Initiating Insulin Therapy in Type 2 Diabetes
A comparison of biphasic and basal insulin analogs
- Philip Raskin, MD1,
- Elsie Allen, MD2,
- Priscilla Hollander, MD3,
- Andrew Lewin, MD4,
- Robert A. Gabbay, MD, PHD5,
- Peter Hu, PHD2,
- Bruce Bode, MD6,
- Alan Garber, MD7 and
- for the INITIATE Study Group*
- 1University of Texas, Southwestern Medical Center, Dallas, Texas
- 2Novo Nordisk, Princeton, New Jersey
- 3Baylor University Medical Center, Dallas, Texas
- 4National Research Institute, Los Angeles, California
- 5Hershey Medical Center, Pennsylvania State College of Medicine, Hershey, Pennsylvania
- 6Atlanta Diabetes Association, Atlanta, Georgia
- 7Baylor College of Medicine, Houston, Texas
- Address correspondence and reprint requests to Philip Raskin, MD, Department of Internal Medicine, Southwestern Medical Center at Dallas, Dallas, TX 75390-8858. E-mail: philip.raskin{at}utsouthwestern.edu
Abstract
OBJECTIVE—Safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 70/30, prebreakfast and presupper) were compared with once-daily insulin glargine in type 2 diabetic subjects inadequately controlled on oral antidiabetic drugs (OADs).
RESEARCH DESIGN AND METHODS—This 28-week parallel-group study randomized 233 insulin-naive patients with HbA1c values ≥8.0% on >1,000 mg/day metformin alone or in combination with other OADs. Metformin was adjusted up to 2,550 mg/day before insulin therapy was initiated with 5–6 units BIAsp 70/30 twice daily or 10–12 units glargine at bedtime and titrated to target blood glucose (80–110 mg/dl) by algorithm-directed titration.
RESULTS—A total of 209 subjects completed the study. At study end, the mean HbA1c value was lower in the BIAsp 70/30 group than in the glargine group (6.91 ± 1.17 vs. 7.41 ± 1.24%, P < 0.01). The HbA1c reduction was greater in the BIAsp 70/30 group than in the glargine group (−2.79 ± 0.11 vs. −2.36 ± 0.11%, respectively; P < 0.01), especially for subjects with baseline HbA1c >8.5% (−3.13 ± 1.63 vs. −2.60 ± 1.50%, respectively; P < 0.05). More BIAsp 70/30–treated subjects reached target HbA1c values than glargine-treated subjects (HbA1c ≤6.5%: 42 vs. 28%, P < 0.05; HbA1c <7.0%: 66 vs. 40%, P < 0.001). Minor hypoglycemia (episodes/year) was greater in the BIAsp 70/30 group than in the glargine group (3.4 ± 6.6 and 0.7 ± 2.0, respectively; P < 0.05). Weight gain and daily insulin dose at study end were greater for BIAsp 70/30–treated subjects than for glargine-treated subjects (weight gain: 5.4 ± 4.8 vs. 3.5 ± 4.5 kg, P < 0.01; insulin dose: 78.5 ± 39.5 and 51.3 ± 26.7 units/day, respectively).
CONCLUSIONS—In subjects with type 2 diabetes poorly controlled on OADs, initiating insulin therapy with twice-daily BIAsp 70/30 was more effective in achieving HbA1c targets than once-daily glargine, especially in subjects with HbA1c >8.5%.
- FPG, fasting plasma glucose
- OAD, oral antidiabetic drug
- TZD, thiazolidinedione
- SMPG, self-measured plasma glucose
Footnotes
- *
↵* A complete listing of INITIATE Study Group members can be found in the appendix.
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P.R. is a member of an advisory panel for and has received honoraria, consulting fees, and research support from Novo Nordisk. A.L. has received honoraria from Novo Nordisk. R.A.G. has received research support from Novo Nordisk and has participated in speakers’ bureaus for Novo Nordisk, GlaxoSmithKline, Pfizer, Aventis, and Merck. B.B. is a member of an advisory board for and has received honoraria and grant/research support from Novo Nordisk. A.G. has received grant/research support from Bristol-Myers Squibb, GlaxoSmithKline, Novo Nordisk, Schering-Plough, Novartis, Roche, Astra-Zeneca, Merck, and Fujisawa; has acted as a consultant for Bristol-Myers Squibb, GlaxoSmithKline, and Novo Nordisk; and has participated in speakers’ bureaus for Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Novo Nordisk, Pfizer, Wyeth-Ayerst, and Aventis.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
See accompanying editorial, p. 494.
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- Accepted November 2, 2004.
- Received October 21, 2004.
- DIABETES CARE
