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

NCT03406663 | Completed

• 1 other identifier: H-1708-078-878
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Insulin

Outcome Measures

Primary Outcomes (1)

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

  up to 12 weeks

Secondary Outcomes (11)

• Changes in HbA1c (%)

  up to 12 weeks

• Fasting plasma glucose (mmol/L)

  up to 12 weeks

• Fasting SMPG (mmol/L)

  up to 12 weeks

• 7-point SMPG (mmol/L)

  up to 12 weeks

• Proportion of patients at HbA1c ≤ 7%

  up to 12 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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 1. ≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose 2. \> 4.4 and ≤ 5.6 mmol/L, no change 3. \< 4.4 mmol/L, reduce 1 unit of Gla-300 dose

Behavioral: Group 1

Group 2

ACTIVE COMPARATOR

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 1. ≥ 7.8 mmol/L, increase 6 units of Gla-300 dose 2. \> 5.6 and \< 7.8 mmol/L, increase 3 units of Gla-300 dose 3. \> 4.4 and ≤ 5.6 mmol/L, no change 4. ≥ 3.3 and \< 4.4 mmol/L, reduce 3 units of Gla-300 dose 5. \< 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

Behavioral: Group 2

Interventions

Group 1 BEHAVIORAL

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

Also known as: INSIGHT algorithm

Group 1

Group 2 BEHAVIORAL

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

Also known as: EDITION algorithm

Group 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Sanofi: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34130445 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Young Min Cho, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 23, 2018
• Study Start: October 1, 2017
• Primary Completion: January 17, 2020
• Study Completion: July 14, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

KR (1)