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

NCT ID: NCT02583438

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-01-31

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.

Conditions

Type 2 Diabetes; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle intervention

Group Type: EXPERIMENTAL

Saxagliptin (Bristol-Myers Squibb Company)

Intervention Type: DRUG

6-month treatment of Saxagliptin 5mg Qd

Interventions

Saxagliptin (Bristol-Myers Squibb Company)

6-month treatment of Saxagliptin 5mg Qd

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guang Wang

Department of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Saxa015

Identifier Type: -

Identifier Source: org_study_id