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
Sponsor:
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

February 20, 2008
April 12, 2010
February 2008
August 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00635492 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
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.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Type 2 Diabetes Mellitus
  • Drug: exenatide
    subcutaneous injection, 5mcg or 10mcg, twice a day
  • Drug: any human insulin or analog insulin
    subcutaneous injection
  • 1
    Intervention: Drug: exenatide
  • 2
    Intervention: Drug: any human insulin or analog insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5600
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   France,   Germany,   Greece,   Sweden
 
NCT00635492
H8O-EW-B005
No
James Malone, MD, Study Director, Eli Lilly and Company
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
Amylin Pharmaceuticals, LLC.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP