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Effect of Saxagliptin on EPCs as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early T2DM Patients

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ClinicalTrials.gov Identifier: NCT02024477
Recruitment Status : Completed
First Posted : December 31, 2013
Results First Posted : January 29, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Sabyasachi Sen, George Washington University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Saxagliptin
Drug: Placebo
Enrollment 42
Recruitment Details Subjects were recruited from clinic of the Principle Investigator and Sub-Investigators involved in the trial. First patient was recruited on 26 Nov 2013, last patient was recruited on 24 May 2016.
Pre-assignment Details Screening period lasted 2 weeks. No wash-out or run-in periods were necessary.
Arm/Group Title Placebo Saxagliptin
Hide Arm/Group Description Placebo: 1 tablet daily for 12 weeks Saxagliptin: 5 mg tablet once daily for 12 weeks
Period Title: Overall Study
Started 21 21
Completed 21 21
Not Completed 0 0
Arm/Group Title Placebo Saxagliptin Total
Hide Arm/Group Description Placebo: 1 tablet daily for 12 weeks Saxagliptin: 5 mg tablet once daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
56.4  (8.5) 58.3  (5.7) 57.3  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
7
  33.3%
11
  52.4%
18
  42.9%
Male
14
  66.7%
10
  47.6%
24
  57.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
African American
13
  61.9%
15
  71.4%
28
  66.7%
White
6
  28.6%
5
  23.8%
11
  26.2%
Other
2
   9.5%
1
   4.8%
3
   7.1%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 21 participants 21 participants 42 participants
202.3  (38.7) 202.7  (24.5) 202.5  (31.6)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 21 participants 21 participants 42 participants
31.5  (4.8) 32.3  (4.2) 31.9  (4.5)
Duration of Diabetes Mellitus II  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
3.5  (1.8) 3.7  (2.4) 3.6  (2.1)
HBA1c  
Mean (Standard Deviation)
Unit of measure:  Mmol/mol
Number Analyzed 21 participants 21 participants 42 participants
6.6  (0.5) 7.0  (0.8) 6.8  (0.65)
Fasting Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/Dl
Number Analyzed 21 participants 21 participants 42 participants
114.8  (25) 127.4  (35.9) 121.1  (30.45)
eGFR  
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73
Number Analyzed 21 participants 21 participants 42 participants
93.7  (16.7) 98.9  (14.5) 96.3  (15.6)
1.Primary Outcome
Title CD34+ Endothelial Progenitor Cells Number
Time Frame Up to 12 weeks post saxagliptin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Saxagliptin
Hide Arm/Group Description:
Placebo: 1 tablet daily for 12 weeks
Saxagliptin: 5 mg tablet once daily for 12 weeks
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: % of Mononuclear Cells
2.0  (0.3) 2.8  (0.5)
2.Primary Outcome
Title CD 34+ Cell Function
Hide Description function of EPC cell as migration of CD34+ cells in response to SDF-1a ( 100 ng/mL). Results are expressed in fluorescence ratio between cells exposed to the chemotactic factor and cells exposed to chemo attractant-free media ( control) followed by lysis in presence of CyQuant GR dye.
Time Frame Up to 12 weeks post saxagliptin Up to 12 weeks post saxagliptin: Visit 1 at Baseline, Visit 2 at 6 weeks, and Visit 3 at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Saxagliptin
Hide Arm/Group Description:
Placebo: 1 tablet daily for 12 weeks
Saxagliptin: 5 mg tablet once daily for 12 weeks
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: Ratio
Visit 1 - Week 0 1.2  (0.1) 1.05  (0.06)
Visit 2 - Week 6 1.05  (0.15) 1.55  (0.2)
Visit 3 - Week 12 1.0  (0.06) 1.2  (0.05)
3.Secondary Outcome
Title Serum Endothelial Inflammatory Marker hsCRP
Hide Description [Not Specified]
Time Frame Baseline 6 and 12 weeks post saxagliptin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Saxagliptin
Hide Arm/Group Description:
Placebo: 1 tablet daily for 12 weeks
Saxagliptin: 5 mg tablet once daily for 12 weeks
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mg/L
Visit 1 - Baseline 2.4  (0.6) 2.8  (0.5)
Visit 2 - Week 6 2.9  (0.8) 2.7  (0.4)
Visit 3 - Week 12 2.9  (0.7) 2.4  (0.4)
4.Secondary Outcome
Title Fasting Lipid Profile LDL/HDL
Hide Description ratio of LDL over HDL
Time Frame Baseline, 6 and 12 weeks post saxagliptin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Saxagliptin
Hide Arm/Group Description:
Placebo: 1 tablet daily for 12 weeks
Saxagliptin: 5 mg tablet once daily for 12 weeks
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: ratio of LDL over HDL
Visit 1 - Baseline 2.3  (0.2) 1.8  (0.1)
Visit 2 - Week 6 2.1  (0.2) 1.8  (0.1)
Visit 3 - Week 12 2.1  (0.2) 1.8  (0.2)
5.Secondary Outcome
Title Glycemic Control
Hide Description measuring HbA1c levels
Time Frame Baseline, 6 and 12 weeks post saxagliptin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Saxagliptin
Hide Arm/Group Description:
Placebo: 1 tablet daily for 12 weeks
Saxagliptin: 5 mg tablet once daily for 12 weeks
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: % of Glycosylated Hemoglobin
Visit 1 - Baseline 6.6  (0.1) 7.0  (0.2)
Visit 2 - Week 6 6.6  (0.1) 6.8  (0.2)
Visit 3 - Week 12 6.5  (0.1) 6.7  (0.2)
6.Secondary Outcome
Title Adiposity
Hide Description measured using a Tanita Body Composition Fat Analyzer scale, measured as percentage body fat
Time Frame Baseline, 6 and 12 weeks post saxagliptin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Saxagliptin
Hide Arm/Group Description:
Placebo: 1 tablet daily for 12 weeks
Saxagliptin: 5 mg tablet once daily for 12 weeks
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: % of Body fat
Visit 1 - Baseline 34  (2) 37  (2)
Visit 2 - Week 6 34  (2) 36.5  (2)
Visit 3 - Week 12 35  (2) 36  (2)
7.Secondary Outcome
Title Arterial Stiffness
Hide Description Arterial stiffness assessed using Vascular Flow and wave measurement equipment, SphygmoCor CP system from ATCOR. Reported as Augmentation Index adjusted for a heart rate of 75. Augmentation index (AIx) is a measure of systemic arterial stiffness derived from the ascending aortic pressure waveform. Lower the value, better correlated outcome as positive augmentation represents stiffer artery.
Time Frame Baseline, 6 and 12 weeks post saxagliptin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Saxagliptin
Hide Arm/Group Description:
Placebo: 1 tablet daily for 12 weeks
Saxagliptin: 5 mg tablet once daily for 12 weeks
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: Augmentation Index
Visit 1: Baseline 18.4  (2.4) 24.1  (2.1)
Visit 2: Week 6 26  (3.9) 22.5  (2.0)
Visit 3: Week 12 23.3  (2.3) 23.1  (2.1)
Time Frame 20 weeks
Adverse Event Reporting Description from the day ICF was signed till 1 month after V3.
 
Arm/Group Title Placebo Saxagliptin
Hide Arm/Group Description Placebo: 1 tablet daily for 12 weeks Saxagliptin 5mg once daily for 12 weeks
All-Cause Mortality
Placebo Saxagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Saxagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   1/21 (4.76%)   1/21 (4.76%) 
Cardiac disorders     
Hypertensive Urgency   1/21 (4.76%)  0/21 (0.00%) 
Chest Pain   0/21 (0.00%)  1/21 (4.76%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Saxagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Limitations of our study may include the relatively short duration of 12 week Saxagliptin therapy, which may have been inadequate to see significant changes in certain clinical and cellular parameters.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Saby Sen
Organization: The George Washington University
Phone: 202-994-8560
EMail: ssen1@gwu.edu
Responsible Party: Sabyasachi Sen, George Washington University
ClinicalTrials.gov Identifier: NCT02024477     History of Changes
Other Study ID Numbers: CV181-305
First Submitted: December 13, 2013
First Posted: December 31, 2013
Results First Submitted: August 14, 2018
Results First Posted: January 29, 2019
Last Update Posted: February 15, 2019