Better Glycemic Control and Weight Loss With the Novel Long-Acting Basal Insulin LY2605541 Compared With Insulin Glargine in Type 1 Diabetes
A randomized, crossover study
- Julio Rosenstock, MD1,
- Richard M. Bergenstal, MD2,
- Thomas C. Blevins, MD3,
- Linda A. Morrow, MD4,
- Melvin J. Prince, MD5,
- Yongming Qu, PHD5,
- Vikram P. Sinha, PHD5,
- Daniel C. Howey, MD6 and
- Scott J. Jacober, DO5
- 1Dallas Diabetes and Endocrine Center at Medical City Dallas, Dallas, Texas
- 2International Diabetes Center at Park Nicollet, Minneapolis, Minnesota
- 3Texas Diabetes and Endocrinology, Austin, Texas
- 4Profil Institute for Clinical Research, Inc., Chula Vista, California
- 5Eli Lilly and Company, Indianapolis, Indiana
- 6Eli Lilly and Company retired, Indianapolis, Indiana
- Corresponding author: Scott J. Jacober, DO, .
OBJECTIVE To compare effects of LY2605541 versus insulin glargine on daily mean blood glucose as part of a basal-bolus regimen for type 1 diabetes.
RESEARCH DESIGN AND METHODS In this randomized, Phase 2, open-label, 2 × 2 crossover study, 137 patients received once-daily basal insulin (LY2605541 or glargine) plus mealtime insulin for 8 weeks, followed by crossover treatment for 8 weeks. Daily mean blood glucose was obtained from 8-point self-monitored blood glucose profiles. The noninferiority margin was 10.8 mg/dL.
RESULTS LY2605541 met noninferiority and superiority criteria compared with insulin glargine in daily mean blood glucose (144.2 vs. 151.7 mg/dL, least squares mean difference = −9.9 mg/dL [90% CI −14.6 to −5.2], P < 0.001). Fasting blood glucose variability and A1C were reduced with LY2605541 compared with insulin glargine (both P < 0.001). Mealtime insulin dose decreased with LY2605541 and increased with insulin glargine. Mean weight decreased 1.2 kg with LY2605541 and increased 0.7 kg with insulin glargine (P < 0.001). The total hypoglycemia rate was higher for LY2605541 (P = 0.04) and the nocturnal hypoglycemia rate was lower (P = 0.01), compared with insulin glargine. Adverse events (including severe hypoglycemia) were similar, although more gastrointestinal-related events occurred with LY2605541 (15% vs. 4%, P < 0.001). Mean changes (all within normal range) were higher for alanine aminotransferase, aspartate aminotransferase, triglycerides, and LDL-cholesterol and lower for HDL-cholesterol with LY2605541 compared with insulin glargine (all P < 0.02).
CONCLUSIONS In type 1 diabetes, compared with insulin glargine, LY2605541, a novel, long-acting basal insulin, demonstrated greater improvements in glycemic control, increased total hypoglycemia, and reduced nocturnal hypoglycemia, as well as reduced weight and lowered mealtime insulin doses.
- Received January 10, 2012.
- Accepted August 27, 2012.
- © 2012 by the American Diabetes Association.
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