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

NCT ID: NCT00635492

Last Updated: 2015-04-09

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2515 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

exenatide

exenatide

Intervention Type DRUG

subcutaneous injection, 5mcg or 10mcg, twice a day

2

insulin

any human insulin or analog insulin(s) given in any regimen by subcutaneous injection

Intervention Type DRUG

Interventions

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exenatide

subcutaneous injection, 5mcg or 10mcg, twice a day

Intervention Type DRUG

any human insulin or analog insulin(s) given in any regimen by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Byetta

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Malone, MD

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Research Site

Amager, , Denmark

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Rønne, , Denmark

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Toul, , France

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Alsfeld, , Germany

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Aschaffenburg, , Germany

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Augsburg, , Germany

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Aßlar, , Germany

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Bad Aibling, , Germany

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Bad Homburg, , Germany

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Bad Mergentheim, , Germany

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Bergheim, , Germany

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Berlin, , Germany

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Birkenfeld, , Germany

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Bosenheim, , Germany

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Bruchsal, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Duisburg, , Germany

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Eberswalde, , Germany

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Eilenburg, , Germany

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Eisenach, , Germany

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Erfurt, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Gebhardshain, , Germany

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Gersfeld, , Germany

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Giessen, , Germany

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Gifhorn, , Germany

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Grassau, , Germany

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Groß-Gerau, , Germany

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Hadmersleben, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hammelburg, , Germany

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Hennigsdorf, , Germany

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Hohenmölsen, , Germany

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Ismaning, , Germany

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Köthen, , Germany

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Kutenholz, , Germany

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Langen, , Germany

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Langenfeld, , Germany

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Leipzig, , Germany

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Lichtenfels, , Germany

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Ludwigsburg, , Germany

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Lüneburg, , Germany

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Marburg, , Germany

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Mayen, , Germany

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Meissen, , Germany

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Minden, , Germany

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Mönchengladbach, , Germany

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München, , Germany

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Münster, , Germany

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Nassau, , Germany

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Netphen, , Germany

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Oberhausen, , Germany

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Pirmasens, , Germany

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Recklinghausen, , Germany

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Rehburg-Loccum, , Germany

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Reichenbach, , Germany

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Riesa, , Germany

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Saarbrücken, , Germany

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Saarlouis, , Germany

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Schkeuditz, , Germany

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Schönwalde, , Germany

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Schweinfurt, , Germany

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Seligenstadt, , Germany

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Siegen, , Germany

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Stockach, , Germany

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Thale, , Germany

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Ueckermünde, , Germany

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Übach-Palenberg, , Germany

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Villingen-Schwenningen, , Germany

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Völklingen, , Germany

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Warburg, , Germany

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Weißenberg, , Germany

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Werl, , Germany

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Westfalica, , Germany

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Wilhelmshaven, , Germany

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Wurzen, , Germany

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Kozani, , Greece

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N. Efkarpia, , Greece

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Thessaloniki, , Greece

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Véroia, , Greece

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Angered, , Sweden

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Ängelholm, , Sweden

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Dalby, , Sweden

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Falun, , Sweden

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Gothenburg, , Sweden

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Limhamn, , Sweden

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Luleå, , Sweden

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Malmo, , Sweden

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Skivarp, , Sweden

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Skövde, , Sweden

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Stockholm, , Sweden

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Vadstena, , Sweden

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Västervik, , Sweden

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Countries

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Denmark France Germany Greece Sweden

References

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Schultheis 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.

Reference Type DERIVED
PMID: 33049248 (View on PubMed)

Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljanski J, Salaun-Martin C, Sapin H, Theodorakis M, Guerci B. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013 Dec 26;11:217. doi: 10.1186/1477-7525-11-217.

Reference Type DERIVED
PMID: 24369764 (View on PubMed)

Other Identifiers

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H8O-EW-B005

Identifier Type: -

Identifier Source: org_study_id

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