Comparison of Insulin Aspart With Buffered Regular Insulin and Insulin Lispro in Continuous Subcutaneous Insulin Infusion
A randomized study in type 1 diabetes
- Bruce Bode, MD1,
- Richard Weinstein, MD2,
- David Bell, MD3,
- Janet McGill, MD4,
- Daniel Nadeau, MD5,
- Philip Raskin, MD6,
- Jaime Davidson, MD7,
- Robert Henry, MD8,
- Won-Chin Huang, PHD9 and
- Rickey R. Reinhardt, MD, PHD9
- 1Atlanta Diabetes Associates, Atlanta, Georgia
- 2Diablo Clinical Research, Walnut Creek, California
- 3Kirklin Clinic, Birmingham, Alabama
- 4Washington University, St. Louis, Missouri
- 5Eastern Maine Medical Center, Bangor, Maine
- 6Southwestern Medical Center, Dallas, Texas
- 7Endocrine & Diabetes Associates, Dallas, Texas
- 8VA Medical Center, San Diego, CA
- 9Novo Nordisk Pharmaceuticals, Princeton, New Jersey
OBJECTIVE—To compare the safety and efficacy of insulin aspart (IAsp), buffered regular insulin (BR), and insulin lispro administered by continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes.
RESEARCH DESIGN AND METHODS—After completing a 4-week run-in period with BR, 146 adult patients with type 1 diabetes (with pretrial CSII experience) were randomly assigned (2:2:1) to CSII treatment with IAsp, BR, or lispro for 16 weeks in a multicenter, open-label, randomized, parallel-group study. Bolus insulin doses were administered 30 min before meals (BR) or immediately before meals (IAsp or lispro).
RESULTS—Treatment groups had similar baseline HbA1c (7.3% ±0.7 for IAsp, 7.5% ±0.8 for BR, and 7.3% ±0.7 for lispro). After 16 weeks of treatment, HbA1c values were relatively unchanged from baseline, and the mean changes in baseline HbA1c values were not significantly different between the three groups (0.00 ±0.51, 0.15 ±0.63, and 0.18 ±0.84 for the IAsp, BR, and lispro groups, respectively). The rates of hypoglycemic episodes (blood glucose <50 mg/dl) per patient per month were similar (3.7, 4.8, and 4.4 for the IAsp, BR, and lispro groups, respectively). Clogs/blockages in pumps or infusion sets were infrequent; most subjects (76, 83, and 75% in the IAsp, BR, and lispro groups, respectively) had ≤1 clog or blockage per 4 weeks during the trial.
CONCLUSIONS—Insulin aspart in CSII was as efficacious and well tolerated as BR and lispro and is a suitable insulin for continuous subcutaneous insulin infusion using external pumps.
- BG, blood glucose
- BR, buffered regular insulin
- CSII, continuous subcutaneous insulin infusion
- DCCT, Diabetes Control and Complications Trial
- IAsp, insulin aspart
- MDI, multiple daily injection
- SD, standard deviation
Address correspondence and reprint requests to Bruce W. Bode, MD, Atlanta Diabetes Associates, 77 Collier Rd. NW, Suite 2080, Atlanta, GA 30309. E-mail:.
Received for publication 18 June 2001 and accepted in revised form 21 September 2001.
B.B. and J.M. has received honoraria from Novo Nordisk Pharmaceuticals. D.N. has received honoraria from Minimed. P.R. has received consultantships and/or is on the speaker’s board for Asta Medica, Aventis, Bayer, Bristol Myers Squibb, Eli Lilly, Merck, Novo Nordisk, Pfizer, Sanwa, SmithKline Beecham, Takeda America, and Therasense and holds stock options in Therasense. J.A.D. has received consultantships and/or is on the speaker’s board for Bayer Pharmaceuticals, Bristol Myers Squibb, Eli Lilly, Merck, BioControl Technologies, Pfizer, Novo Nordisk, Dura Pharmaceuticals, SmithKline Beecham, and Takeda. R.H. is a paid consultant for Novo Nordisk.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
- DIABETES CARE