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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Obesity; Type 2 Diabetes

Treatments: Drug: Saxagliptin (Bristol-Myers Squibb Company)

Study type: Interventional

Funder types: Other

Identifiers

NCT02583438

Saxa015

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Lifestyle intervention

Experimental group

Treatment:

Drug: Saxagliptin (Bristol-Myers Squibb Company)