Observational Study in Japanese Type 2 Diabetes Patients

Diabetes Mellitus, Type 2 Clinical Trial

— INSIGHTS  

Official title:

A Prospective, Non-safety Observational Study in Japanese Type 2 Diabetes Patients(INSIGHTS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055808
• Other study ID #: 13614
• Secondary ID: F3Z-JE-PV06
• Status: Completed
• Phase: N/A
• First received: January 23, 2010
• Last updated: December 9, 2010
• Start date: January 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulins
Individual dose and frequency and duration as determined by the treating physician

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Summarize by occurrence the reason for insulin treatment change at study entry		Baseline	No
Secondary	Change in HbA1c at baseline and 12 weeks after a significant change in insulin treatment regimen		Baseline, 12 weeks	No
Secondary	Change in treatment adherence at baseline and 12 weeks after a significant change in insulin treatment regimen		Baseline, 12 weeks	No
Secondary	Change in DTSQ (Diabetes treatment satisfaction questionnaire) at baseline and 12 weeks after a significant change in insulin treatment regimen		Baseline, 12 weeks	No
Secondary	Total daily dose of insulin		Baseline, over 12 weeks	No
Secondary	Change in type of insulin product		Baseline, 12 weeks	No
Secondary	Change from baseline in use of concomitant oral hypoglycemic drugs		Baseline, 12 weeks	No