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Efficacy of liraglutide in non-insulin-dependent diabetic patients with GAD autoantibody -positive

Efficacy of liraglutide in non-insulin-dependent diabetic patients with GAD autoantibody -positive - GRAPE study (Group of liRAglutide Prevention and Evaluation Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010043
Enrollment
60
Registered
2013-02-18
Start date
2013-02-25
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

Diabetes

Interventions

Once-daily administration of liraglutide (morning or evening) Once-daily administration of insulin glargine (before breakfast)

Sponsors

University of Yamanashi, Faculty of Medicine Department of Internal Medicine III
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. HbA1c(NGSP): 6.5%<= and <9.0% 2. GAD antibody positive (>=1.5U/mL) and fasting s-CPR >=1.0ng/mL 3. Duration of diabetes: 6 months<= and <=10 years 4. Age: 20<= and <80 years old 5. Patients who can washout OADs (sulfonylurea, biguanide, alpha-glucosidase inhibitor, gulinide, pioglitazone, DPP-4 inhibitor) or insulin therapy more than 1-month (1-week in case of insulin) before the entry. 6. Patients without history of liraglutide, exenatide or lixisenatide treatment

Exclusion criteria

Exclusion criteria: 1. Ketosis 2. Pregnant, or intention of becoming pregnant 3. Patients who has serious complication or concurrent disease 4. Any other condition which the investigator feels would interfere with the participation.

Design outcomes

Primary

MeasureTime frame
Change in s-CPR after oral glucose tolerance test

Secondary

MeasureTime frame
1. Percentage of withdrawn patients whose HbA1c are over 9.4%(NGSP) at two consecutive times measurements and the term until withdrawal. 2. Change in blood glucose level after oral glucose tolerance test every 6-month. 3. Change in HbA1c 4. Change in fasting plasma glucose 5. Change in fasting s-CPR 6. Change in circadian variability of blood-glucose 7. Change in weight 8. Change in blood pressure. 9. Change in islet autoantibodies (GAD antibody, IA-2 antibody, Insulin antibody, ZnT8 antibody)

Countries

Japan

Contacts

Public ContactTetsuro Kobayashi

University of Yamanashi, Faculty of Medicine Department of Internal Medicine III

tetsurou@yamanashi.ac.jp055-273-1111

Outcome results

None listed

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