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

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Fudan University

Status and phase

Completed
Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Metformin
Drug: saxagliptin

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT02920801
13040490434

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

31 participants in 2 patient groups

saxagliptin group
Experimental group
Description:
saxagliptin group consumed saxagliptin 5mg per day for 12 week
Treatment:
Drug: saxagliptin
metformin group
Active Comparator group
Description:
metformin group consumed metformin 1500mg per day for 12 week
Treatment:
Drug: Metformin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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