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

NCT04123587 | Completed Phase 4 DMC

• 1 other identifier: SU
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Sulfonylurea

Outcome Measures

Primary Outcomes (1)

• the list of previously found candidate variants which are observed in the slufonylurea-dependent patients but not in the non-dependent patients

  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.

  20 weeks

Study Arms (1)

Sulfonylurea-dependent

EXPERIMENTAL

Sulfonylurea is replaced by alternative oral hypoglycemic agent.

Drug: discontinuation of Sulfonylureas

Interventions

discontinuation of Sulfonylureas DRUG

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

Also known as: other oral anti-diabetics instead of sulfonylureas

Sulfonylurea-dependent

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Among patients with type 2 diabetes who visited Seoul National University Hospital endocrinology outpatient clinic, all of criteria (1)-(4) are satisfied
• Adults over 19 years
• More than 10 years of diabetes
• Low dose sulfonylurea use: Equivalent capacity 2 mg or less of glimepiride
• Less than 7.5% of glycated hemoglobin for more than 6 months
• estimated glomerular filtration rate \> 50 mL/min/1.73㎡

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-144, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Hye Seung Jung, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: October 11, 2019
• Study Start: September 10, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

KR (1)