The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 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 |
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
Other Names:
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| Active Comparator: Group 2 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 |
Behavioral: 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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks [up to 12 weeks]
Secondary Outcome Measures
- 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]
- Change in insulin dose (IU) [up to 12 weeks]
- Change in body weight (kilogram) [up to 12 weeks]
- Hypoglycemia (number of patients) [up to 12 weeks]
- Adverse events [up to 12 weeks]
- Patient satisfaction to the insulin titration method (evaluated by prespecified questionnaire: DTSQs) [up to 12 weeks]
- Health care professionals' satisfaction to the insulin titration methods (evaluated by prespecirfied questionnaire: health care provider treatment satisfaction questionnaire) [up to 12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged ≥ 19 years
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Treated for T2D for at least 6 months
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Uncontrolled T2D
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Use of SMPG
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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
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Signed informed consent
Exclusion Criteria:
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Type 1 diabetes mellitus
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Pregnancy or lactation
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Night-shift worker
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Unwilling to inject insulin or perform SMPG
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Treated with insulin other than basal insulin within the previous 3 months
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Not on stable dose of basal insulin (±20%) in the last 3 months
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Initiation or change in dose of oral anti-hyperglycemic agents in the last 3 months
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History of alcohol or drug abuse
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Active cancer or other significant comorbidities which the investigator would make the patients unsuitable for participating in the study
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Any clinically significant laboratory finding which the which the investigator would make the patients unsuitable for participating in the study
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Known drug allergy to insulin
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Not signed informed consent
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Incompletion of the study
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Participating in another clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 |
Sponsors and Collaborators
- Seoul National University Hospital
- Sanofi
Investigators
- Principal Investigator: Young Min Cho, MD, PhD, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-1708-078-878