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Genetic Variants Replication Study Associated With Dependence on Sulfonylurea in Participants With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04123587
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Information provided by (Responsible Party):
Hye Seung Jung, Seoul National University Hospital

Brief Summary:
This study was designed to reproduce candidate single nucleotide variants found by whole exome sequencing in some type 2 diabetic patients dependent on sulfonylurea in a separate patient group. The validation of the dependence-related variations performed in this study is expected to help decision-making in the clinical use of sulfonylurea in the future.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: discontinuation of Sulfonylureas Phase 4

Detailed Description:

Sulfonylurea, one of the oral hypoglycemic agents, is the oldest and most widely used drug. The use of sulfonylurea was overwhelming compared to metformin especially in East Asia, where insulin secretion was notable during the pathophysiology of type 2 diabetes. However, sulfonylurea causes hypoglycemia and weight gain, increases cardiovascular disease and mortality compared to other oral preparations. With the recent development of other oral hypoglycemic agents for lowering blood glucose without the risk of hypoglycemia and with cardiovascular protection, sulfonylurea is in a decreasing state of use worldwide.

But some patients tend to be highly dependent on sulfonylurea for blood glucose control. It suggests that there will be a group of patients whose the action of sulfonylurea is strongly influenced by genetic factor, since insulin secretion of pancreatic beta cells is very hereditary, genetic variations that increase the risk of type 2 diabetes are found mainly in genes related to beta cell dysfunction rather than insulin resistance, and the more risk variants of type 2 diabetes, the less likely the effect of sulfonylurea is.

The investigators had performed whole exome sequencing in patients showing dependence on sulfonylurea and identified tens of candidate variants.

In this study, the investigators will select patients with dependence on sulfonylurea by prospective intervention (by discontinuing and resuming sulfonylurea) and perform genetic tests.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genetic Variants Replication Study Associated With Dependence on Sulfonylurea in Participants With Type 2 Diabetes
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sulfonylurea-dependent
Sulfonylurea is replaced by alternative oral hypoglycemic agent.
Drug: discontinuation of Sulfonylureas
  1. Discontinuation of sulfonylurea, alternative drug administration.
  2. If there is a significant increase in blood glucose, it is considered as a sulfonylurea-dependent patient. Discontinue the alternative drug and resume the sulfonylurea, and monitor for 12 weeks or until stabilization of blood glucose at short intervals.
  3. if blood glucose levels are within optimal range after replacement of sulfonylureas with other agents, the patient is regard as non-SU-dependent
Other Name: other oral anti-diabetics instead of sulfonylureas

Primary Outcome Measures :
  1. the list of previously found candidate variants which are observed in the slufonylurea-dependent patients but not in the non-dependent patients [ Time Frame: 20 weeks ]
    Dependency on sulfonylurea-dependency is determined according to changes in HbA1c by use of sulfonylurea. The 'previously found candidate variants' are the results from whole exome sequencing in patients showing dependence on sulfonylurea as a screening before.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Among patients with type 2 diabetes who visited Seoul National University Hospital endocrinology outpatient clinic, all of criteria (1)-(4) are satisfied

  1. Adults over 19 years
  2. More than 10 years of diabetes
  3. Low dose sulfonylurea use: Equivalent capacity 2 mg or less of glimepiride
  4. Less than 7.5% of glycated hemoglobin for more than 6 months
  5. estimated glomerular filtration rate > 50 mL/min/1.73㎡

Exclusion Criteria:

  • Type 1 diabetics
  • Insulin user
  • Patients diagnosed with cardiovascular disease, cancer, and other critical illness within 6 months before the study
  • Patients with severe hypertension
  • Patients with treatment or diseases that may have a significant effect on blood glucose levels, such as glucocorticoids and thyrotoxicosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04123587

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Contact: Han Na Jang, MD 82220722228

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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-144
Contact: Hye Seung Jung    +82-2-2072-0240   
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Hye Seung Jung, MD Seoul National University Hospital

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Responsible Party: Hye Seung Jung, Professor, Seoul National University Hospital Identifier: NCT04123587     History of Changes
Other Study ID Numbers: SU
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hye Seung Jung, Seoul National University Hospital:
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases