Observational Study in Japanese Type 2 Diabetes Patients (INSIGHTS)

Lilly

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulins

Study type: Observational

Funder types: Industry

Identifiers

NCT01055808

F3Z-JE-PV06 (Other Identifier)

13614

Details and patient eligibility

About

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.

Full 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).

Enrollment: 677 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

677 participants in 1 patient group

Type 2 diabetes treated with insulin

Treatment:

Drug: Insulins