Overview

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

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
All
Summary
To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta cell.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Seoul National University Hospital
Collaborator:
AstraZeneca
Treatments:
Dapagliflozin
Incretins
Criteria
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