Type 2 Diabetes Mellitus
Conditions
Keywords
Insulin
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.
Interventions
BEHAVIORALGroup 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
BEHAVIORALGroup 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
Sponsors
Sanofi
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving fasting SMPG ≤ 5.6 mmol/L without hypoglycemia at 12 weeks | up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Changes in HbA1c (%) | 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 |
| Change in body weight (kilogram) | up to 12 weeks |
Countries
South Korea
Outcome results
None listed