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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02420392
• Other study ID #: H1407-176-598
• Status: Completed
• Phase: N/A
• First received: April 11, 2015
• Last updated: April 20, 2016
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dapagliflozin
8 weeks treatment of dapagliflozin added to the type 2 diabetes patients with unsufficiently controlled with metformin or sulfonylurea

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of incretin sensitivity of pancreatic beta cell measured by hyperglycemic clamp with GLP-1 and GIP infusion	Area under the curve of C-peptide level during GLP-1 infusion under hyperglycemic clamp	From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp	No
Secondary	First phase insulin/C-peptide response		From 0 to 10 minutes of hyperglycemic clamp	No
Secondary	Second phase insulin/C-peptide response		From 10 to 60 minutes of hyperglycemic clamp	No
Secondary	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	No
Secondary	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	No
Secondary	Difference of incretin sensitivity between diabetes patients and normal glucose tolerance subjects	Area under the curve of C-peptide level during GLP-1 infusion under hyperglycemic clamp	From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp	No
Secondary	Difference of first phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects		From 0 to 10 minutes of hyperglycemic clamp	No
Secondary	Difference of second phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects		From 10 to 60 minutes of hyperglycemic clamp	No
Secondary	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	No
Secondary	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	No