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The investigators aimed to compare efficacy and safety of IGlarLixi and insulin glargine plus dulaglutide as intensification from basal insulin with metformin, in the absence of head-to-head trials.
Fixed-dose combinations of insulin glargine/lixisenatide (IGlarLixi) or insulin glargine plus dulaglutide constitute treatment intensification in type 2 diabetes mellitus (T2D). The investigators aimed to compare efficacy and safety of IGlarLixi and insulin glargine plus dulaglutide as intensification from basal insulin with metformin, in the absence of head-to-head trials. Treatments were compared in terms of glycated hemoglobin (HbA1c), fasting plasma glucose (FPG) change from baseline, and variables from continuous glucose monitoring (CGM) system; in addition to safety issues on hypoglycemia and changes in weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iGlar/Lixi | Active Comparator | Switching to IGlarLixi from insulin glargine iGlar/Lixi starts with the following doses depending on the existing insulin glargine dose: 1) insulin glargine <20 unit/day = iGlar/Lixi 10 unit/day, 2) insulin glargine >=20 unit/day = iGlar/Lixi 20 unit/day. Training to increase the iGlar/Lixi dosage every 3 days to meet the target fasting blood glucose level to 80~130 mg/day |
|
| Dulaglutide plus insulin glargine | Active Comparator | Adding Dulaglutide to insulin glargine. Keep insulin glargine and dulaglutide start at 0.75 mg per week and increase to 1.5 mg per week after 1 month with evaluating compliance and tolerability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGlarLixi | Drug | Changing to iGlarLixi from insulin glargine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glycated hemoglobin (HbA1c) | HbA1c will be measured at baseline and week 12 | Baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fasting plasma glucose (FPG) | Comparison of FPG changes in week 12 from baseline between the two groups | Baseline, week 12 |
| Changes in glucose time in range (TIR) | Comparison of %TIR changes in week 12 from baseline between the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eu Jeong Ku, MD, PhD | Chungbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheonju | North Chungcheong | 28644 | South Korea |
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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 |
|---|---|
| C555680 | dulaglutide |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Dulaglutide |
| Drug |
Add dulaglutide to insulin glargine |
|
|
| Baseline, week 12 |
| Changes in glucose time above range (TAR) | Comparison of %TAR changes in week 12 from baseline between the two groups | Baseline, week 12 |
| Changes in glucose time below range (TBR) | Comparison of %TBR changes in week 12 from baseline between the two groups | Baseline, week 12 |
| Incidence of hypoglycemia | Comparison of the incidence of hypoglycemia between the two groups | Baseline, week 12 |
| Changes in weight | Comparison of weight changes in week 12 from baseline between the two | Baseline, week 12 |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |