Diabetes Mellitus, Type 2INSIGHTSNCT01055808
Observational Study in Japanese Type 2 Diabetes Patients
An observational study of Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulins
- How many people
- 677 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2010to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Japanese patients with type 2 diabetes who are treated with insulin and about to have significant treatment change.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Japan1 site
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
About this study
Official title: 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.
Read the 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).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulins
- Keywords
- Insulin, ITR-QOL, DTSQ, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinsDrug
Individual dose and frequency and duration as determined by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes treated with insulin | Not described Receives: Drug: Insulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 12 weeks
Secondary outcomes (7)
Summarize by occurrence the reason for insulin treatment change at study entry
Measured: Baseline
Change in HbA1c at baseline and 12 weeks after a significant change in insulin treatment regimen
Measured: Baseline, 12 weeks
Change in treatment adherence at baseline and 12 weeks after a significant change in insulin treatment regimen
Measured: Baseline, 12 weeks
Change in DTSQ (Diabetes treatment satisfaction questionnaire) at baseline and 12 weeks after a significant change in insulin treatment regimen
Measured: Baseline, 12 weeks
Total daily dose of insulin
Measured: Baseline, over 12 weeks
Change in type of insulin product
Measured: Baseline, 12 weeks
Change from baseline in use of concomitant oral hypoglycemic drugs
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055808
- Sponsor's protocol ID
- 13614
- Other IDs
- F3Z-JE-PV06
- Acronym
- INSIGHTS
- Status last verified
- Dec 2010
- First submitted
- 23 Jan 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24843710
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-safety Observational Study in Japanese Type 2 Diabetes Patients(INSIGHTS)
- ClinicalTrials.gov ID
- NCT01055808
- Acronym / sponsor ID
- INSIGHTS / 13614
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Insulin, ITR-QOL, DTSQ, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes treated with insulin | – | Drug: Insulins |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Japanese patients with type 2 diabetes who are treated with insulin and about to have significant treatment change.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinsIndividual dose and frequency and duration as determined by the treating physician | Drug | Type 2 diabetes treated with insulin |
Primary outcome
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
7 secondary outcomes
Summarize by occurrence the reason for insulin treatment change at study entry
Time frame: Baseline
Change in HbA1c at baseline and 12 weeks after a significant change in insulin treatment regimen
Time frame: Baseline, 12 weeks
Change in treatment adherence at baseline and 12 weeks after a significant change in insulin treatment regimen
Time frame: Baseline, 12 weeks
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
Total daily dose of insulin
Time frame: Baseline, over 12 weeks
Change in type of insulin product
Time frame: Baseline, 12 weeks
Change from baseline in use of concomitant oral hypoglycemic drugs
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
- Derived from this study: PubMed 24843710Ishii 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01055808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2010.