CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Amylin Pharmaceuticals, LLC..
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Amylin Pharmaceuticals, LLC.
Collaborator:
Eli Lilly and Company
Information provided by:
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00635492
First received: February 20, 2008
Last updated: April 12, 2010
Last verified: April 2010
| Tracking Information | |||||
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| First Received Date ICMJE | February 20, 2008 | ||||
| Last Updated Date | April 12, 2010 | ||||
| Start Date ICMJE | February 2008 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time. [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00635492 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy | ||||
| Official Title ICMJE | A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months. | ||||
| Brief Summary | Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimes are being modified in a timely manner and in response to which factors, what treatment changes are made, and clinical outcomes. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The study population will consist of patients aged 18 or above, with type 2 diabetes who, together with their physician, have decided to initiate either insulin, or exenatide for the first time for the treatment of type 2 diabetes. |
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| Condition ICMJE | Type 2 Diabetes Mellitus | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 5600 | ||||
| Estimated Completion Date | August 2011 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark, France, Germany, Greece, Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00635492 | ||||
| Other Study ID Numbers ICMJE | H8O-EW-B005 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | James Malone, MD, Study Director, Eli Lilly and Company | ||||
| Study Sponsor ICMJE | Amylin Pharmaceuticals, LLC. | ||||
| Collaborators ICMJE | Eli Lilly and Company | ||||
| Investigators ICMJE |
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| Information Provided By | Amylin Pharmaceuticals, LLC. | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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