: 16 weeks from visit 1
CD 34+ Cell Fraction
Time frame: 16 weeks
Arterial Stiffness - Augmentation Index
Time frame: 16 Weeks
Blood Biochemistries
Time frame: 16 Weeks
Renal Function
Time frame: 16 Weeks
Urine Exosome Assay
Time frame: 16 Weeks
Arterial Stiffness
Time frame: Week 16
Arterial Stiffness - Augmentation Pressure
Time frame: 16 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39865301Nandula SR, Jain A, Sen S. Cardio-renal effect of dapagliflozin and dapagliflozin- saxagliptin combination on CD34 + ve hematopoietic stem cells (HSCs) and podocyte specific markers in type 2 diabetes (T2DM) subjects: a randomized trial. Stem Cell Res Ther. 2025 Jan 26;16(1):28. doi: 10.1186/s13287-025-04130-x.
- Individual participant dataSharing planned: Undecided
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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
GWU
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 Dapagliflozin 10mg and Saxagliptin 5mg in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Sabyasachi Sen 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 15 inclusion and 30 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: stopped early, as of the sponsor's last update on 5 Jun 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 5 Jun 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?
CD 34+ Cell Migratory Function (time frame: 16 weeks). 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 NCT03660683, 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 5 Jun 2023.