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Evaluate the Effect of Saxagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02583438
Recruitment Status : Unknown
Verified October 2015 by Guang Wang, Beijing Chao Yang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2015
Last Update Posted : October 22, 2015
Information provided by (Responsible Party):
Guang Wang, Beijing Chao Yang Hospital

Brief Summary:
The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Drug: Saxagliptin (Bristol-Myers Squibb Company) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beijing Chao-yang Hospital, Capital Medical University
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin

Arm Intervention/treatment
Experimental: Lifestyle intervention Drug: Saxagliptin (Bristol-Myers Squibb Company)
6-month treatment of Saxagliptin 5mg Qd

Primary Outcome Measures :
  1. gut microbiota [ Time Frame: Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months ]

Secondary Outcome Measures :
  1. The improvement of intestinal microflora imbalance [ Time Frame: Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks) ]
  2. The change of inflammatory markers [ Time Frame: The change of inflammatory markers (baseline, 12 weeks) ]
    The effect on plasma levels of inflammatory markers, such as IL-1B, IL-6 and TNF-α(baseline, 12 weeks)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Females or males, and aged 20 to 65 years.
  • Newly diagnosed type 2 diabetes
  • HbA1C ≥7% and HbA1C <9%

Exclusion Criteria:

  • Hepatic insufficiency (ALT or AST> 1.5*ULN)
  • Renal insufficiency [Creatinine clearance rate (Ccr)]<60ml/min estimated from MDRD equation)
  • Coronary artery disease
  • Thyroid disease
  • Infectious disease
  • Systemic inflammatory disease
  • Cancer
  • Subjects who were taking agents known to influence gut microbiota
  • Pregnant or lactating woman
  • Other conditions at investigator's discretion

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Responsible Party: Guang Wang, Department of Endocrinology, Beijing Chao Yang Hospital Identifier: NCT02583438    
Other Study ID Numbers: Saxa015
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015
Keywords provided by Guang Wang, Beijing Chao Yang Hospital:
Gut Microbiota
inflammatory marker
Glucose and lipid metabolism
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents