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Safety and Efficacy of Sitagliptin Added to Insulin Therapy for Type 2 Diabetes

A Study of Safety and Efficacy of Sitagliptin Added to Insulin Therapy in the Treatment of Type 2 Diabetes in Kanagawa

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01855087
Acronym
ASSIST-K
Enrollment
Unknown
Registered
2013-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2013-05-16

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

Conditions

Type 2 Diabetes

Brief summary

There is paucity of information about the combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin and insulin. This study aimed to retrospectively investigate the safety and efficacy of this therapeutic modality in Japanese patients with type 2 diabetes.

Interventions

None listed

Sponsors

The Japan Kidney Foundation
CollaboratorOTHER
Kanagawa Physicians Association
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

Inclusion criteria

* outpatients with type 2 diabetes * addition of sitagliptin to insulin therapy * aged 20 years or older * HbA1c of 6.9% or higher (NGSP) at the time of adding sitagliptin

Exclusion criteria

* history of hypersensitivity to sitagliptin * severe ketosis, diabetic coma, and/or precoma within 6 months before sitagliptin administration * sever infection and/or severe trauma, and/or patients who are scheduled to undergo / have recently underwent surgery * severe renal dysfunction (serum creatinine \[mg/dL\]: 2.5 or higher for men; 2.0 or higher for women) * ongoing treatment with glinide(s) * judgment as ineligible for the study by the attending physician

Design outcomes

Primary

MeasureTime frame
Blood glucose levelSix months after starting sitagliptin-insulin combination therapy

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026