Effects of SGLT2 Inhibitors on Islet Cell Function and Insulin Sensitivity in Patients of Type 2 Diabetes Mellitus

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04014192
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
    Treated with dapagliflozin 10mg/d for one week.
  • Empagliflozin — DRUG
    Treated with empagliflozin 10mg/d for one week.
  • Canagliflozin — DRUG
    Treated with canagliflozin 100mg/d for one week.

Study Details

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 kind of newly developed hypoglycemic medicine, which increases urinary glucose excretion and lowers blood glucose in an insulin-independent manner. The mechanisms of its effects on insulin resistance, insulin secretion by pancreatic beta cells and glucagon secretion by pancreatic alpha cells, are not well studied in domestic and foreign, and there is no unified conclusion. A few studies concerning SGLT2 inhibitors have observed that insulin resistance and islet beta cell secretion function can be improved by the improvement of glucotoxicity and lipotoxicity, but its effect on pancreatic alpha cell function to increase glucagon level, thereby increasing liver glucose output, may be one of the mechanisms of its side effects. In this study, patients with type 2 diabetes mellitus were treated with three domestic listed SGLT2 inhibitors (dapagliflozin, empagliflozin and canagliflozin) for one week, which were expected to improve the glucotoxicity, but excluding the effects on lipotoxicity and body weight, to observe the changes of islet beta cell and alpha cell function and insulin sensitivity. Three different SGLT2 inhibitors were used in order to make clear whether this effect is the unique effect of different structure of drugs or the similar effect of this kind of drugs.

Key Dates

Start date
Sep 1, 2019
Status verified
Aug 2019
Primary completion
Jul 31, 2020
Completion
Jul 31, 2020

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin Group
    10mg/d for one week
  • Experimental: Empagliflozin Group
    10mg/d for one week
  • Experimental: Canagliflozin Group
    100mg/d for one week
  • No Intervention: Normal Glucose Tolerance Group

Primary Outcome Measure

Change from baseline to post-treatment in insulin sensitivity. [ Time Frame: Baseline, Week 1(extended to Week 2 if without significantly decrease in blood glucose) ]

Central Contacts

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