Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes Insufficiently Controlled by Insulin Glargine and Metformin Combination Therapy

Conditions
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Type 2 Diabetes Mellitus, Glucose, High Blood

Intervention / Treatment
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* Drug: IGlarLixi
* Drug: Dulaglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Patient with type 2 diabetes, treated with basal insulin plus metformin (maximum tolerated dosage) for at least 12 weeks Patient accepting to participant to this study Exclusion Criteria: Pregnant or breastfeeding woman severe renal dysfunction (eGFR <60 ml/min/1.73m2) chronic or acute hepatic disorder (HBV or HCV hepatitis, liver cirrhosis etc.) (AST/ALT > 2.5*ULN) Prescription such as immunosuppressant agents, glucocorticoids Active anti-cancer treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iGlar/Lixi<br>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 | Drug: IGlarLixi<br>* Changing to iGlarLixi from insulin glargine<br>|
| Active Comparator: Dulaglutide plus insulin glargine<br>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. | Drug: Dulaglutide<br>* Add dulaglutide to insulin glargine<br>* Other names: Insulin Glargine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glycated hemoglobin (HbA1c) | HbA1c will be measured at baseline and week 12 | Baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IGlarLixi, Dulaglutide, Continuous glucose monitoring system, Type 2 diabetes mellitus