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
  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
Sponsors 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 by Amylin Pharmaceuticals, LLC.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 16, 2014