Skip to main content
OpenTrials
Completed

NCT Number: NCT03406663

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: INSIGHT algorithm

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

Other names: EDITION algorithm

Primary outcomes

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

    Time frame: up to 12 weeks

Secondary outcomes

  1. Changes in HbA1c (%)

    Time frame: up to 12 weeks

  2. Fasting plasma glucose (mmol/L)

    Time frame: up to 12 weeks

  3. Fasting SMPG (mmol/L)

    Time frame: up to 12 weeks

  4. 7-point SMPG (mmol/L)

    Time frame: up to 12 weeks

  5. Proportion of patients at HbA1c ≤ 7%

    Time frame: up to 12 weeks

  6. Change in insulin dose (IU)

    Time frame: up to 12 weeks

  7. Change in body weight (kilogram)

    Time frame: up to 12 weeks

  8. Hypoglycemia (number of patients)

    Time frame: up to 12 weeks

  9. Adverse events

    Time frame: up to 12 weeks

  10. Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs)

    Time frame: up to 12 weeks

  11. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.