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Observational Study in Japanese Type 2 Diabetes Patients

NCT ID: NCT01055808

Last Updated: 2010-12-10

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

Total Enrollment

677 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-11-30

Brief Summary

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This study is designed to address the gap in the literature related to changing treatment regimen or formulation between different types of insulin, and how this change impacts quality of life, adherence, individual patient treatment satisfaction and glycemic control.

Detailed Description

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To measure changes in Health Related Quality of Life (as measured by the Insulin Therapy Related-Quality of Life: ITR-QOL) in insulin treated type 2 diabetes over a 12 weeks period following a significant change in insulin treatment regimen. Definition of significant change is a) increase or decrease the in number of injections per day, or/and b) change in formulation of insulin (human or analog insulin, basal or bolus, rapid or mix insulin), and/or c) change in administration method (syringe or pen, disposal or re-usable).

Conditions

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Diabetes Mellitus, Type 2

Keywords

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Insulin ITR-QOL DTSQ Diabetes Mellitus, Type 2

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Type 2 diabetes treated with insulin

Insulins

Intervention Type DRUG

Individual dose and frequency and duration as determined by the treating physician

Interventions

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Insulins

Individual dose and frequency and duration as determined by the treating physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Inpatients or outpatients with type 2 diabetes, aged 20 years or older, on insulin therapy who have planned to change insulin therapy during the registration period of the study
* Patients who have provided written informed consent to participation in the study after receiving explanations about the objective and other details of the study
* Patients who have received the same insulin therapy for 3 months or longer before informed consent. (i.e. receiving the same type of insulin preparation at the same dosing frequency regardless of insulin dose)

Exclusion Criteria

* Patients who have planned to discontinue insulin therapy
* Patients incapable of completing the ITR-QOL, DTSQ and patient's questionnaire based on their self-ratings
* Patients with type 1 diabetes
* Patients who have used CSII or have planned to switch to CSII(continuous subcutaneous insulin infusion )
* Patients with poor treatment compliance as determined by their investigators based on the treatment history
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri from 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hyōgo, , Japan

Site Status

Countries

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Japan

References

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Ishii H, Terauchi Y, Jinnouchi H, Taketsuna M, Takeuchi M, Imaoka T. Effects of insulin changes on quality of life and glycemic control in Japanese patients with type 2 diabetes mellitus: The insulin-changing study intending to gain patients' insights into insulin treatment with patient-reported health outcomes in actual clinical treatments (INSIGHTs) study. J Diabetes Investig. 2013 Nov 27;4(6):560-70. doi: 10.1111/jdi.12086. Epub 2013 Apr 30.

Reference Type DERIVED
PMID: 24843710 (View on PubMed)

Other Identifiers

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F3Z-JE-PV06

Identifier Type: OTHER

Identifier Source: secondary_id

13614

Identifier Type: -

Identifier Source: org_study_id