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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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ClinicalTrials.gov Identifier: NCT02920801
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : October 3, 2016
Sponsor:
Collaborator:
Chinese Medical Association
Information provided by (Responsible Party):
Yan Ling, Shanghai Zhongshan Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: saxagliptin Drug: Metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: saxagliptin group
saxagliptin group consumed saxagliptin 5mg per day for 12 week
Drug: saxagliptin
5mg per day for 12 weeks

Active Comparator: metformin group
metformin group consumed metformin 1500mg per day for 12 week
Drug: Metformin
1500mg per day for 12 weeks




Primary Outcome Measures :
  1. endothelial progenitor cell [ Time Frame: 12weeks ]
  2. flow-mediated dilation [ Time Frame: 12weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920801


Locations
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China, Shanghai
Fang Li
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Chinese Medical Association

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Responsible Party: Yan Ling, associate professor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02920801     History of Changes
Other Study ID Numbers: 13040490434
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016

Keywords provided by Yan Ling, Shanghai Zhongshan Hospital:
saxagliptin
endothelial progenitor cell
flow-mediated dilation

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Saxagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action