Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s): Young Min Cho, M.D., Ph.D., Principal Investigator, Affiliation: Seoul National University Hospital
Overall contact: Young Min Cho, M.D., Ph.D., Email: ymchomd@snu.ac.kr
Summary
To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic
beta cell.
Clinical Details
Official title: Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Difference of incretin sensitivity of pancreatic beta cell measured by hyperglycemic clamp with GLP-1 and GIP infusion
Secondary outcome: First phase insulin/C-peptide responseSecond phase insulin/C-peptide response Area under the curve of insulin level during GLP-1 infusion under hyperglycemic clamp Area under the curve of insulin/C-peptide level during GIP infusion under hyperglycemic clamp Difference of incretin sensitivity between diabetes patients and normal glucose tolerance subjects Difference of first phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects Difference of second phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects Difference of area under the curve of insulin level during GLP-1 infusion under hyperglycemic clamp between diabetes patients and normal glucose tolerance subjects Difference of Area under the curve of insulin/C-peptide level during GIP infusion under hyperglycemic clamp between diabetes patients and normal glucose tolerance subjects
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Young Min Cho, M.D., Ph.D., Email: ymchomd@snu.ac.kr
Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting Young Min Cho, MD, PHD, Phone: 82-2-2072-1965, Email: ymchomd@snu.ac.kr
Additional Information
Starting date: August 2014
Last updated: April 14, 2015
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