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NCT01855087 Clinical Trial

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

Type 2 Diabetes Clinical Trial

— ASSIST-K  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01855087
Other study ID # R875
Secondary ID
Status Completed
Phase N/A
First received May 10, 2013
Last updated May 13, 2013

Study information
Verified date May 2013
Source Kanagawa Physicians Association
Contact n/a
Is FDA regulated No
Health authority Japan: Ethical Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date March 2013
Accepts healthy volunteers
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Takai Naika Clinic Kamakura Kanagawa

Sponsors (2)
Lead Sponsor Collaborator
Kanagawa Physicians Association The Japan Kidney Foundation

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood glucose level Six months after starting sitagliptin-insulin combination therapy
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