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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premixed insulin dose optimization group | Active Comparator | The participants in this group will get optimized insulin dosage adjustment on premixed insulin. |
|
| IDegLira once daily injection group | Experimental | The participants in this group will switch from premixed insulin to IDegLira once daily injection therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDegLira | Drug | The participants in this group will be switched to IDegLira once daily injection therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Liu, M.D. | Contact | +86-10-88324105 | liuwei03@bjmu.edu.cn |
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Individual participant data (IPD) could be accessed with proper reason from the PI.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000613158 | IDegLira |
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| Premixed insulin | Drug | The participants in this group will be have optimized premixed insulin regimen. |
|
| 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). |
| D004700 | Endocrine System Diseases |