Comparative glycemic control, safety and patient ratings for a new 4 mm x 32G insulin pen needle in adults with diabetes.
OBJECTIVE
Pen needles (PN) for subcutaneous insulin therapy have become smaller; 5 mm PNs are now the shortest in use. We evaluated the safety, efficacy and patient ratings of a new 4 mm x 32 gauge (G) PN.


METHODS
Subjects with type 1 and type 2 diabetes and HbA1c 5.5% to 9.5% participated in a randomized non-inferiority cross-over trial, at four U.S. centers. Subjects used 4 mm x 32G PNs and either 5 mm x 31G PNs (4/5 mm) or 8 mm x 31G PNs (4/8 mm) in two, 3-week treatment periods; order of needle use was controlled. Subjects were either 'low dose' or 'regular dose' users (highest single insulin dose <or= 20 units and 21-40 units, respectively). Percent absolute change in serum fructosamine (% |Delta Fru|) was the primary endpoint; unexplained, severe hypo- or hyperglycemia was a secondary measure. Leakage at injection sites and pain measured by visual analog scale were tertiary measures. Equivalent glycemic control was defined á priori as % |Delta Fru| (including 95% CI) within 20%; 40 subjects per subgroup provides 90% power at alpha = 0.05.


BACKGROUND
The study was registered on clinicaltrials.gov (identifier: NCT00928057).


RESULTS
Of 173 subjects randomized, 168 completed the study, and 163 were included in the fructosamine analyses--83 and 80 in the 4/5 mm and 4/8 mm groups, respectively. Subjects were 56% male, mean 52.6 yrs, 63% type 2. Baseline HbA1c = 7.5 +/- 1.0% and fructosamine 301 +/- 55.1 micromol/L. Mean % |Delta Fru| was 4.9% (95% CI 3.8, 6.0) and 5.5% (4.5, 6.4), respectively, for the 4/5 mm and 4/8 mm groups, meeting glycemic equivalence criteria; results were similar in both dose groups. The median |Delta Fru| was 11.0 micromol/L (8.0, 13.0) and 13.5 micromol/L (9.8, 18.0) for the 4/5 mm and 4/8 mm groups, respectively. Unexplained, severe hypo- and hyperglycemic episodes were infrequent and not different between PNs. The 4 mm PN was rated significantly less painful and preferred by approximately 2/3 of subjects (p < 0.01). All three PNs had similar reported injection site leakage.


CONCLUSIONS
The study was of relatively short duration, in adults in the U.S. Further trials in other patients (e.g., GLP-1 users, pediatrics, obese) should be performed.


CONCLUSIONS
The 4 mm x 32G PN provided equivalent glycemic control compared to 31G, 5 mm and 8 mm PNs with reduced pain, no difference in insulin leakage and was preferred by patients.
Hirsch
Laurence J
LJ
Becton, Dickinson and Company, Franklin Lakes, NJ 07417, USA. laurence_hirsch@bd.com
Gibney
Michael A
MA
Albanese
John
J
Qu
Shankang
S
Kassler-Taub
Kenneth
K
Klaff
Leslie J
LJ
Bailey
Timothy S
TS
D000293:Adolescent; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D005260:Female; D038321:Glycemic Index / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007271:Injections, Intradermal / Q000295:instrumentation*; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D017060:Patient Satisfaction; D014481:United States; D055815:Young Adult
D007004:Hypoglycemic Agents; D007328:Insulin