DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks.
OBJECTIVE
In the Diabetes Therapy Utilization: Researching Changes in A1C, Weight and Other Factors Through Intervention with Exenatide Once Weekly (DURATION-1) study, the safety and efficacy of 30 weeks of treatment with the glucagon-like peptide-1 receptor agonist exenatide once weekly (exenatide QW; 2 mg) was compared with exenatide BID in 295 patients with type 2 diabetes. We now report the safety and efficacy of exenatide QW in 1) patients who continued treatment for an additional 22 weeks (52 weeks total) and 2) patients who switched from exenatide BID to exenatide QW after 30 weeks.


METHODS
In this randomized, multicenter, comparator-controlled, open-label trial, 258 patients entered the 22-week open-ended assessment phase (n = 128 QW-only; n = 130 BID-->QW). A1C, fasting plasma glucose (FPG), body weight, blood pressure, fasting lipids, safety, and tolerability were assessed.


RESULTS
Patients continuing exenatide QW maintained A1C improvements through 52 weeks (least squares mean -2.0% [95% CI -2.1 to -1.8%]). Patients switching from exenatide BID to exenatide QW achieved further A1C improvements; both groups exhibited the same A1C reduction and mean A1C (6.6%) at week 52. At week 52, 71 and 54% of all patients achieved A1C <7.0% and <or=6.5%, respectively. In both treatment arms, FPG was reduced by >40 mg/dl, and body weight was reduced by >4 kg after 52 weeks. Nausea occurred less frequently in this assessment period and was predominantly mild. No major hypoglycemia was observed.


CONCLUSIONS
Exenatide QW elicited sustained improvements in glycemic control and body weight through 52 weeks of treatment. Patients switching to exenatide QW experienced further improvements in A1C and FPG, with sustained weight loss.
Buse
John B
JB
Division of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA. jbuse@med.unc.edu
Drucker
Daniel J
DJ
Taylor
Kristin L
KL
Kim
Terri
T
Walsh
Brandon
B
Hu
Hao
H
Wilhelm
Ken
K
Trautmann
Michael
M
Shen
Larry Z
LZ
Porter
Lisa E
LE
D001786:Blood Glucose / Q000187:drug effects*; D001794:Blood Pressure / Q000187:drug effects; D000077270:Exenatide; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D008055:Lipids / Q000097:blood; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D014688:Venoms / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D015431:Weight Loss / Q000187:drug effects*
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D008055:Lipids; D010455:Peptides; D014688:Venoms; D000077270:Exenatide