Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study.

Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljański J, Salaun-Martin C, Sapin H, Theodorakis M, Guerci B

Health and quality of life outcomes26 Dec 2013Cited by 19 (Europe PMC)

PMID24369764PMCIDPMC3900476DOI10.1186/1477-7525-11-217PepBankPUB-24369764

Summary

BackgroundImprovements in the clinical condition of patients with type 2 diabetes are often accompanied by improvements in health-related quality of life and other patient-reported outcomes (PROs), but data assessing injectable treatment initiation from the patient's perspective in routine clinical practice are lacking. We examined PROs in patients initiating injectable treatment in the CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy) study.MethodsCHOICE was a 24-month, prospective observational study conducted in six European countries. Patients initiated exenatide twice daily (BID) or insulin based on a physician's clinical judgement. Clinical and PRO data were collected at baseline (injectable therapy initiation) and after approximately 3, 6, 12, 18 and 24 months. The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted.ResultsThere were 2388 patients eligible for analysis (exenatide BID cohort, n = 1114; insulin cohort, n = 1274). Mean positive changes in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score and EuroQoL5-Dimension (EQ-5D) index and visual analogue scale (VAS) scores were observed in both cohorts with most changes observed during the first 6 months after injectable therapy initiation. Patients who experienced weight loss (≥ 1 kg) at 24 months appeared to have higher mean improvements in IWQOL-Lite total score than did patients with weight gain or no weight change. Patients who met the composite clinical endpoint of glycated haemoglobin (HbA1c) <7.0%, no weight gain (≤ 1 kg) and no hypoglycaemia generally experienced higher mean improvements in EQ-5D index and VAS scores (compared with patients who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts). High levels of missing data were observed for all PRO measures in both cohorts compared with those for clinical outcomes.ConclusionsThese data from a clinical practice study support those from clinical trials, suggesting that PROs are not adversely affected, and may be improved, by injectable therapy initiation. PRO data may aid appropriate treatment selection for individual patients.Trial registrationClinicalTrials.gov, NCT00635492.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone7

In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Exenatide (exendin-4).

01HumanNot a test of Exenatide (exendin-4) aloneObservational studyEfficacy outcome
In patients with type 2 diabetes, IWQOL-Lite scores improved after exenatide initiation, as in the insulin cohort.
In plain wordsIn patients with diabetes, exenatide initiation was linked to improved weight-related quality of life, as was insulin initiation.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseIWQOL-Lite total score
Study
n: not reported in source
Outcome group
Quality of life · Whole body
Source sentences
Summary
Mean positive changes in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score and EuroQoL5-Dimension (EQ-5D) index and visual analogue scale (VAS) scores were observed in both cohorts with most changes observed during the first 6 months after injectable therapy initiation.
3 context sentences(design, population, supporting numbers)
Summary · context
CHOICE was a 24-month, prospective observational study conducted in six European countries.
Summary · context
Patients initiated exenatide twice daily (BID) or insulin based on a physician's clinical judgement.
Summary · context
The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2436976401
02HumanNot a test of Exenatide (exendin-4) aloneObservational studyEfficacy outcome
In patients with type 2 diabetes, EQ-5D index scores improved after exenatide initiation, as in the insulin cohort.
In plain wordsIn patients with diabetes, exenatide initiation was linked to improved EQ-5D index scores, as was insulin initiation.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseEQ-5D index
Study
n: not reported in source
Outcome group
Quality of life · Whole body
Source sentences
Summary
Mean positive changes in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score and EuroQoL5-Dimension (EQ-5D) index and visual analogue scale (VAS) scores were observed in both cohorts with most changes observed during the first 6 months after injectable therapy initiation.
3 context sentences(design, population, supporting numbers)
Summary · context
CHOICE was a 24-month, prospective observational study conducted in six European countries.
Summary · context
Patients initiated exenatide twice daily (BID) or insulin based on a physician's clinical judgement.
Summary · context
The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2436976402
03HumanNot a test of Exenatide (exendin-4) aloneObservational studyEfficacy outcome
In patients with type 2 diabetes, EQ-5D VAS scores improved after exenatide initiation, as in the insulin cohort.
In plain wordsIn patients with diabetes, exenatide initiation was linked to improved health ratings, as was insulin initiation.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseEQ-5D VAS score
Study
n: not reported in source
Outcome group
Quality of life · Whole body
Source sentences
Summary
Mean positive changes in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total score and EuroQoL5-Dimension (EQ-5D) index and visual analogue scale (VAS) scores were observed in both cohorts with most changes observed during the first 6 months after injectable therapy initiation.
3 context sentences(design, population, supporting numbers)
Summary · context
CHOICE was a 24-month, prospective observational study conducted in six European countries.
Summary · context
Patients initiated exenatide twice daily (BID) or insulin based on a physician's clinical judgement.
Summary · context
The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2436976403
04HumanNot a test of Exenatide (exendin-4) aloneObservational studyOther
Across injectable-treatment cohorts, weight loss was linked to apparently greater IWQOL-Lite improvement than weight gain or no change.
In plain wordsAcross treatment cohorts, patients with weight loss appeared to have greater quality-of-life improvements than those with weight gain or no change.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseWeight loss and IWQOL-Lite improvement
Study
n: not reported in source
Comparator
Weight gain or no weight change
Outcome group
Quality of life · Whole body
Source sentences
Summary
Patients who experienced weight loss (≥ 1 kg) at 24 months appeared to have higher mean improvements in IWQOL-Lite total score than did patients with weight gain or no weight change.
3 context sentences(design, population, supporting numbers)
Summary · context
CHOICE was a 24-month, prospective observational study conducted in six European countries.
Summary · context
Patients initiated exenatide twice daily (BID) or insulin based on a physician's clinical judgement.
Summary · context
The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2436976404
05HumanNot a test of Exenatide (exendin-4) aloneObservational studyOther
Across injectable-treatment cohorts, patients meeting the composite clinical endpoint generally had greater EQ-5D index improvements than non-achievers.
In plain wordsAcross treatment cohorts, patients meeting the combined clinical target generally had greater EQ-5D index improvements than those who did not.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseComposite endpoint and EQ-5D index improvement
Study
n: not reported in source
Comparator
Patients who did not meet the composite endpoint
Outcome group
Quality of life · Whole body
Source sentences
Summary
Patients who met the composite clinical endpoint of glycated haemoglobin (HbA1c) <7.0%, no weight gain (≤ 1 kg) and no hypoglycaemia generally experienced higher mean improvements in EQ-5D index and VAS scores (compared with patients who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts).
3 context sentences(design, population, supporting numbers)
Summary · context
CHOICE was a 24-month, prospective observational study conducted in six European countries.
Summary · context
Patients initiated exenatide twice daily (BID) or insulin based on a physician's clinical judgement.
Summary · context
The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2436976405
06HumanNot a test of Exenatide (exendin-4) aloneObservational studyOther
Across injectable-treatment cohorts, patients meeting the composite clinical endpoint generally had greater VAS improvements than non-achievers.
In plain wordsAcross treatment cohorts, patients meeting the combined clinical target generally had greater health-rating improvements than those who did not.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseComposite endpoint and VAS improvement
Study
n: not reported in source
Comparator
Patients who did not meet the composite endpoint
Outcome group
Quality of life · Whole body
Source sentences
Summary
Patients who met the composite clinical endpoint of glycated haemoglobin (HbA1c) <7.0%, no weight gain (≤ 1 kg) and no hypoglycaemia generally experienced higher mean improvements in EQ-5D index and VAS scores (compared with patients who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts).
3 context sentences(design, population, supporting numbers)
Summary · context
CHOICE was a 24-month, prospective observational study conducted in six European countries.
Summary · context
Patients initiated exenatide twice daily (BID) or insulin based on a physician's clinical judgement.
Summary · context
The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2436976406
07HumanNot a test of Exenatide (exendin-4) aloneObservational studyOther
Across injectable-treatment cohorts, composite-endpoint achievers generally had greater Diabetes Health Profile-18 improvements than the main cohorts.
In plain wordsAcross treatment cohorts, patients meeting the combined clinical target generally had greater diabetes health-profile improvements than the main cohorts.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseComposite endpoint and Diabetes Health Profile-18 improvement
Study
n: not reported in source
Comparator
Main cohorts
Outcome group
Quality of life · Whole body
Source sentences
Summary
Patients who met the composite clinical endpoint of glycated haemoglobin (HbA1c) <7.0%, no weight gain (≤ 1 kg) and no hypoglycaemia generally experienced higher mean improvements in EQ-5D index and VAS scores (compared with patients who did not meet this endpoint) and Diabetes Health Profile-18 scores (versus the main cohorts).
3 context sentences(design, population, supporting numbers)
Summary · context
CHOICE was a 24-month, prospective observational study conducted in six European countries.
Summary · context
Patients initiated exenatide twice daily (BID) or insulin based on a physician's clinical judgement.
Summary · context
The two treatment cohorts had different baseline characteristics; therefore, no statistical comparisons of endpoints between main cohorts were conducted.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2436976407

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase not statedResults postedNCT00635492

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

AstraZenecan = 2,515Jan 2008 to Dec 2011

Type 2 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 9 Apr 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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