Basal-bolus therapy with insulin detemir using the 303 algorithm in the US PREDICTIVE 303 trial.
BACKGROUND
The aim of this study was to compare a simplified patient-driven algorithm (303 Algorithm) to physician-driven adjustments in a subset of 193 patients with type 2 diabetes from the PREDICTIVE 303 study who were using basal-bolus insulin therapy.


METHODS
PREDICTIVE 303 was a 26-week, randomized, phase 4 study, in which subjects were either instructed to adjust their insulin detemir dose every 3 days by +/-3 units if mean fasting plasma glucose (FPG) values were above 110 mg/dL or below 80 mg/dL (303 Algorithm), or had physicians adjust the insulin detemir dose according to usual practice (Standard-of-care).


RESULTS
Patients in both groups achieved similar reductions in glycated hemoglobin (-0.2% and -0.3% for 303 Algorithm and Standard-of care groups, respectively; between groups P=0.60). 303 Algorithm group patients achieved a greater reduction in FPG (-21.3 mg/dL vs. 0.2 mg/dL; between groups P=0.03). Both 303 Algorithm and Standard-of care groups experienced a similar rate of overall hypoglycemia, and similar weight reduction (-1.7 kg and -0.4 kg, respectively; between groups P=0.07). Over 82% of patients in both groups used insulin detemir once daily.


CONCLUSIONS
Adjustments of a once-daily detemir dose by patients using the 303 Algorithm in a basal-bolus setting is equally effective in improving glycemic control in patients with type 2 diabetes compared with physician-directed basal dose adjustments.
Selam
Jean-Louis
JL
Diabetes Research Center, 2492 Walnut Ave, Tustin, California 92780, USA. jlselam@cox.net
Meneghini
Luigi F
LF
D000368:Aged; D000465:Algorithms; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D015190:Blood Glucose Self-Monitoring; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D010819:Physician's Role; D017410:Practice Guidelines as Topic; D012449:Safety; D012646:Self Administration / Q000379:methods*; D016896:Treatment Outcome; D014481:United States
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007328:Insulin; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting