Primary outcomeNumber· Month 24
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
| Group | Value (probability (%)) | Spread |
|---|---|---|
| Exenatide BID | 53.9 | 123 |
| Insulin | 60.6 | 123 |
Trial · Observational
CompletedPhase not statedResults postedRegistry dataCHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
NCTNCT00635492 (opens ClinicalTrials.gov in a new tab)Other idH8O-EW-B005
Overview
- Status
- Completed
- Phase
- Phase not stated
- Enrollment
- 2,515 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Not stated
- Countries
5 countries
Denmark, France, Germany, Greece, Sweden
- Start
- Jan 2008
- Primary completion
- Dec 2011
- Completion
- Dec 2011
- First posted
- 13 Mar 2008 (estimated)
- Last update posted
- 9 Apr 2015 (estimated)
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20082009201020112012
- Ph –
CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
NCT00635492Jan 2008 to Dec 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- exenatideDrug
- any human insulin or analog insulin(s) given in any regimen by subcutaneous injectionDrug
Arms2
Other
1
exenatide
Other
2
insulin
Primary outcomes1
Outcomes the sponsor listed as primary.
Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
Time frame · Month 24
Registry description
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 outcomes(20)
Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Time frame · Baseline
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
Changes in HbA1c From Baseline to Month 24
Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24
Time frame · Month 24
Registry description
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
Registry description
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
Registry description
Changes in Weight From Baseline to Month 24
Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months
Time frame · Baseline to Month 24
Registry description
Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months
Incidence of Hypoglycemia Between Baseline and 24 Months
Time frame · Baseline to Month 24
Registry description
Incidence of Hypoglycemia between Baseline and 24 Months
Reasons for Discontinuation of Baseline Regimen
Time frame · Baseline to Month 24
Registry description
Reasons for Discontinuation of Baseline Regimen
Factors Associated With Treatment Change in Insulin Cohort
Time frame · Baseline to Month 24
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
Percentage of Patients Hospitalized Between Baseline and 24 Months
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline
Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
| Group | Value (kg/m^2) | Spread |
|---|---|---|
| Exenatide BID | 35.3 | 6.5 |
| Insulin | 29.7 | 5.4 |
Secondary outcomeMean· Baseline
Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline
| Group | Value (percent of hemoglobin) | Spread |
|---|---|---|
| Exenatide BID | 8.4 | 1.4 |
| Insulin | 9.2 | 1.9 |
Secondary outcomeMean· Baseline
Older Age Associated With Treatment Choice at Baseline
| Group | Value (years) | Spread |
|---|---|---|
| Exenatide BID | 58.1 | 10.1 |
| Insulin | 63.7 | 10.9 |
Secondary outcomeMean· Baseline
Disinhibited Eating Associated With Treatment Choice at Baseline
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Exenatide BID | 43.52 | 20.99 |
| Insulin | 34.38 | 20.33 |
Secondary outcomeMean· 6 months prior to Baseline
Higher Random Glucose Associated With Treatment Choice at Baseline
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide BID | 10.37 | 3.13 |
| Insulin | 12.13 | 4.36 |
Secondary outcomeMean· 4 weeks prior to Baseline
Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline
| Group | Value (tests/week) | Spread |
|---|---|---|
| Exenatide BID | 9.28 | 7.98 |
| Insulin | 9.91 | 8.58 |
Secondary outcomeNumber· Baseline
Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline
| Group | Value (participants) |
|---|---|
| Exenatide BID | 12 |
| Insulin | 1 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide BIDDaily dose ranging from 5-20 ug | – | 0 / 0 | 0 / 0 |
| InsulinInsulin at a dose selected by the HCP and patient | – | 0 / 0 | 0 / 0 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Observational study · 2013
7 results
Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study.
Reaney et al. 2013Health and quality of life outcomescited by 19
PMID 24369764PMC3900476DOI 10.1186/1477-7525-11-217PUB-24369764
CC BY7 results
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedSchultheis P, Montoya MN, Zhao Q, Archer J, Madden T, Peipert JF. Contraception and ectopic pregnancy risk: a prospective observational analysis. Am J Obstet Gynecol. 2021 Feb;224(2):228-229. doi: 10.1016/j.ajog.2020.10.013. Epub 2020 Oct 10. No abstract available. PMID 33049248
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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