Observational Study in Japanese Type 2 Diabetes Patients (INSIGHTS)
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01055808
First received: January 23, 2010
Last updated: December 9, 2010
Last verified: December 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Insulins |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | A Prospective, Non-safety Observational Study in Japanese Type 2 Diabetes Patients(INSIGHTS) |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Summarize by occurrence the reason for insulin treatment change at study entry [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Change in HbA1c at baseline and 12 weeks after a significant change in insulin treatment regimen [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
- Change in treatment adherence at baseline and 12 weeks after a significant change in insulin treatment regimen [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Total daily dose of insulin [ Time Frame: Baseline, over 12 weeks ] [ Designated as safety issue: No ]
- Change in type of insulin product [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in use of concomitant oral hypoglycemic drugs [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 677 |
| Study Start Date: | January 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Type 2 diabetes treated with insulin |
Drug: Insulins
Individual dose and frequency and duration as determined by the treating physician
|
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| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Japanese patients with type 2 diabetes who are treated with insulin and about to have significant treatment change.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055808
Locations
| Japan | |
| 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. | |
| Hyogo, Japan, 651-0086 | |
Sponsors and Collaborators
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 |
More Information
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT01055808 History of Changes |
| Other Study ID Numbers: | 13614, F3Z-JE-PV06 |
| Study First Received: | January 23, 2010 |
| Last Updated: | December 9, 2010 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Eli Lilly and Company:
|
Insulin ITR-QOL DTSQ Diabetes Mellitus, Type 2 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013