NCT01055808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
677

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

10 months

First QC Date

January 23, 2010

Last Update Submit

December 9, 2010

Conditions

Diabetes Mellitus, Type 2

Keywords

InsulinITR-QOLDTSQDiabetes Mellitus, Type 2

Outcome Measures

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

    Baseline, 12 weeks

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Type 2 diabetes treated with insulin

Drug: Insulins

Interventions

InsulinsDRUG

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

Type 2 diabetes treated with insulin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

Related Publications (1)

  • 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.

    PMID: 24843710DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Insulins

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Pancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 23, 2010

First Posted

January 26, 2010

Study Start

January 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 10, 2010

Record last verified: 2010-12

Locations

JP(1)