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

NCT ID: NCT01855087

Last Updated: 2013-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Japan Kidney Foundation

OTHER

Sponsor Role collaborator

Kanagawa Physicians Association

OTHER

Sponsor Role lead

Responsible Party

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Ikuro Matsuba

Chairperson

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Takai Naika Clinic

Kamakura, Kanagawa, Japan

Site Status

Countries

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Japan

Other Identifiers

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R875

Identifier Type: -

Identifier Source: org_study_id

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