Study of Sitagliptin Treatment for Glycemic Control and Prevention of GAD-Ab Positive Non-insulin Dependent Diabetes Mellitus in Osaka

Study of Sitagliptin Treatment for Glycemic Control and Prevention of GAD-Ab Positive Non-insulin Dependent Diabetes Mellitus in Osaka - STGP-OSAKA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007926

Enrollment

Registered

2012-05-11

Start date

2012-04-01

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

GAD-Ab positive non-insulin dependent diabetes mellitus

Interventions

Sitagliptin group Sitagliptine begin with 50 mg once daily (max dose 100mg). Addition of metformin and/or alpha-GI are possible after increasing the dose of sitagliptine to 100mg. Control group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who met the criteria for diabetes mellitus. 1. Duration of diabetes should be within 5 yr from onset (or diagnosis). 2. GADAb positive: 1.5U/ml or higher 3. fasting serum C-peptide: 0.5ng/ml or higher 4. HbA1c(NGSP): <8.4% FPG: <160mg/dl

Exclusion criteria

Exclusion criteria: 1. Injection of insulin within 3 month before entry point 2. Pregnant or planning to be pregnant 3. Diabetic nephropathy: Class 3 or higher 4. Diabetic retinopathy: Preproliferative or higher 5. NYHA 3-4 6. History in use of DPP-4 inhibitor or GLP-1 analogue. 7. Physician's judgment.

Design outcomes

Primary

Measure	Time frame
Change of patients indicated an insulin-dependent state during 3 years. Rate of patients indicated an insulin-dependent state.	—

Secondary

Measure	Time frame
Change of HbA1c value. Change of Fasted plasma glucose, Fasted serum CPR value. Glucose level, glucagon level and C-peptide values during the liquid mixed-meal test. Average amount of insulin per a day. Rate of hypoglycemia. etc	—

Countries

Japan

Contacts

Public ContactJun-ichiro Miyagawa

Hyogo college of medicine Division of Diabetes and Metabolism, Department of Internal Medicine

0798-45-6111

Outcome results

None listed

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