The DURABLE Trial 24-week Results: Safety and Efficacy of Insulin Lispro Mix 75/25 Versus Insulin Glargine Added to Oral Antihyperglycemic Drugs in Patients with Type 2 Diabetes
- John B. Buse, MD, PhD (jbuse{at}med.unc.edu)1,
- Bruce H.R. Wolffenbuttel, MD, PhD2,
- William H. Herman, MD, MPH3,
- Natalie K. Shemonsky, MD4,
- Honghua H. Jiang, PhD5,
- Jessie L. Fahrbach, MD5,
- Jamie L. Scism-Bacon, PhD5 and
- Sherry A. Martin, MD5
- 1Division of Endocrinology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA
- 2Endocrinology & Metabolism, University Medical Center, Groningen and University of Groningen, The Netherlands
- 3Internal Medicine and Epidemiology, University of Michigan, Ann Arbor, MI, USA
- 4Desert Oasis Health Care, Inc., Palm Springs, CA, USA
- 5US Medical Division, Lilly USA, LLC, Indianapolis, Indiana
Abstract
Objective: To compare the ability of two starter insulin regimens to achieve glycemic control in a large, ethnically diverse population with type 2 diabetes.
Research design and methods: During the initiation phase of the DURABLE trial, patients were randomized to twice-daily lispro mix 75/25 (LM75/25; 75% lispro protamine suspension, 25% lispro) (n = 1045) or daily glargine (GL) (n = 1046) with continuation of pre-study oral antihyperglycemic drugs.
Results: Baseline A1C was similar (LM75/25: 9.1±1.3%; GL: 9.0±1.2%; P = 0.414). At 24 weeks, LM75/25 patients had lower A1C than GL (7.2±1.1 vs. 7.3±1.1%, P = 0.005), greater A1C reduction (−1.8±1.3 vs. −1.7±1.3%, P = 0.005), and higher percentage reaching A1C target <7.0% (47.5 vs. 40.3%, P < 0.001). LM75/25 was associated with higher insulin dose (0.47±0.23 vs. 0.40±0.23 U/kg/day, P < 0.001) and more weight gain (3.6±4.0 vs. 2.5±4.0 kg, P < 0.0001). LM75/25 patients had a higher overall hypoglycemia rate than GL (28.0±41.6 vs. 23.1±40.7 episodes/pt/yr, P = 0.007), but lower nocturnal hypoglycemia rate (8.9±19.3 vs. 11.4±25.3 episodes/pt/yr, P = 0.009). Severe hypoglycemia rates were low in both groups (LM75/25: 0.10±1.6 episodes/pt/yr; GL: 0.03±0.3; P = 0.167).
Conclusions: Compared to GL, LM75/25 resulted in slightly lower A1C at 24 weeks and a moderately higher percentage reaching A1C target <7.0%. Patients receiving LM75/25 experienced more weight gain and higher rates of overall hypoglycemia, but lower rates of nocturnal hypoglycemia. Durability of regimens will be evaluated in the following 2-year maintenance phase.
Footnotes
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- Received November 26, 2008.
- Accepted March 18, 2009.
- Copyright © American Diabetes Association
