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CompletedNCT02920801Updated Oct 3, 2016

Study About Effect of Saxagliptin on Circulating Endothelial Progenitor Cells and Endothelial Function in Newly Diagnosed Type 2 Diabetic Patients

A Phase 4 interventional study of saxagliptin and Metformin in Type 2 Diabetes Mellitus, sponsored by Shanghai Zhongshan Hospital. Completed at 1 site in China. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-03.

Sponsored by Shanghai Zhongshan Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

In this study, the investigators aim to investigate whether saxagliptin modulate endothelial progenitor cells number and flow-mediated dilation in newly diagnosed, treatment-naive type 2 diabetic patients.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • saxagliptin
  • endothelial progenitor cell
  • flow-mediated dilation
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 31 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • newly diagnosed type 2 diabetics (diagnosis were made according to the American Diabetes Association Guideline [19] ), treatment naive, age 30-75, hemoglobin A1c (HbA1c) ≥6.5%, fasting c-peptide >1.0ng/L

Exclusion criteria

Exclusion Criteria:

  • pregnancy or lactation, smoker, acute disease or infection, chronic renal disease (estimated glomerular filtration rate \<60 mL/min/1.73m2), live enzymes 3 times above the normal range, positive islet autoantibody, fasting c-peptide \<1.0ng/L, severe hypertriglyceridemia (triglyceride >5.6mmol/L), cardiovascular events or surgery within 3 months, taking glucocorticoid, history of acute or chronic pancreatitis, pancreatic tumor, severe cardiac or pneumonic disease.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    saxagliptin group

    saxagliptin group consumed saxagliptin 5mg per day for 12 week

    Drug: saxagliptin

  • Active comparator
    metformin group

    metformin group consumed metformin 1500mg per day for 12 week

    Drug: Metformin

Interventions

  • Drugsaxagliptin

    5mg per day for 12 weeks

  • DrugMetformin

    1500mg per day for 12 weeks

06

What researchers measure

Primary outcomes

  1. endothelial progenitor cell

    Time frame: 12weeks

  2. flow-mediated dilation

    Time frame: 12weeks

Secondary outcomes

  1. HbA1c

    Time frame: 12weeks

  2. fasting blood glucose

    Time frame: 12weeks

  3. 2 hour postprandial blood glucose

    Time frame: 12weeks

  4. liver function test

    Time frame: 12weeks

  5. renal function test

    Time frame: 12weeks

07

Study locations

1 site
  • Fang Li
    Shanghai, Shanghai 200032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02920801
Lead sponsor
Shanghai Zhongshan Hospital
Collaborators
Chinese Medical Association
Responsible party
Yan Ling (associate professor, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Sep 30, 2016
Start date
Dec 2014
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Oct 3, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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