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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus |
Drug: exenatide Drug: any human insulin or analog insulin |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Describe the characteristics of patients initiating each treatment (insulin or exenatide) and factors associated with treatment choice. Describe the discontinuation of oral medications following initiation of treatment with exenatide or insulin. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Describe and compare the clinical outcomes (including change in HbA1c from baseline, % of patients achieving specific glycaemic targets, change in weight); the incidence and severity of commonly reported side-effects of these medications. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Describe the reasons for discontinuation of insulin or exenatide. Determine which patient characteristics and other factors are associated with treatment change and describe any differences between cohorts. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Describe and compare the health related quality of life and patient reported outcomes of patients in each cohort. Describe and compare the resource use associated with treatment for diabetes of patients in each cohort. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 5600 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 1 |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
|
| 2 |
Drug: any human insulin or analog insulin
subcutaneous injection
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
Inclusion Criteria:
- are aged 18 or above
- diagnosed with type 2 diabetes
- have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes
- have not previously been treated with either insulin or exenatide
- are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
- have been fully informed and given their written consent for use of their data
- have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635492
Show 96 Study Locations
Show 96 Study LocationsSponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
| Study Director: | James Malone, MD | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| Responsible Party: | James Malone, MD, Study Director, Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00635492 History of Changes |
| Other Study ID Numbers: | H8O-EW-B005 |
| Study First Received: | February 20, 2008 |
| Last Updated: | April 12, 2010 |
| Health Authority: | France: Ministry of Health Germany: Ministry of Health Sweden: Medical Products Agency |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
diabetes insulin exenatide |
Byetta Amylin Lilly |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Exenatide Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013