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Effect of Saxagliptin and Dapagliflozin on Endothelial Progenitor Cell in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03660683
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Sabyasachi Sen, George Washington University

Brief 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.

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


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Cardiovascular Diseases Drug: Dapagliflozin 10mg Drug: Saxagliptin 5mg Drug: Placebo Oral Tablet Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cardio-Protective of Effect of Saxagliptin and Dapagliflozin Combination on Endothelial Progenitor Cells in Patients With Type 2 Diabetes
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A Dapa
Dapagliflozin 10 mg + Saxagliptin Placebo
Drug: Dapagliflozin 10mg
Dapagliflozin 10mg PO QD
Other Name: Farxiga

Active Comparator: Group B DapaSaxa
Dapagliflozin 10mg + Saxagliptin 5mg
Drug: Dapagliflozin 10mg
Dapagliflozin 10mg PO QD
Other Name: Farxiga

Drug: Saxagliptin 5mg
Saxagliptin 5 mg PO QD
Other Name: Onglyza

Placebo Comparator: Placebo
Placebo Oral Tablet
Drug: Placebo Oral Tablet
Matching Placebo Tablets
Other Name: Placebo




Primary Outcome Measures :
  1. CD 34+ Cell Number [ Time Frame: 16 weeks ]
    Cluster Designation 34+ Cell Number

  2. CD 34+ Cell Migratory Function [ Time Frame: 16 weeks ]
    Cell Migration throught SDF1a

  3. CD 34+ Cell Gene Expression in T2Dm with CVD [ Time Frame: 16 weeks ]
    Gene Expression


Secondary Outcome Measures :
  1. Arterial Stiffness [ Time Frame: 16 Weeks ]
    via tonometry

  2. Blood Biochemistries [ Time Frame: 16 Weeks ]
    hs CRP, IL6, TNFa

  3. Renal Function [ Time Frame: 16 Weeks ]
    Micro albumin/ Creatinine Ratio ( Proteinuria)

  4. Urine Exosome Assay [ Time Frame: 16 Weeks ]
    Exosomes released from Kidney Podocyte is a indicator of kidney Podocyte health.


Other Outcome Measures:
  1. Body Fat Percent [ Time Frame: 16 Weeks ]
    using Tanita B350 Total Body Composition Analyzer

  2. Fasting Lipid Profile [ Time Frame: 16 Weeks ]
    Total Cholesterol, LDL, HDL and VLDL

  3. Serum Insulin Level [ Time Frame: 16 Weeks ]
  4. Serum Glucose [ Time Frame: 16 Weeks ]
    HbA1c, Fasting Glucose

  5. Appetite Controlling Hormone [ Time Frame: 16 Weeks ]
    Leptin, Adiponectin, GLP1, Ghrelin



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to understand the study, and provide a signed & dated informed consent.
  2. Diagnosis of Type 2 diabetes mellitus using criteria of the American Diabetes Association.
  3. 30-70 years old.
  4. HbA1C 7 to 10%, both inclusive
  5. BMI of 25 - 39.9 kg/m2 both inclusive.
  6. Taking a stable dose (for 12 weeks) of Metformin (any dosage) and/or Insulin (any dosage) for the treatment of T2DM
  7. Patients with current Cardiovascular Disease (CVD) in tye 2 diabetes patients, defined by ≥ 1 of the following:

    1. MI >2 months prior
    2. Multivessel CAD
    3. Angina (intermittent or chronic)
    4. Single vessel CAD with positive stress test or UA hospitalization in prior year
    5. UA >2 months prior and evidence of CAD
    6. Stroke >2 months prior
    7. Occlusive PAD
    8. Proteinuria of more than 30mg/dl

Exclusion Criteria:

  1. Planned CV surgery or angioplasty in 1 month
  2. Prior surgery with chronic malabsorption (eg, bariatric) in prior 1 year
  3. Diagnosis of Type 1 diabetes mellitus
  4. History of GAD antibody positive status
  5. Uncontrolled Inflammatory Disease/Inflammatory drug use. **Evaluated by PI on case-by-case basis**
  6. Recent history of diabetic keto-acidosis in the past 3months, or recurrent history of diabetic ketoacidosis (≥ 3 times)
  7. Active bladder cancer
  8. Active wounds (e.g. Diabetic ulcers) or recent surgery within 1 month
  9. Untreated hyper/hypothyroidism
  10. Women of child bearing potential who are not willing to use a contraceptive method to avoid pregnancy for the 16 weeks of study duration
  11. Women who are pregnant or breastfeeding
  12. Implanted devices (eg. Pacemaker) that may interact with Tanita scale
  13. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial Concomitant Medications
  14. Taking any other oral anti-diabetic agent other than Metformin and/or Insulin for their treatment of T2DM
  15. Beginning statin medications in the past 1 month or change in statin dose in the past 1 month
  16. Use of consistent long-term steroid medication (oral, inhaled, injected) within the last 1 month
  17. Treatment with a strong cytochrome P450 3A4 (CYP34A) or P-gp inducer (ie. Rifampin)
  18. Subjects with a history of any serious hypersensitivity reaction to Dapagliflozin / Saxagliptin or another SGLT-2 inhibitor/ DPP4 inhibitor Laboratory Findings
  19. Uncontrolled hyperglycemia, defined as a fasting glucose >240 mg/dL (>13.3 mmol/L) at screening.
  20. Liver disease with ALT, AST or ALP x3 ULN
  21. eGFR < 60 mL/min/1.73 m2 by MDRD equation in the past 3 months
  22. Clinically significant RBC disorders such as hemoglobinopathies
  23. Serum creatinine levels ≥1.8 mg/dL with estimated eGFP < 60 mL/min
  24. Triglycerides > 450 mg/dL
  25. Baseline Hematuria (judged by a urinalysis dipstick at screening) Social History
  26. Active smokers
  27. Chronic or persistent alcohol or drug abuse
  28. Prisoners or subjects who are involuntarily incarcerated
  29. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg. infectious disease) illness
  30. Participation in another trial with an investigational drug within 30 days prior to informed consent

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): NCT03660683


Contacts
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Contact: Hassan Awal, MD 202 741 2389 hawal@mfa.gwu.edu

Locations
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United States, District of Columbia
The GW Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact: Hassan Awal, MD       hawal@mfa.gwu.edu   
Sponsors and Collaborators
Sabyasachi Sen
Investigators
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Principal Investigator: Sabyasachi Sen, MD, PhD GWU

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Responsible Party: Sabyasachi Sen, Associate Professor, Dept. of Medicine (Division of Endocrinology), George Washington University
ClinicalTrials.gov Identifier: NCT03660683     History of Changes
Other Study ID Numbers: 180295
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Sabyasachi Sen, George Washington University:
saxagliptin dapagliflozin diabetes cardiovascular diseases EPC

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Saxagliptin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors