Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial.

MedStar author(s):
Citation: Diabetes Care. 39(11):1972-1980, 2016 NovPMID: 27650977Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Diabetes Mellitus, Type 2/dt [Drug Therapy] | *Hypoglycemic Agents/ad [Administration & Dosage] | *Insulin Glargine/tu [Therapeutic Use] | *Peptides/tu [Therapeutic Use] | Aged | Blood Glucose/me [Metabolism] | Body Mass Index | Body Weight | Dose-Response Relationship, Drug | Drug Combinations | Drug Evaluation, Preclinical | Endpoint Determination | Female | Hemoglobin A, Glycosylated/me [Metabolism] | Humans | Hypoglycemic Agents/tu [Therapeutic Use] | Insulin Glargine/ad [Administration & Dosage] | Insulin/tu [Therapeutic Use] | Male | Metformin/tu [Therapeutic Use] | Middle Aged | Peptides/ad [Administration & Dosage] | Treatment OutcomeYear: 2016Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0149-5992
Name of journal: Diabetes careAbstract: CONCLUSIONS: Compared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes.Copyright c 2016 by the American Diabetes Association.OBJECTIVE: This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents.RESEARCH DESIGN AND METHODS: After a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m<sup>2</sup>) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/mol) up to a maximum dose of 60 units/day. The primary outcome was change in HbA<sub>1c</sub> levels at 30 weeks.RESULTS: HbA<sub>1c</sub> decreased from 8.5% (69 mmol/mol) to 8.1% (65 mmol/mol) during the run-in period. After randomization, iGlarLixi showed greater reductions in HbA<sub>1c</sub> from baseline compared with iGlar (-1.1% vs. -0.6%, P < 0.0001), reaching a mean final HbA<sub>1c</sub> of 6.9% (52 mmol/mol) compared with 7.5% (58 mmol/mol) for iGlar. HbA<sub>1c</sub> <7.0% (53 mmol/mol) was achieved in 55% of iGlarLixi patients compared with 30% on iGlar. Mean body weight decreased by 0.7 kg with iGlarLixi and increased by 0.7 kg with iGlar (1.4 kg difference, P < 0.0001). Documented symptomatic hypoglycemia (<70 mg/dL) was comparable between groups. Mild gastrointestinal adverse effects were very low but more frequent with iGlarLixi.All authors: Aroda VR, Bellido D, Bergenstal RM, Gonzalez-Galvez G, Guo H, LixiLan-L Trial Investigators, Niemoeller E, Rosenstock J, Souhami E, Takami A, Unger J, Wysham CFiscal year: FY2016Digital Object Identifier: Date added to catalog: 2017-05-24
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 27650977 Available 27650977

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

CONCLUSIONS: Compared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes.

Copyright c 2016 by the American Diabetes Association.

OBJECTIVE: This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents.

RESEARCH DESIGN AND METHODS: After a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m<sup>2</sup>) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/mol) up to a maximum dose of 60 units/day. The primary outcome was change in HbA<sub>1c</sub> levels at 30 weeks.

RESULTS: HbA<sub>1c</sub> decreased from 8.5% (69 mmol/mol) to 8.1% (65 mmol/mol) during the run-in period. After randomization, iGlarLixi showed greater reductions in HbA<sub>1c</sub> from baseline compared with iGlar (-1.1% vs. -0.6%, P < 0.0001), reaching a mean final HbA<sub>1c</sub> of 6.9% (52 mmol/mol) compared with 7.5% (58 mmol/mol) for iGlar. HbA<sub>1c</sub> <7.0% (53 mmol/mol) was achieved in 55% of iGlarLixi patients compared with 30% on iGlar. Mean body weight decreased by 0.7 kg with iGlarLixi and increased by 0.7 kg with iGlar (1.4 kg difference, P < 0.0001). Documented symptomatic hypoglycemia (<70 mg/dL) was comparable between groups. Mild gastrointestinal adverse effects were very low but more frequent with iGlarLixi.

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