CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - Full Text View

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00635492

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:	Cohort, 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:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Exenatide

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, Inc.:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Contacts

Contact: Clinical Trials Support Center

1-877-CTLILLY (1-877-285-4559)

Show 96 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

James Malone, MD

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:	H8O-EW-B005
Study First Received:	February 20, 2008
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00635492 History of Changes
Health Authority:	France: Ministry of Health; Germany: Ministry of Health; Sweden: Medical Products Agency

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
insulin
exenatide

Byetta
Amylin
Lilly

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Amylin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 10, 2009