Abstract
Objective
To determine whether insulin delivered via a 4-mm × 32-gauge pen needle (PN) provides
equivalent glycemic control as 8-mm × 31-gauge and 12.7-mm × 29-gauge PNs in obese
(body mass index ≥30) patients with diabetes.
Patients and Methods
This prospective, multicenter, randomized, open-label, 2-period, crossover, equivalence,
home-based study was conducted from October 26, 2010, through May 31, 2012. After
a 3-week wash-in period, eligible patients aged 18 to 80 years with a hemoglobin A1c (HbA1c) level of 5.5% to 9.5% (37-80 mmol/mol) were randomized to compare either 4- vs 8-mm
PNs or 4- vs 12.7-mm PNs, using each of the 2 assigned PNs for 12 weeks in random
order. The primary outcome was change in HbA1c level, with equivalence limits of ±0.4%.
Results
The 274 patients randomized (mean ± SD age, 56.7±11.0 years) had a mean ± SD body
mass index of 37.0±6.1 (range, 29.1-59.9) and took up to 350 U of insulin daily; 226
patients were included in the modified intention-to-treat analysis. Mean (95% CI)
changes in HbA1c levels with the 4-mm PN were –0.08% (–0.21 to 0.06) and –0.10% (–0.19 to 0.00) vs
the 8- and 12.7-mm PNs, respectively, within equivalence margins. The 4-mm PN was
less painful than the larger PNs (P<.05), with similar leakage rates reported (4.1%-4.3%). Patients preferred the 4-mm
PN over the 12.7-mm PN (P<.05) but not significantly vs the 8-mm PN. There were no differences between PNs
in insulin doses and hypoglycemic or hyperglycemic adverse event rates.
Conclusion
The 4-mm × 32-gauge PN provides equivalent glycemic control as 8- and 12.7-mm PNs
in obese patients with diabetes, with less pain and no increase in leakage. Shorter
PNs should be considered in all insulin-requiring patients with diabetes, including
those who are obese.
Trial Registration
clinicaltrials.gov Identifier: NCT01231984
Abbreviations and Acronyms:
BMI (body mass index), HbA1c (hemoglobin A1c), mITT (modified intention-to-treat analysis), PN (pen needle), T1DM (type 1 diabetes mellitus), T2DM (type 2 diabetes mellitus), TDD (total daily dose (of insulin))To read this article in full you will need to make a payment
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Article Info
Publication History
Published online: February 05, 2015
Footnotes
Grant Support: Park Nicollet Institute received a research grant on behalf of Richard M. Bergenstal MD from BD (Becton Dickinson and Company, Franklin Lakes, NJ) to conduct this trial.
Potential Competing Interests: Dr Bergenstal has served on the advisory panel for Abbott Diabetes Care, AstraZeneca/Bristol-Myers Squibb, Bayer HealthCare, Boehringer Ingelheim, Eli Lilly, Halozyme Therapeutics, Hygieia, Johnson & Johnson, Medtronic, Novo Nordisk, Roche Pharmaceuticals, and Sanofi; has served as a consultant for Abbott Diabetes Care, AstraZeneca/Bristol-Myers Squibb, Bayer HealthCare, Becton Dickinson Medical Diabetes Care, Boehringer Ingelheim, Calibra Medical, Dexcom, Eli Lilly, Halozyme Therapeutics, Hygieia, Johnson & Johnson, Medtronic, Merck, Novo Nordisk, Roche Pharmaceuticals, Sanofi, and Takeda Pharmaceuticals; has received research support from AstraZeneca, Bayer HealthCare, Becton Dickinson Diabetes Care, Boehringer Ingelheim, Calibra Medical, Dexcom, Eli Lilly, Halozyme Therapeutics, Helmsley Charitable Trust, Hygieia, Johnson & Johnson, Medtronic, Merck, Novo Nordisk, Roche Pharmaceuticals, and Sanofi; and has inherited Merck stock. All contracts are with Dr Bergenstal’s nonprofit employer, Park Nicollet Institute; Dr Bergenstal receives no personal compensation. Dr Hirsch, Mr Gibney, and Mr Parvu are employees of BD (Becton, Dickinson and Company, Inc).
Identification
Copyright
© 2015 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.
