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Diabetes Care 28:260-265, 2005
© 2005 by the American Diabetes Association, Inc.

Clinical Care/Education/Nutrition
Original Article

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 and Alan Garber, MD7 for the INITIATE Study Group*

1 University of Texas, Southwestern Medical Center, Dallas, Texas
2 Novo Nordisk, Princeton, New Jersey
3 Baylor University Medical Center, Dallas, Texas
4 National Research Institute, Los Angeles, California
5 Hershey Medical Center, Pennsylvania State College of Medicine, Hershey, Pennsylvania
6 Atlanta Diabetes Association, Atlanta, Georgia
7 Baylor 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

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%.

Abbreviations: FPG, fasting plasma glucose • OAD, oral antidiabetic drug • TZD, thiazolidinedione • SMPG, self-measured plasma glucose


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