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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00635492
First received: February 20, 2008
Last updated: June 6, 2014
Last verified: June 2014
  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 regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: exenatide
Drug: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months. [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

    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.

    Initial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.

    Significant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:

    Insulin:

    • Addition of a new medication for the treatment of type 2 diabetes
    • A change in the number of times insulin is administered per day
    • Discontinuation of any insulin initiated at baseline
    • Substitution of a human insulin for an analogue insulin or vice-versa.
    • Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.

    Exenatide:

    • Addition of a new medication for the treatment of type 2 diabetes
    • Discontinuation of exenatide.


Secondary Outcome Measures:
  • Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

  • Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.

  • Older Age Associated With Treatment Choice at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

  • Disinhibited Eating Associated With Treatment Choice at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

  • Higher Random Glucose Associated With Treatment Choice at Baseline [ Time Frame: 6 months prior to Baseline ] [ Designated as safety issue: No ]
    Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

  • Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline [ Time Frame: 4 weeks prior to Baseline ] [ Designated as safety issue: No ]
    Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

  • Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

  • Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).

  • Changes in HbA1c From Baseline to Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    Changes in HbA1c From Baseline to Month 24

  • Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24. Only patients with baseline HbA1c >= 7.0 % were included in this analysis

  • Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24. Note: Only patients with baseline HbA1c >=6.5% were included in this analysis.

  • Changes in Weight From Baseline to Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    Changes in Weight From Baseline to Month 24

  • Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
    Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months

  • Incidence of Hypoglycemia Between Baseline and 24 Months [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
    Incidence of Hypoglycemia between Baseline and 24 Months

  • Reasons for Discontinuation of Baseline Regimen [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Reasons for Discontinuation of Baseline Regimen

  • Factors Associated With Treatment Change in Insulin Cohort [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort

  • Factors Associated With Treatment Change in Exenatide BID Cohort [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).

  • Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months

  • Number of Contacts With Health Care Providers Between Baseline and 24 Months [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Number of contacts with Health Care Providers Between Baseline and 24 Months

  • Percentage of Patients Hospitalized Between Baseline and 24 Months [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
    Percentage of Patients Hospitalized Between Baseline and 24 Months


Enrollment: 2515
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
exenatide
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
Other Name: Byetta
2
insulin
Drug: any human insulin or analog insulin(s) given in any regimen by 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 consisted of patients aged 18 or above, with type 2 diabetes starting any of the available initial injectable treatment options (any insulin, or exenatide BID) for the treatment of type 2 diabetes as part of routine clinical care.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635492

  Show 96 Study Locations
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00635492     History of Changes
Other Study ID Numbers: H8O-EW-B005
Study First Received: February 20, 2008
Results First Received: July 31, 2013
Last Updated: June 6, 2014
Health Authority: France: Ministry of Health
Germany: Ministry of Health
Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
diabetes
insulin
exenatide
Byetta
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Exenatide
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014