Status:
UNKNOWN
Effects of SGLT2 Inhibitors on Islet Cell Function and Insulin Sensitivity in Patients of Type 2 Diabetes Mellitus
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The main pathogenesis of type 2 diabetes mellitus is insulin resistance and insufficient secretion of insulin by pancreatic beta cells. SGLT2 (sodium-glucose synergistic transporter 2) inhibitor is a ...
Detailed Description
In this study, type 2 diabetes patients were treated with three kinds of SGLT2 inhibitors (dapagliflozin, empagliflozin and canagliflozin) for one week. With routine dose applied, (dapagliflozin 10mg/...
Eligibility Criteria
Inclusion
- (1)According to the diagnostic criteria of World Health Organization (WHO) in 1999, type 2 diabetes mellitus was diagnosed clinically. The age ranged from 18 to 70 years (including 18 and 70 years). There was no limit to the duration of diabetes mellitus and gender.
- (2)Basic antidiabetic therapy is not limited.
- (3)HbA1c ≥ 7%.
- (4)eGFR ≥60 ml/min；without contraindications to SGLT2 Inhibitors.
- (5)Sign written consent form voluntarily.
Exclusion
- (1)Other types of diabetes mellitus.
- (2)Unstable control of blood glucose(fasting blood glucose \> 11.1 mmol/L).
- (3)Acute complications of diabetes mellitus within 6 months.
- (4)History of myocardial infarction or stroke within 6 months, or existing severe cardiovascular disease and risk.
- (5)Abnormal liver function \[i.e. serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 1.5 times higher than the upper limit of normal value\].
- (6)Severe hypertension that defined as systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥90 mmHg with drug therapy, or hypotension (resting seat blood pressure \< 90/50 mmHg).
- (7)psychosis, alcohol dependence or history of drug abuse, lactation women, participation in other studies three months before the trial, allergic constitution or allergic to a variety of drug and those researchers think inappropriate to the research.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04014192
Start Date
September 1 2019
End Date
July 31 2020
Last Update
September 24 2019
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730