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The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Group 1
Group 2
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Insulin

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged ≥ 19 years
  • Treated for T2D for at least 6 months
  • Uncontrolled T2D
  • Use of SMPG
  • HbA1c > 7% and ≤ 10% in patients with a basal insulin (Gla-100, Gla-300, neutral protamine Hagedorn (NPH), and detemir) or HbA1c > 7% and ≤ 11% in insulin naive patients
  • Signed informed consent

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Pregnancy or lactation
  • Night-shift worker
  • Unwilling to inject insulin or perform SMPG
  • Treated with insulin other than basal insulin within the previous 3 months
  • Not on stable dose of basal insulin (±20%) in the last 3 months
  • Initiation or change in dose of oral anti-hyperglycemic agents in the last 3 months
  • History of alcohol or drug abuse
  • Active cancer or other significant comorbidities which the investigator would make the patients unsuitable for participating in the study
  • Any clinically significant laboratory finding which the which the investigator would make the patients unsuitable for participating in the study
  • Known drug allergy to insulin
  • Not signed informed consent
  • Incompletion of the study
  • Participating in another clinical trial

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

In group 1, the dose of Gla-300 will be titrated by the patients by 1 unit per day until achieving a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (INSIGHT algorithm). Titration algorithms: Patients will be instructed to daily adjust their dose of Gla-300 based on fasting SMPG values. Fasting SMPG will be measured daily by the patient before breakfast and any intake of antihyperglycemic agents. Fasting SMPG in the range of ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose > 4.4 and ≤ 5.6 mmol/L, no change < 4.4 mmol/L, reduce 1 unit of Gla-300 dose

In group 2, the dose of Gla-300 will be titrated by the patients based on the SMPG values of the last 3 days at least weekly, but no more often than every 3 days to achieve a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (EDITION algorithm). Fasting SMPG (median of the last 3 days including current day) in the range of ≥ 7.8 mmol/L, increase 6 units of Gla-300 dose > 5.6 and < 7.8 mmol/L, increase 3 units of Gla-300 dose > 4.4 and ≤ 5.6 mmol/L, no change ≥ 3.3 and < 4.4 mmol/L, reduce 3 units of Gla-300 dose < 3.3 mmol/L or occurrence of ≥ 2 symptomatic or 1 severe hypoglycemic episode in the preceding week, reduce 3 units of Gla-300 dose or at the discretion of the investigator

Outcomes

Primary Outcome Measures

Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks

Secondary Outcome Measures

Changes in HbA1c (%)
Fasting plasma glucose (mmol/L)
Fasting SMPG (mmol/L)
7-point SMPG (mmol/L)
Proportion of patients at HbA1c ≤ 7%
Change in insulin dose (IU)
Change in body weight (kilogram)
Hypoglycemia (number of patients)
Adverse events
Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs)
Health care professionals' satisfaction to the insulin titration methods (evaluated by prespecirfied questionnaire: health care provider treatment satisfaction questionnaire)

Full Information

First Posted
December 18, 2017
Last Updated
October 21, 2020
Sponsor
Seoul National University Hospital
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03406663
Brief Title
The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300
Official Title
A Korean, Single-center, Open-label, Randomized Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
July 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to demonstrate efficacy and safety of self-titration algorithm with Gla-300 using the INSIGHT algorithm (once daily by 1 unit) and the EDITION algorithm (once weekly by 3 units) in Korean patients with T2D.
Detailed Description
The primary objective of this study is to obtain efficacy and safety descriptive data on two different titration algorithms: the INSIGHT titration algorithm (self-titration of 1 unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL (GLA-300) when given as basal insulin in uncontrolled T2DM patients on basal insulin with or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients. In a Korean, single-center, type 2 diabetes patients with basal insulin therapy will be enrolled. They will be randomly assigned to either titration algorithm for GLA-300. After 12 weeks, the glycemic control, patients' satisfaction to the titration methods and healthcare providers' satisfaction to titration methods will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
In group 1, the dose of Gla-300 will be titrated by the patients by 1 unit per day until achieving a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (INSIGHT algorithm). Titration algorithms: Patients will be instructed to daily adjust their dose of Gla-300 based on fasting SMPG values. Fasting SMPG will be measured daily by the patient before breakfast and any intake of antihyperglycemic agents. Fasting SMPG in the range of ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose > 4.4 and ≤ 5.6 mmol/L, no change < 4.4 mmol/L, reduce 1 unit of Gla-300 dose
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
In group 2, the dose of Gla-300 will be titrated by the patients based on the SMPG values of the last 3 days at least weekly, but no more often than every 3 days to achieve a fasting SMPG in the target range of 4.4 to 5.6 mmol/L (EDITION algorithm). Fasting SMPG (median of the last 3 days including current day) in the range of ≥ 7.8 mmol/L, increase 6 units of Gla-300 dose > 5.6 and < 7.8 mmol/L, increase 3 units of Gla-300 dose > 4.4 and ≤ 5.6 mmol/L, no change ≥ 3.3 and < 4.4 mmol/L, reduce 3 units of Gla-300 dose < 3.3 mmol/L or occurrence of ≥ 2 symptomatic or 1 severe hypoglycemic episode in the preceding week, reduce 3 units of Gla-300 dose or at the discretion of the investigator
Intervention Type
Behavioral
Intervention Name(s)
Group 1
Other Intervention Name(s)
INSIGHT algorithm
Intervention Description
Patients will be instructed to daily adjust their dose of Gla-300 based on fasting SMPG values. Fasting SMPG will be measured daily by the patient before breakfast and any intake of antihyperglycemic agents. Fasting SMPG in the range of ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose, > 4.4 and ≤ 5.6 mmol/L, no change, < 4.4 mmol/L, reduce 1 unit of Gla-300 dose
Intervention Type
Behavioral
Intervention Name(s)
Group 2
Other Intervention Name(s)
EDITION algorithm
Intervention Description
Fasting SMPG (median of the last 3 days including current day) in the range of 7.8 mmol/L, increase 6 units of Gla-300 dose, > 5.6 and < 7.8 mmol/L, increase 3 units of Gla-300 dose, > 4.4 and ≤ 5.6 mmol/L, no change, 3.3 and < 4.4 mmol/L, reduce 3 units of Gla-300 dose, < 3.3 mmol/L or occurrence of ≥ 2 symptomatic or 1 severe hypoglycemic episode in the preceding week, reduce 3 units of Gla-300 dose or at the discretion of the investigator
Primary Outcome Measure Information:
Title
Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Changes in HbA1c (%)
Time Frame
up to 12 weeks
Title
Fasting plasma glucose (mmol/L)
Time Frame
up to 12 weeks
Title
Fasting SMPG (mmol/L)
Time Frame
up to 12 weeks
Title
7-point SMPG (mmol/L)
Time Frame
up to 12 weeks
Title
Proportion of patients at HbA1c ≤ 7%
Time Frame
up to 12 weeks
Title
Change in insulin dose (IU)
Time Frame
up to 12 weeks
Title
Change in body weight (kilogram)
Time Frame
up to 12 weeks
Title
Hypoglycemia (number of patients)
Time Frame
up to 12 weeks
Title
Adverse events
Time Frame
up to 12 weeks
Title
Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs)
Time Frame
up to 12 weeks
Title
Health care professionals' satisfaction to the insulin titration methods (evaluated by prespecirfied questionnaire: health care provider treatment satisfaction questionnaire)
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥ 19 years Treated for T2D for at least 6 months Uncontrolled T2D Use of SMPG HbA1c > 7% and ≤ 10% in patients with a basal insulin (Gla-100, Gla-300, neutral protamine Hagedorn (NPH), and detemir) or HbA1c > 7% and ≤ 11% in insulin naive patients Signed informed consent Exclusion Criteria: Type 1 diabetes mellitus Pregnancy or lactation Night-shift worker Unwilling to inject insulin or perform SMPG Treated with insulin other than basal insulin within the previous 3 months Not on stable dose of basal insulin (±20%) in the last 3 months Initiation or change in dose of oral anti-hyperglycemic agents in the last 3 months History of alcohol or drug abuse Active cancer or other significant comorbidities which the investigator would make the patients unsuitable for participating in the study Any clinically significant laboratory finding which the which the investigator would make the patients unsuitable for participating in the study Known drug allergy to insulin Not signed informed consent Incompletion of the study Participating in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Min Cho, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34130445
Citation
Bae JH, Ahn CH, Yang YS, Moon SJ, Kwak SH, Jung HS, Park KS, Cho YM. Efficacy and Safety of Self-Titration Algorithms of Insulin Glargine 300 units/mL in Individuals with Uncontrolled Type 2 Diabetes Mellitus (The Korean TITRATION Study): A Randomized Controlled Trial. Diabetes Metab J. 2022 Jan;46(1):71-80. doi: 10.4093/dmj.2020.0274. Epub 2021 Jun 16.
Results Reference
derived

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The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300

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