Exenatide and Basal Insulins Use in the Real Setting: an Observational Study in Patients With Type 2 Diabetes
NCT ID: NCT01060059
Last Updated: 2015-04-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
888 participants
OBSERVATIONAL
2010-04-30
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Observational studies represent noninterventional research; therefore, this study does not involve randomization of patients to particular comparator arms or therapies. The term "noninterventional" means that the healthcare providers decisions regarding the proper treatment and care of the patient are made in the course of normal clinical practice. Patients enrolled in this study are enrolling for the collection of their data on observations made during normal clinical practice.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
NCT00359801
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
NCT00603239
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
NCT00308139
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
NCT00360334
Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes
NCT01140893
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
exenatide
The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.
exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
basal insulin
The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.
basal insulin
subcutaneous injection, dosing according to physician's clinical judgment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
basal insulin
subcutaneous injection, dosing according to physician's clinical judgment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Have presented during the routine course of care and, together with their physician, have decided to initiate treatment with either exenatide twice daily or conventional insulin therapy with basal insulin (insulin glargine, detemir, protaminated insulin lispro, protaminated human insulin) added to the existing treatment with OHA
3. Have not been treated with GLP-1 receptor agonist for more than 7 consecutive days within 3 months before entering the study
4. Have not been treated with insulins for more than 7 consecutive days within last 3 months or more than 3 months in the course of the disease
5. Are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
6. Have been fully informed and given their written consent for use of their data
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James Malone, MD
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research site
Acquaviva delle Fonti, , Italy
Research site
Anzio, , Italy
Research site
Bassano del Grappa, , Italy
Research site
Bologna, , Italy
Research site
Brindisi, , Italy
Research site
Cagliari, , Italy
Research site
Campi Salentina, , Italy
Research site
Casarano, , Italy
Research site
Caserta, , Italy
Research site
Cesena, , Italy
Research site
Chieri, , Italy
Research site
Cisternino, , Italy
Research site
Copertino, , Italy
Research site
Cremona, , Italy
Research site
Distretto Vittoria, , Italy
Research site
Fermo, , Italy
Research site
Ferrara, , Italy
Research site
Fidenza, , Italy
Research site
Florence, , Italy
Research site
Forlì, , Italy
Research site
Genova, , Italy
Research site
Germaneto, , Italy
Research site
Lecce, , Italy
Research site
Livorno, , Italy
Research site
Lucca, , Italy
Research site
Manfredonia (Le), , Italy
Research site
Mariano Comense, , Italy
Research site
Messina, , Italy
Research site
Milan, , Italy
Research site
Monza, , Italy
Research site
Napoli, , Italy
Research site
Novara, , Italy
Research site
Olbia, , Italy
Research site
Palermo, , Italy
Research site
Palmi, , Italy
Research site
Parma, , Italy
Research site
Pavia, , Italy
Research site
Pisa, , Italy
Research site
Potenza, , Italy
Research site
Rimini, , Italy
Research site
Roma, , Italy
Research site
Rossano Scalo, , Italy
Research site
Salerno, , Italy
Research site
San Giovanni Rotondo, , Italy
Research site
Schio, , Italy
Research site
Sesto San Giovanni, , Italy
Research site
Siena, , Italy
Research site
Treviso, , Italy
Research site
Trieste, , Italy
Research site
Varese, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H8O-IT-B014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.