Trials Sponsors Conditions Drugs Pricing

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetesinsulinexenatideByettaAmylinLilly

Outcome Measures

Primary Outcomes (1)

Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.
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.
Month 24

Secondary Outcomes (20)

Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline
Baseline
Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline
Baseline
Older Age Associated With Treatment Choice at Baseline
Baseline
Disinhibited Eating Associated With Treatment Choice at Baseline
Baseline
Higher Random Glucose Associated With Treatment Choice at Baseline
6 months prior to Baseline
+15 more secondary outcomes

Study Arms (2)

1

exenatide

Drug: exenatide

2

insulin

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

Interventions

exenatideDrug

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

Also known as: Byetta

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

are aged 18 or above

Sponsors & Collaborators

AstraZeneca
Industrylead
Eli Lilly and Company
Industrycollaborator

Study Sites (96)

Research Site

Amager, Denmark

Research Site

Rønne, Denmark

Research Site

Toul, France

Research Site

Alsfeld, Germany

Research

Aschaffenburg, Germany

Research Site

Augsburg, Germany

Research Site

Aßlar, Germany

Research Site

Related Publications (2)

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.
PMID: 33049248DERIVED
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.
PMID: 24369764DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin Resistance

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenoms

Limitations and Caveats

1. Serious adverse events (SAEs) and adverse events (AEs) were not collected as part of this observational study 2. Factors associated with treatment choice : this analysis was done on baseline lock( april 2009) where all others are from final lock.

Results Point of Contact

Title: Peter Ohman, Medical Science Director
Organization: AstraZeneca

Study Officials

James Malone, MD
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

2,515 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 20, 2008

First Posted

March 13, 2008

Study Start

January 2008

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (96)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (20)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (96)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations