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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 response

Second 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

Page last updated: August 23, 2015

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