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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-JE-PV06 | Other Identifier | Eli Lilly and Company |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetes treated with insulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulins | Drug | Individual dose and frequency and duration as determined by the treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Japanese patients with type 2 diabetes who are treated with insulin and about to have significant treatment change.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24843710 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061385 | Insulins |
| ID | Term |
|---|---|
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| 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 |
| Change in type of insulin product | Baseline, 12 weeks |
| Change from baseline in use of concomitant oral hypoglycemic drugs | Baseline, 12 weeks |
| Japan |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |