TY  - BOOK
AU  - Ratner, Robert E
TI  - Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. []
SN  - 0149-5992
PY  - 2014///
KW  - *Diabetes Mellitus, Type 2/dt [Drug Therapy]
KW  - *Glucagon-Like Peptide 1/aa [Analogs & Derivatives]
KW  - *Hypoglycemic Agents/ad [Administration & Dosage]
KW  - *Insulin Lispro/ad [Administration & Dosage]
KW  - *Insulin, Long-Acting/ad [Administration & Dosage]
KW  - *Insulin/ad [Administration & Dosage]
KW  - Administration, Oral
KW  - Adult
KW  - Aged
KW  - Blood Glucose/de [Drug Effects]
KW  - Diabetes Mellitus, Type 2/me [Metabolism]
KW  - Drug Administration Schedule
KW  - Drug Substitution
KW  - Drug Therapy, Combination
KW  - Female
KW  - Glucagon-Like Peptide 1/ad [Administration & Dosage]
KW  - Hemoglobin A, Glycosylated/an [Analysis]
KW  - Humans
KW  - Male
KW  - Meals
KW  - Metformin/ad [Administration & Dosage]
KW  - Middle Aged
KW  - Receptors, Glucagon/ag [Agonists]
KW  - Thiazolidinediones/ad [Administration & Dosage]
KW  - Treatment Outcome
KW  - MedStar Health Research Institute
KW  - Clinical Trial, Phase III
KW  - Journal Article
KW  - Multicenter Study
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N1  - Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
N2  - CONCLUSIONS: Weekly albiglutide is a simpler therapeutic option than thrice-daily lispro for advancing basal insulin glargine therapy, resulting in comparable HbA1c reduction with weight loss and lower hypoglycemia risk.Copyright � 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered; OBJECTIVE: GLP-1 receptor agonists may provide an alternative to prandial insulin for advancing basal insulin therapy. Harmony 6 was a randomized, open-label, active-controlled trial testing once-weekly albiglutide vs. thrice-daily prandial insulin lispro as an add-on to titrated once-daily insulin glargine; RESEARCH DESIGN AND METHODS: Patients taking basal insulin (with or without oral agents) with HbA1c 7-10.5% (53-91 mmol/mol) entered a glargine standardization period, followed by randomization to albiglutide, 30 mg weekly (n = 282), subsequently uptitrated to 50 mg, if necessary, or thrice-daily prandial lispro (n = 281) while continuing metformin and/or pioglitazone. Glargine was titrated to fasting plasma glucose of <5.6 mmol/L, and lispro was adjusted based on glucose monitoring. The primary end point was the difference in the HbA1c change from baseline at week 26; RESULTS: At week 26, HbA1c decreased from baseline by -0.82 +/- SE 0.06% (9.0 mmol/mol) with albiglutide and -0.66 +/- 0.06% (7.2 mmol/mol) with lispro; treatment difference, -0.16% (95% CI -0.32 to 0.00; 1.8 mmol/mol; P < 0.0001), meeting the noninferiority end point (margin, 0.4%). Weight decreased with albiglutide but increased with lispro (-0.73 +/- 0.19 kg vs. +0.81 +/- 0.19 kg). The mean glargine dose increased from 47 to 53 IU (albiglutide) and from 44 to 51 IU (lispro). Adverse events for albiglutide versus lispro included severe hypoglycemia (0 vs. 2 events), documented symptomatic hypoglycemia (15.8% vs. 29.9%), nausea (11.2% vs. 1.4%), vomiting (6.7% vs. 1.4%), and injection site reactions (9.5% vs. 5.3%)
UR  - http://dx.doi.org/10.2337/dc14-0001
ER  -