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Completed

NCT Number: NCT01055808

Observational Study in Japanese Type 2 Diabetes Patients

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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, 651-0086, Japan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulins

Drug

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

Primary outcomes

  1. 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

    Time frame: Baseline, 12 weeks

Secondary outcomes

  1. Summarize by occurrence the reason for insulin treatment change at study entry

    Time frame: Baseline

  2. Change in HbA1c at baseline and 12 weeks after a significant change in insulin treatment regimen

    Time frame: Baseline, 12 weeks

  3. Change in treatment adherence at baseline and 12 weeks after a significant change in insulin treatment regimen

    Time frame: Baseline, 12 weeks

  4. Change in DTSQ (Diabetes treatment satisfaction questionnaire) at baseline and 12 weeks after a significant change in insulin treatment regimen

    Time frame: Baseline, 12 weeks

  5. Total daily dose of insulin

    Time frame: Baseline, over 12 weeks

  6. Change in type of insulin product

    Time frame: Baseline, 12 weeks

  7. Change from baseline in use of concomitant oral hypoglycemic drugs

    Time frame: Baseline, 12 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: INSIGHTS

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 26, 2010
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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