Observational Study in Japanese Type 2 Diabetes Patients (INSIGHTS)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulins

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 Type: Observational
• Enrollment (Actual): 677

Contacts and Locations

Study Locations

• Japan
  • Hyogo, Japan, 651-0086
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Japanese patients with type 2 diabetes who are treated with insulin and about to have significant treatment change.

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type 2 diabetes treated with insulin	Drug: Insulins; Individual dose and frequency and duration as determined by the treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: January 23, 2010
• First Submitted That Met QC Criteria: January 23, 2010
• First Posted (Estimate): January 26, 2010

Study Record Updates

• Last Update Posted (Estimate): December 10, 2010
• Last Update Submitted That Met QC Criteria: December 9, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Insulin; Diabetes Mellitus, Type 2; ITR-QOL; DTSQ
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 13614; F3Z-JE-PV06 (Other Identifier: Eli Lilly and Company)