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

Phase II clinical trial of nasal GLP-1 in type 2 diabetes - JNAS71

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003123
Enrollment
30
Registered
2010-02-01
Start date
2008-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

nasal GLP-1(recombinant) placebo

Sponsors

University of Miyazaki Faculty of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
glycoalbumin 1,5-AG amount of meal

Secondary

MeasureTime frame
plasma glucose insulin concentration glucagon concentration lipid profile body weight and body composition level of hunger appetite score

Countries

Japan

Contacts

Public ContactMasanari Mizuta

University of Miyazaki Faculty of Medicine The 3rd Dept of Medicine

mmizuta@fc.miyazaki-u.ac.jp0985-85-2965

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026