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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406663
• Other study ID #: H-1708-078-878
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: July 14, 2020

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 14, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Group 1
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
• Group 2
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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving fasting SMPG = 5.6 mmol/L without hypoglycemia at 12 weeks		up to 12 weeks
Secondary	Changes in HbA1c (%)		up to 12 weeks
Secondary	Fasting plasma glucose (mmol/L)		up to 12 weeks
Secondary	Fasting SMPG (mmol/L)		up to 12 weeks
Secondary	7-point SMPG (mmol/L)		up to 12 weeks
Secondary	Proportion of patients at HbA1c = 7%		up to 12 weeks
Secondary	Change in insulin dose (IU)		up to 12 weeks
Secondary	Change in body weight (kilogram)		up to 12 weeks
Secondary	Hypoglycemia (number of patients)		up to 12 weeks
Secondary	Adverse events		up to 12 weeks
Secondary	Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs)		up to 12 weeks
Secondary	Health care professionals' satisfaction to the insulin titration methods (evaluated by prespecirfied questionnaire: health care provider treatment satisfaction questionnaire)		up to 12 weeks