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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02024477
• Date of registration: 13/12/2013
• Prospective Registration: No
• Primary sponsor: George Washington University
• Public title: Effect of Saxagliptin on EPCs as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early T2DM Patients
• Scientific title: Effect of Saxagliptin (DPP-4 Inhibitor) on Endothelial Progenitor Cells (EPCs) as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early Type 2 Diabetes Patients
• Date of first enrolment: November 2013
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02024477
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Sabyaschi Sen, PhD, MD
• Affiliation: George Washington University

Key inclusion & exclusion criteria

Inclusion Criteria

1. Adults aged 40-70 years.

2. Diagnosis of type 2 diabetes within the previous 8 years using criteria of the
American Diabetes Association

3. Currently treated with no hypoglycemic agents other than a stable dose (>3 months) of
metformin (=1.0 to =2 grams daily).

4. HbA1C between 6 to 9% (both inclusive)

5. BMI 25 to 39.9 kg/m2 (both inclusive)

Exclusion Criteria:

1. Contraindications for moderate exercise

2. Implanted devices (e.g., pacemakers) that may interact with Tanita scale

3. Previous coronary or cerebrovascular event within 6 months of screening or active or
clinically significant coronary and/or peripheral vascular disease.

4. Low hematocrit <28 Units

5. Pre-existing liver disease and/or ALT and AST >2.5X's UNL

6. Kidney disease (serum creatinine levels =1.5 mg/dL for men, =1.4 mg/dL for
women,Creatinine Clearance =50 mL/min)

7. History of pancreatitis, or cancer (except basal cell carcinoma)

8. Statin use started (or dose change) in the last 3 months.

9. Use of oral or injectable anti-diabetic medication other than Metformin

10. Use of any form of consistent-long term steroid medication (oral, inhaled injected or
nasal) within the last 3 months

11. Systolic BP> 140 mmHg and diastolic BP> 90 mmHg

12. Active wounds or recent surgery within 3 months.

13. Inflammatory disease, or current use of anti-inflammatory drugs

14. triglycerides >400 mg/dL

15. untreated hyper/hypothyroidism 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.

Patients on low dose oral contraceptives will be allowed to participate as these
formulations contain lesser amount of estrogens.



Age minimum: 40 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: Placebo

Drug: Saxagliptin

Primary Outcome(s)

CD34+ Endothelial Progenitor Cells Number [Time Frame: Up to 12 weeks post saxagliptin]

CD 34+ Cell Function [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]

Secondary Outcome(s)

Glycemic Control [Time Frame: Baseline, 6 and 12 weeks post saxagliptin]

Serum Endothelial Inflammatory Marker hsCRP [Time Frame: Baseline 6 and 12 weeks post saxagliptin]

Arterial Stiffness [Time Frame: Baseline, 6 and 12 weeks post saxagliptin]

Adiposity [Time Frame: Baseline, 6 and 12 weeks post saxagliptin]

Fasting Lipid Profile LDL/HDL [Time Frame: Baseline, 6 and 12 weeks post saxagliptin]

Secondary ID(s)

CV181-305

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca

Results

• Results available: Yes
• Date Posted: 29/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02024477