Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell

Seoul National University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Dapagliflozin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02420392

H1407-176-598

Details and patient eligibility

About

To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta cell.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Type 2 diabetes for dapagliflozin arm
• Normal glucose tolerance (fasting plasma glucose <100 mgd/l, HbA1c <6.0%) for normal glucose tolerance arm
• Age 18 to 75 years
• BMI <35 kg/m2
• For type 2 diabetes patients, at least 3 months of treatment period and HbA1c 7.5 to 11.0% and treatment with lifestyle modification and/or metformin or sulfonylurea

Exclusion criteria

• Who is allergic to dapagliflozin
• Type 1 diabetes
• Patients with history of diabetic ketoacidosis
• Reduced renal function (eGFR <60ml/min/1.73m2)
• Taking loop diuretics or dehydrated patient
• History of hypotension when taking hypertensive medication
• Diagnosed with heart failure
• Diagnosed with cerebral infarction
• Taking insulin, DPP-4 inhibitor, GLP-1 analogue, pioglitazone, alpha-glucosidase inhibitor
• Above upper limit of normal hematocrit range (male 39-52%, female 36-48%)
• Pregnant or breastfeeding women
• History of recurrent genitourinary infection
• AST/ALT more than two fold increased above normal upper limit
• Hemolytic disorder

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Dapagliflozin treatment

Experimental group

Description:

Test incretin sensitivity after dapagliflozin treatment in type 2 diabetes patients

Treatment:

Drug: Dapagliflozin

Normal glucose tolerance

No Intervention group

Description:

Test incretin sensitivity in subjects with normal glucose tolerance