Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial.
Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial.
- 2019
Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
CONCLUSIONS: Switching to iGlarLixi improves glucose control for patients with type 2 diabetes insufficiently controlled on a maximum tolerated dose of a GLP-1 RA plus oral antihyperglycemic agents. Copyright (c) 2019 by the American Diabetes Association. OBJECTIVE: Fixed-ratio combinations of basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1 RA) allow concomitant administration of two proven complementary injectable therapies for type 2 diabetes. This study investigated switching to a titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) in patients with type 2 diabetes receiving daily or weekly GLP-1 RA therapy. RESEARCH DESIGN AND METHODS: LixiLan-G, a randomized, open-label, 26-week trial, comparing switching to iGlarLixi versus continuing prior GLP-1 RA in patients with type 2 diabetes and HbA1c 7-9% (53-75 mmol/mol) taking maximum tolerated doses of a GLP-1 RA daily (60% on liraglutide once daily or exenatide twice daily) or weekly (40% on dulaglutide, exenatide extended release, or albiglutide) with metformin with or without pioglitazone and with or without sodium-glucose cotransporter 2 inhibitors. Adherence to randomized treatment was closely monitored throughout the study. RESULTS: iGlarLixi (n = 257) reduced HbA1c more than continued GLP-1 RA therapy (n = 257) from a baseline 7.8% (62 mmol/mol) in both to 6.7% (50 mmol/mol) and 7.4% (57 mmol/mol), respectively, at 26 weeks (least squares mean difference -0.6%; P < 0.0001). More iGlarLixi patients achieved HbA1c <7% (53 mmol/mol) (62% vs. 26%; P < 0.0001) and the composite of HbA1c <7% without documented symptomatic hypoglycemia (<54 mg/dL). Nausea and vomiting rates as well as numbers of documented symptomatic hypoglycemia events per patient-year were generally low but greater with iGlarLixi versus continued GLP-1 RA therapy.
English
0149-5992
10.2337/dc19-1357 [doi] dc19-1357 [pii]
*Diabetes Mellitus, Type 2/dt [Drug Therapy]
*Glucagon-Like Peptide-1 Receptor/ag [Agonists]
*Hypoglycemic Agents/ad [Administration & Dosage]
*Insulin Glargine/ad [Administration & Dosage]
*Peptides/ad [Administration & Dosage]
Adult
Blood Glucose/de [Drug Effects]
Diabetes Mellitus, Type 2/bl [Blood]
Diabetes Mellitus, Type 2/co [Complications]
Drug Administration Schedule
Drug Combinations
Drug Substitution
Drug Therapy, Combination
Exenatide/ad [Administration & Dosage]
Female
Glucagon-Like Peptides/aa [Analogs & Derivatives]
Glucagon-Like Peptides/ad [Administration & Dosage]
Glycated Hemoglobin A/de [Drug Effects]
Humans
Hypoglycemia/dt [Drug Therapy]
Hypoglycemia/et [Etiology]
Immunoglobulin Fc Fragments/ad [Administration & Dosage]
Male
Metformin/ad [Administration & Dosage]
Middle Aged
Pioglitazone/ad [Administration & Dosage]
Recombinant Fusion Proteins/ad [Administration & Dosage]
Sodium-Glucose Transporter 2 Inhibitors/ad [Administration & Dosage]
Treatment Outcome
MedStar Health Research Institute
Journal Article
Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
CONCLUSIONS: Switching to iGlarLixi improves glucose control for patients with type 2 diabetes insufficiently controlled on a maximum tolerated dose of a GLP-1 RA plus oral antihyperglycemic agents. Copyright (c) 2019 by the American Diabetes Association. OBJECTIVE: Fixed-ratio combinations of basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1 RA) allow concomitant administration of two proven complementary injectable therapies for type 2 diabetes. This study investigated switching to a titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) in patients with type 2 diabetes receiving daily or weekly GLP-1 RA therapy. RESEARCH DESIGN AND METHODS: LixiLan-G, a randomized, open-label, 26-week trial, comparing switching to iGlarLixi versus continuing prior GLP-1 RA in patients with type 2 diabetes and HbA1c 7-9% (53-75 mmol/mol) taking maximum tolerated doses of a GLP-1 RA daily (60% on liraglutide once daily or exenatide twice daily) or weekly (40% on dulaglutide, exenatide extended release, or albiglutide) with metformin with or without pioglitazone and with or without sodium-glucose cotransporter 2 inhibitors. Adherence to randomized treatment was closely monitored throughout the study. RESULTS: iGlarLixi (n = 257) reduced HbA1c more than continued GLP-1 RA therapy (n = 257) from a baseline 7.8% (62 mmol/mol) in both to 6.7% (50 mmol/mol) and 7.4% (57 mmol/mol), respectively, at 26 weeks (least squares mean difference -0.6%; P < 0.0001). More iGlarLixi patients achieved HbA1c <7% (53 mmol/mol) (62% vs. 26%; P < 0.0001) and the composite of HbA1c <7% without documented symptomatic hypoglycemia (<54 mg/dL). Nausea and vomiting rates as well as numbers of documented symptomatic hypoglycemia events per patient-year were generally low but greater with iGlarLixi versus continued GLP-1 RA therapy.
English
0149-5992
10.2337/dc19-1357 [doi] dc19-1357 [pii]
*Diabetes Mellitus, Type 2/dt [Drug Therapy]
*Glucagon-Like Peptide-1 Receptor/ag [Agonists]
*Hypoglycemic Agents/ad [Administration & Dosage]
*Insulin Glargine/ad [Administration & Dosage]
*Peptides/ad [Administration & Dosage]
Adult
Blood Glucose/de [Drug Effects]
Diabetes Mellitus, Type 2/bl [Blood]
Diabetes Mellitus, Type 2/co [Complications]
Drug Administration Schedule
Drug Combinations
Drug Substitution
Drug Therapy, Combination
Exenatide/ad [Administration & Dosage]
Female
Glucagon-Like Peptides/aa [Analogs & Derivatives]
Glucagon-Like Peptides/ad [Administration & Dosage]
Glycated Hemoglobin A/de [Drug Effects]
Humans
Hypoglycemia/dt [Drug Therapy]
Hypoglycemia/et [Etiology]
Immunoglobulin Fc Fragments/ad [Administration & Dosage]
Male
Metformin/ad [Administration & Dosage]
Middle Aged
Pioglitazone/ad [Administration & Dosage]
Recombinant Fusion Proteins/ad [Administration & Dosage]
Sodium-Glucose Transporter 2 Inhibitors/ad [Administration & Dosage]
Treatment Outcome
MedStar Health Research Institute
Journal Article