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

NCT02420392 | Completed DMC

• 1 other identifier: H1407-176-598
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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

• 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

Study Arms (2)

Dapagliflozin treatment

EXPERIMENTAL

Test incretin sensitivity after dapagliflozin treatment in type 2 diabetes patients

Drug: Dapagliflozin

Normal glucose tolerance

NO INTERVENTION

Test incretin sensitivity in subjects with normal glucose tolerance

Interventions

Dapagliflozin DRUG

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

Dapagliflozin treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Young Min Cho, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 11, 2015
• First Posted: April 17, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

KR (1)