Safety and Efficacy of Sitagliptin Added to Insulin Therapy for Type 2 Diabetes (ASSIST-K)

May 13, 2013 updated by: Ikuro Matsuba, Kanagawa Physicians Association

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-0056
        • Takai Naika Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

One-thousand Japanese patients with type 2 diabetes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood glucose level
Time Frame: Six months after starting sitagliptin-insulin combination therapy
Six months after starting sitagliptin-insulin combination therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanagawa Physicians Association

Collaborators

The Japan Kidney Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 16, 2013

Study Record Updates

Last Update Posted (Estimate)

May 16, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R875

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe