The study aims to evaluate the efficacy and safety of IDegLira in type 2 diabetes who have failed premixed insulin therapy. The study plans to enroll 256 participants with inadequate glycemic control despite twice-daily subcutaneous injections of premixed insulin and metformin. Participants will be randomly assigned to either the premixed insulin dose optimization group (control group) or IDegLira once daily group, and the difference in change in glycated hemoglobin levels from baseline to 16 weeks of treatment will be assessed between the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
256
The participants in this group will be switched to IDegLira once daily injection therapy.
The participants in this group will be have optimized premixed insulin regimen.
Hemoglobin A1c (HbA1c)
The change in glycated hemoglobin levels from baseline at the end of the study
Time frame: From baseline to the end of the study (week 0-week 14 ± 7days).
Time in Range (TIR, 3.9-10.0 mmol/L) obtained from Continuous Glucose Monitoring (CGM)
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Time in Tight Range (TTIR, 3.9-7.8 mmol/L)
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Glucose Management Indicator (GMI)
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Prolonged Hypoglycemic Events (defined as glucose <3.9 mmol/L for ≥120 minutes, with event ending when glucose ≥3.9 mmol/L for ≥15 minutes)
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Prolonged Hyperglycemic Events (defined as glucose >13.9 mmol/L for ≥120 minutes, with event ending when glucose ≤10 mmol/L for ≥15 minutes)
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Percentage of patients with TIR (3.9-10 mmol/L) >70%
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Percentage of patients with ≥5% improvement in TIR (3.9-10 mmol/L) from baseline at study end.
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Percentage of patients with ≥10% improvement in TIR (3.9-10 mmol/L) from baseline at study end
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Percentage of patients with Time Below Range (TBR, <3.9 mmol/L) <4%
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Percentage of patients with Time Below Range (TBR, <3.0 mmol/L) <1%
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Percentage of patients with Time Above Range (TAR, >10.0 mmol/L) <25%
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
Percentage of patients with Time Above Range (TAR, >13.9 mmol/L) <5%
Time frame: CGM data collected at the end of the study (week 14 ± 7days).
The frequency of confirmed hypoglycemia
Having symptoms of hypoglycemia and a fingerstick blood glucose measurement of \<4mmol/L.
Time frame: From baseline to the end of the study (week 0-week 14 ± 7days).
Frequency of confirmed nocturnal hypoglycemia
Confirmed hypoglycemia occurring at night
Time frame: From baseline to the end of the study (week 0-week 14 ± 7days).
Frequency of severe hypoglycemia
hypoglycemia that the individual cannot self-treat and requires assistance from another person
Time frame: From baseline to the end of the study (week 0-week 14 ± 7days).
Change in body weight from baseline
Time frame: From baseline to the end of the study (week 0-week 14 ± 7days).
Change in waist circumference from baseline
Time frame: From baseline to the end of the study (week 0-week 14 ± 7days).
Short-Form Health Survey (SF-36)
A score ranging from 0 to 100. Higher scores indicate better health status.
Time frame: At the end of the study (week 14 ± 7days).
Diabetes Treatment Satisfaction Questionnaire (DTSQs) ④ Exploratory Evaluation Indicators
The DTSQs is composed of six items and scored on seven-point response scales ranging from "very satisfied" (assigned a score of 6) to "very unsatisfied" (assigned a score of 0). Higher DTSQs scores indicate greater satisfaction with treatment (range 0 to 36).
Time frame: At the end of the study (week 14 ± 7days).
Changes in the Ambulatory Glucose Profile (AGP) graph obtained from CGM
Time frame: From baseline to the end of the study (week 0-week 14 ± 7days).
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