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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dapagliflozin treatment

Test incretin sensitivity after dapagliflozin treatment in type 2 diabetes patients

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

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

Normal glucose tolerance

Test incretin sensitivity in subjects with normal glucose tolerance

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dapagliflozin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes