Diabetes Mellitus, Type 2NCT02420392

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

A study testing Dapagliflozin in people with Diabetes Mellitus, Type 2, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta cell. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Dapagliflozin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSouth Korea
Study dates: Feb 2015to Apr 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 110-744

Other trials in South Korea

About this study

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

Conditions: Diabetes Mellitus, Type 2
Being tested: Dapagliflozin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02420392
Study group	Role	What they receive
Dapagliflozin treatment	Experimental	Test incretin sensitivity after dapagliflozin treatment in type 2 diabetes patients Receives: Drug: Dapagliflozin
Normal glucose tolerance	No intervention	Test incretin sensitivity in subjects with normal glucose tolerance

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Apr 2016

First posted17 Apr 2015 (estimated)
Study startFeb 2015
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02420392
Sponsor's protocol ID: H1407-176-598
Status last verified: Apr 2016
First submitted: 11 Apr 2015
Last updated: 21 Apr 2016
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell
ClinicalTrials.gov ID: NCT02420392
Acronym / sponsor ID: H1407-176-598
Conditions: Diabetes Mellitus, Type 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Collaborators: AstraZeneca
Study start: Feb 2015
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 17 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dapagliflozin treatment	Experimental	Drug: DapagliflozinTest incretin sensitivity after dapagliflozin treatment in type 2 diabetes patients
Normal glucose tolerance	No intervention	–Test incretin sensitivity in subjects with normal glucose tolerance

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dapagliflozin8 weeks treatment of dapagliflozin added to the type 2 diabetes patients with unsufficiently controlled with metformin or sulfonylurea	Drug	Dapagliflozin treatment

Primary outcome

Difference of incretin sensitivity of pancreatic beta cell measured by hyperglycemic clamp with GLP-1 and GIP infusion
Time frame: 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

9 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.

Related trials for Diabetes Mellitus, Type 2

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Active, not recruiting
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Young Min Cho, M.D., Ph.D. principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dapagliflozin in people with Diabetes Mellitus, Type 2, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference of incretin sensitivity of pancreatic beta cell measured by hyperglycemic clamp with GLP-1 and GIP infusion (time frame: From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02420392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.