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

NCT03660683 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 180295
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Keywords

saxagliptin dapagliflozin diabetes cardiovascular diseases EPC

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (8)

• CD 34+ Cell Gene Expression

  16 weeks from visit 1

• CD 34+ Cell Fraction

  16 weeks

• Arterial Stiffness - Augmentation Index

  16 Weeks

• Blood Biochemistries

  16 Weeks

• Renal Function

  16 Weeks

Other Outcomes (5)

• Fasting Lipid Profile

  16 Weeks

• Serum Insulin Level

  16 Weeks

• Serum Glucose

  16 Weeks

Study Arms (3)

Group A Dapa

EXPERIMENTAL

Dapagliflozin 10 mg + Saxagliptin Placebo

Drug: Dapagliflozin 10mg

Group B DapaSaxa

ACTIVE COMPARATOR

Dapagliflozin 10mg + Saxagliptin 5mg

Drug: Dapagliflozin 10mg; Drug: Saxagliptin 5mg

Placebo

PLACEBO COMPARATOR

Placebo Oral Tablet

Drug: Placebo Oral Tablet

Interventions

Dapagliflozin 10mg DRUG

Dapagliflozin 10mg PO QD

Also known as: Farxiga

Group A Dapa; Group B DapaSaxa

Saxagliptin 5mg DRUG

Saxagliptin 5 mg PO QD

Also known as: Onglyza

Group B DapaSaxa

Placebo Oral Tablet DRUG

Matching Placebo Tablets

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Sabyasachi Sen: lead

Study Sites (1)

The GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

• 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.

  PMID: 39865301 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

dapagliflozin; saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Study is limited by the small cohort used in each group. Many visit 2 data points missing, reported analysis only performed with visit 1 and 3 data.

Results Point of Contact

• Title: Dr. Sabyasachi Sen
• Organization: George Washington University Medical Faculty Associates

ssen1@email.gwu.edu

301-461-6676

Study Officials

• Sabyasachi Sen, MD, PhD

  GWU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Dept. of Medicine (Division of Endocrinology)

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 6, 2018
• Study Start: October 22, 2018
• Primary Completion: March 11, 2021
• Study Completion: December 10, 2021
• Last Updated: June 5, 2023
• Results First Posted: June 5, 2023

Record last verified: 2023-06

Locations

US (1)