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Exploratory study of DPP-4 inhibitor on glycemic control and organ protection in type2 diabetic patients

Exploratory study of DPP-4 inhibitor on glycemic control and organ protection in type2 diabetic patients - Exploratory study of DPP-4 inhibitor on glycemic control and organ protection in type2 diabetic patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012171
Enrollment
60
Registered
2013-10-30
Start date
2013-10-30
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 diabetic patients (Type-2 diabetic patients with microalbuminuria or nephropathy)

Interventions

Sponsors

Tokyo Jikei University School of Medicine Kashiwa Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Type-2 diabetic patients who meet following criteria: 1)Type-2 diabetes millitus(HbA1c:6.5-8.5%) 2)Urinary albumin creatinin ratio(UACR):30-300mg/gCr 3)Age:30-74(Male and female) 4)Written informed consent are taken for the enrollement

Exclusion criteria

Exclusion criteria: 1)Type-1 diabetes millius 2)Serum creatinin level of more than 1.2mg/dL in male patients and 1.0mg/dL in female patients 3)Diabetic ketosis, diabetic coma or total coma within 6 months 4)Severe infectious disease, before or after surgery, and severe trauma 5)Occurrence of ischemic stroke, hemorrhagic stroke or TIA within 6 months 6)Moderate or severe heart failure (NYHE 3 or 4) 7)Patients who receive other DPP4 inhibitors during 3 month before starting study 8)Under treatment with insulin 9)Pregnant, lactating, possibly pregnant or planning to become pregnant women 10)Past medical history of hypersensitivity to linagliptin 11)Patients considered as inadequate by the principal investigator

Design outcomes

Primary

MeasureTime frame
1)The change of HbA1c at baseline and 24 week after DPP-4 inhibitor treatment. 2)The change of UACR, L-FABP and plasma BNP at baseline and 24 week after DPP-4 inhibitor treatment. 3)The co-relationship between HbA1c reduction and the change of UACR, L-FABP and plasma BNP.

Secondary

MeasureTime frame
1)Echocardiography, CAVI 2)Fasting plasma glucose, plasma inflammatory markers 3)Body weight,Blood pressure,plasma lipid 4)Safety

Countries

Japan

Contacts

Public ContactMaya Kano

Tokyo Jikei University School of Medicine Kashiwa Hospital Department of Internal Medicine, Division of Diabetes, Metabolism and Endocrinology

mayakichi@jikei.ac.jp0471-64-1111

Outcome results

None listed

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