Exploratory Trial of Intranasal Administration of Glucagon-like Peptide-1 in Japanese Patients With Type 2 Diabetes
- Hiroaki Ueno1,
- Masanari Mizuta1,
- Tomomi Shiiya1,
- Wakaba Tsuchimochi1,
- Kenji Noma1,
- Noboru Nakashima2,
- Mitsuteru Fujihara2 and
- Masamitsu Nakazato1⇑
- 1Division of Neurology, Respirology, Endocrinology, and Metabolism, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
- 2SPG Technology Co., Ltd, Miyazaki, Japan
- Corresponding author: Masamitsu Nakazato, .
H.U. and M.M. contributed equally to this work.
OBJECTIVE This study aimed to assess the efficacy and safety of our newly developed nasal glucagon-like peptide-1 (GLP-1) compound and injector.
RESEARCH DESIGN AND METHODS Twenty-six patients with type 2 diabetes were enrolled in this double-blind placebo-controlled study. The nasal compound containing 1.2 mg of human GLP-1 (7–36) amide or placebo was administered immediately before every meal for 2 weeks.
RESULTS The plasma peak concentration of active GLP-1 was 47.2 pmol/L, and its Tmax was 8.1 min. The early phase of insulin and glucagon secretion were recovered and suppressed, respectively, in the GLP-1 group. Glycoalbumin levels became significantly lower and 1,5-anhydroglucitol levels significantly higher after GLP-1 administration. No marked adverse events were observed after using nasal GLP-1.
CONCLUSIONS The newly developed nasal GLP-1 compound may be a potential treatment for type 2 diabetes. The long-term application of the drug should be evaluated in future trials.
- Received March 22, 2013.
- Accepted November 1, 2013.
- © 2014 by the American Diabetes Association.
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