Observational Study in Japanese Type 2 Diabetes Patients

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulins

• Registration Number: NCT01055808
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

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).

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-23
• Study First Submitted QC: 2010-01-23
• Study First Posted: 2010-01-26
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 677

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 diabetes treated with insulin	Insulins	-

Primary Outcome Measures

Name	Time	Method
Changes in Health Related Quality of Life (ITR-QOL) in insulin treated type 2 diabetes at baseline and 12 weeks after a significant change in insulin treatment regimen	Baseline, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Summarize by occurrence the reason for insulin treatment change at study entry	Baseline
Change in HbA1c at baseline and 12 weeks after a significant change in insulin treatment regimen	Baseline, 12 weeks
Change in treatment adherence at baseline and 12 weeks after a significant change in insulin treatment regimen	Baseline, 12 weeks
Change in DTSQ (Diabetes treatment satisfaction questionnaire) at baseline and 12 weeks after a significant change in insulin treatment regimen	Baseline, 12 weeks
Total daily dose of insulin	Baseline, over 12 weeks
Change in type of insulin product	Baseline, 12 weeks
Change from baseline in use of concomitant oral hypoglycemic drugs	Baseline, 12 weeks

Trial Locations

Locations (1)

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.; 🇯🇵 Hyogo, Japan