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

• Published in: Diabetes care Vol. 37; no. 7; pp. 2024 - 2027
• Main Authors: UENO, Hiroaki, MIZUTA, Masanari, SHIIYA, Tomomi, TSUCHIMOCHI, Wakaba, NOMA, Kenji, NAKASHIMA, Noboru, FUJIHARA, Mitsuteru, NAKAZATO, Masamitsu
• Format: Journal Article
• Language: English
• Published: Alexandria, VA American Diabetes Association 01.07.2014
• Subjects: Administration, Intranasal; Aged; Asian Continental Ancestry Group; Biological and medical sciences; Clinical trials; Diabetes; Diabetes Mellitus, Type 2 - drug therapy; Diabetes. Impaired glucose tolerance; Double-Blind Method; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Female; Glucagon - metabolism; Glucagon-Like Peptide 1 - administration & dosage; Glucagon-Like Peptide 1 - pharmacokinetics; Glucagon-Like Peptide 1 - therapeutic use; Humans; Insulin - metabolism; Insulin Secretion; Male; Medical sciences; Medical treatment; Metabolic diseases; Middle Aged; Peptides; Prospective Studies; Asia; Japan; Endocrinopathy; Type 2 diabetes; Human; Gastrointestinal hormone; Nutrition; Clinical trial; Patient; Metabolic diseases; Intranasal administration; Japanese; Endocrinology; Glucagon like peptide 1
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/dc13-0690

This study aimed to assess the efficacy and safety of our newly developed nasal glucagon-like peptide-1 (GLP-1) compound and injector. 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. 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. 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.