NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000003123

Registered date:01/02/2010

Phase II clinical trial of nasal GLP-1 in type 2 diabetes

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedtype 2 diabetes
Date of first enrollment2008/04/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)nasal GLP-1(recombinant) placebo

Outcome(s)

Primary Outcomeglycoalbumin 1,5-AG amount of meal
Secondary Outcomeplasma glucose insulin concentration glucagon concentration lipid profile body weight and body composition level of hunger appetite score

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria1. type 2 diabetes in accordance with WHO criteria who are treated with oral anti-diabetic agents 2. HbA1c 6.5~9.0% 3. age between 20 and 70 years old 4. out-clinic patient 5. informed consent
Exclude criteria1. type 1 diabetes 2. brittle diabetes 3. patients who need insulin therapy 4. problems in nasal cavity 5. bronchial asthma 6. preproliferative and proliferative diabetic retinopathy 7. chronic renal failure(serum CRE>3.0mg/dl) and who are treated with hemodialysis 8. acute myocardial infarction, unstable angina, acute coronary syndrome 9. obstruction of gastrointestinal tract 10. tube feeding or intravenous hyperalimentation 11. neoplasm 12. severe liver injury 13. chronic alcoholism or drug abuse 14. drug allergy 15. pregnant or in the lactation period 16. capability of pregnancy 17. history of other clinical trials within 2 months prior to the informed consent 18. patients whom the physician judges to be ineligible

Related Information

Contact

public contact
Name Masanari Mizuta
Address 5200 Kihara, Kiyotake, Miyazaki Japan
Telephone 0985-85-2965
E-mail mmizuta@fc.miyazaki-u.ac.jp
Affiliation University of Miyazaki Faculty of Medicine The 3rd Dept of Medicine
scientific contact
Name Masamitsu Nakazato
Address 5200 Kihara, Kiyotake, Miyazaki Japan
Telephone 0985-85-2965
E-mail
Affiliation University of Miyazaki Faculty of Medicine The 3rd Dept of Medicine