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

UMIN ID: UMIN000003123

Registered date:01/02/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 2008/04/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

nasal GLP-1(recombinant)
placebo

Outcome(s)

• Primary Outcome: glycoalbumin 1,5-AG amount of meal
• Secondary Outcome: plasma glucose insulin concentration glucagon concentration lipid profile body weight and body composition level of hunger appetite score

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1. 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

• Primary Sponsor: University of Miyazaki Faculty of Medicine
• Source(s) of Monetary Support: Japan Science and Technology Agency (JST)