Exploratory Trial of Intranasal Administration of Glucagon-like Peptide-1 in Japanese Patients With Type 2 Diabetes

  1. Masamitsu Nakazato1
  1. 1Division of Neurology, Respirology, Endocrinology, and Metabolism, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
  2. 2SPG Technology Co., Ltd, Miyazaki, Japan
  1. Corresponding author: Masamitsu Nakazato, nakazato{at}med.miyazaki-u.ac.jp.
  1. H.U. and M.M. contributed equally to this work.

Abstract

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.

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  1. Diabetes Care
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