title: DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes.
abstract: BACKGROUND
  We wanted to understand the effects of once-weekly vs. twice-daily glucagon-like peptide-1 receptor agonism for treatment of patients with type 2 diabetes.
  
  
  OBJECTIVE
  The objective of the study was to compare effects of exenatide once weekly (ExQW) and exenatide twice daily (ExBID) on glycemic control, body weight, and safety.
  
  
  METHODS
  This was a 24-wk, randomized, open-label, comparator-controlled study.
  
  
  METHODS
  The study was conducted at 43 sites in the United States.
  
  
  METHODS
  The study population was 252 intent-to-treat patients with type 2 diabetes [baseline (mean ± SD): glycosylated hemoglobin (HbA1c) 8.4 ± 1.2%, fasting plasma glucose 171 ± 47 mg/dl, weight 96 ± 20 kg] that were drug naïve (19%) or previously treated with one (47%) or multiple (35%) oral antidiabetic medications.
  
  
  METHODS
  Interventions included ExQW 2 mg for 24 wk or ExBID 5 μg for 4 wk followed by ExBID 10 μg for 20 wk.
  
  
  METHODS
  The change in HbA1c from baseline to wk 24 was measured.
  
  
  RESULTS
  At 24 wk, ExQW produced significantly greater changes from baseline (least squares mean ± SE) vs. ExBID in HbA1c (-1.6 ± 0.1% vs. -0.9 ± 0.1%; P < 0.0001) and fasting plasma glucose (-35 ± 5 mg/dl vs. -12 ± 5 mg/dl; P = 0.0008). Similar reductions in mean body weight from baseline to wk 24 were observed in both groups (-2.3 ± 0.4 kg and -1.4 ± 0.4 kg). Both treatments were generally well tolerated. Transient and predominantly mild to moderate nausea, the most frequent adverse event, was less common with ExQW (14%) than with ExBID (35%). Injection-site reactions were infrequent, but more common with ExQW. No major hypoglycemia occurred.
  
  
  CONCLUSIONS
  Continuous glucagon-like peptide-1 receptor agonism with ExQW resulted in superior glycemic control, with less nausea, compared with ExBID in patients with type 2 diabetes. Both groups lost weight.
authors.affiliation: Texas Diabetes and Endocrinology, 6500 North Mopac Expressway, Building 3, Suite 200, Austin, Texas 78731, USA. tblevins@texasdiabetes.com
authors.forename: Thomas
authors.initials: T
authors.lastname: Blevins
authors.forename: John
authors.initials: J
authors.lastname: Pullman
authors.forename: Jaret
authors.initials: J
authors.lastname: Malloy
authors.forename: Ping
authors.initials: P
authors.lastname: Yan
authors.forename: Kristin
authors.initials: K
authors.lastname: Taylor
authors.forename: Christine
authors.initials: C
authors.lastname: Schulteis
authors.forename: Michael
authors.initials: M
authors.lastname: Trautmann
authors.forename: Lisa
authors.initials: L
authors.lastname: Porter
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism*; D001794:Blood Pressure / Q000502:physiology; D001835:Body Weight / Q000502:physiology; D002851:Chromatography, High Pressure Liquid; D003131:Combined Modality Therapy; D003692:Delayed-Action Preparations; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000178:diet therapy / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D004797:Enzyme-Linked Immunosorbent Assay; D000077270:Exenatide; D005081:Exercise Therapy; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D014688:Venoms / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D015431:Weight Loss / Q000187:drug effects; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D003692:Delayed-Action Preparations; D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D010455:Peptides; D014688:Venoms