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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Dapagliflozin

• Registration Number: NCT02420392
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-11
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-17
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dapagliflozin treatment	Dapagliflozin	Test incretin sensitivity after dapagliflozin treatment in type 2 diabetes patients

Primary Outcome Measures

Name	Time	Method
Difference of incretin sensitivity of pancreatic beta cell measured by hyperglycemic clamp with GLP-1 and GIP infusion	From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp	Area under the curve of C-peptide level during GLP-1 infusion under hyperglycemic clamp

Secondary Outcome Measures

Name	Time	Method
First phase insulin/C-peptide response	From 0 to 10 minutes of hyperglycemic clamp
Second phase insulin/C-peptide response	From 10 to 60 minutes of hyperglycemic clamp
Area under the curve of insulin level during GLP-1 infusion under hyperglycemic clamp	From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp
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	From 120 minutes to 180 minutes during GIP infusion under hyperglycemic clamp
Area under the curve of insulin/C-peptide level during GIP infusion under hyperglycemic clamp	From 120 minutes to 180 minutes during GIP infusion under hyperglycemic clamp
Difference of incretin sensitivity between diabetes patients and normal glucose tolerance subjects	From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp	Area under the curve of C-peptide level during GLP-1 infusion under hyperglycemic clamp
Difference of first phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects	From 0 to 10 minutes of hyperglycemic clamp
Difference of second phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects	From 10 to 60 minutes of hyperglycemic clamp
Difference of area under the curve of insulin level during GLP-1 infusion under hyperglycemic clamp between diabetes patients and normal glucose tolerance subjects	From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of