Clinical trial NCT01055808: Observational Study in Japanese Type 2 Diabetes Patients
Official title: A Prospective, Non-safety Observational Study in Japanese Type 2 Diabetes Patients(INSIGHTS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Insulin
ITR-QOL
DTSQ
Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 677
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese patients with type 2 diabetes who are treated with insulin and about to have significant treatment change.

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Summarize by occurrence the reason for insulin treatment change at study entry
timeFrame: Baseline
measure: Change in HbA1c at baseline and 12 weeks after a significant change in insulin treatment regimen
timeFrame: Baseline, 12 weeks
measure: Change in treatment adherence at baseline and 12 weeks after a significant change in insulin treatment regimen
timeFrame: Baseline, 12 weeks
measure: Change in DTSQ (Diabetes treatment satisfaction questionnaire) at baseline and 12 weeks after a significant change in insulin treatment regimen
timeFrame: Baseline, 12 weeks
measure: Total daily dose of insulin
timeFrame: Baseline, over 12 weeks
measure: Change in type of insulin product
timeFrame: Baseline, 12 weeks
measure: Change from baseline in use of concomitant oral hypoglycemic drugs
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Hyogo
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.