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Sitagliptin Trial For Safety And Efficacy In Elderly Patients With Moderately Controlled Type 2 Diabetes

Sitagliptin Trial For Safety And Efficacy In Elderly Patients With Moderately Controlled Type 2 Diabetes - Stream Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010376
Enrollment
200
Registered
2013-04-01
Start date
2012-04-25
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

Type 2 Diabetes

Interventions

Sitagliptin group Non-sitagliptin group (conventional treatment group)

Sponsors

STREAM research group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes meeting all of the following conditions: (1) Age :>=65 and <80 years old at the time of participation in the study (2)A NGSP HbA1c level :>=7.4% and <10.5% at the time of participation in the study (3) A stable HbA1c level (variation: within 1.0%) for 2 months before participation in the study (4) Patients with insufficient glucose control (meeting item (2) above) after treatment with dietary/exercise therapy or oral blood glucose-lowering agents (excluding glinide drugs which is not accepted of the combination) (5) Patients who give written consent

Exclusion criteria

Exclusion criteria: (1) Patients with type 1 diabetes (2) Patients under treatment with insulin (3) Patients under treatment with GLP-1 injection, a DPP4 inhibitor, or an investigational drug (4) Patients with severe renal dysfunction (eGFR: <30 mL/min), including those under treatment with dialysis (5) Patients judged to be ineligible by a physician

Design outcomes

Primary

MeasureTime frame
Changes in the HbA1c level and safety at 3, 6, and 12 months after study initiation

Secondary

MeasureTime frame
Blood glucose level at 3, 6, and 12 months after study initiation, Glycated albumin,Proinsulin/insulin ratio,Body weight, Course of diabetic complications, Hematology, Immunological test,

Countries

Japan

Contacts

Public ContactHitoshi Sugihara

Nippon Medical School Hospital Division of Endocrinology and Metabolism, Department of Medicine

hitoshi@nms.ac.jp03-3822-2131

Outcome results

None listed

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