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Clinical Trial Details

Trial ID: L5690
Source ID: NCT06408532
Associated Drug: Ideglira
Title: The Efficacy and Safety of Insulin Degludec/Liraglutide Combination (IDegLira) in Patients With Type 2 Diabetes
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: IDegLira|DRUG: Premixed insulin
Outcome Measures: Primary: Hemoglobin A1c (HbA1c), The change in glycated hemoglobin levels from baseline at the end of the study, From baseline to the end of the study (week 0-week 14 ± 7days). | Secondary: Time in Range (TIR, 3.9-10.0 mmol/L) obtained from Continuous Glucose Monitoring (CGM), CGM data collected at the end of the study (week 14 ± 7days).|Time in Tight Range (TTIR, 3.9-7.8 mmol/L), CGM data collected at the end of the study (week 14 ± 7days).|Glucose Management Indicator (GMI), 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), 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), CGM data collected at the end of the study (week 14 ± 7days).|Percentage of patients with TIR (3.9-10 mmol/L) >70%, 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., 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, 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%, 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%, 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%, 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%, 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., From baseline to the end of the study (week 0-week 14 ± 7days).|Frequency of confirmed nocturnal hypoglycemia, Confirmed hypoglycemia occurring at night, 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, From baseline to the end of the study (week 0-week 14 ± 7days).|Change in body weight from baseline, From baseline to the end of the study (week 0-week 14 ± 7days).|Change in waist circumference from baseline, 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., 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)., At the end of the study (week 14 ± 7days).|Changes in the Ambulatory Glucose Profile (AGP) graph obtained from CGM, From baseline to the end of the study (week 0-week 14 ± 7days).
Sponsor/Collaborators: Sponsor: Peking University People's Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 256
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-30
Completion Date: 2025-02-28
Results First Posted:
Last Update Posted: 2024-05-10
Locations:
URL: https://clinicaltrials.gov/show/NCT06408532