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Clinical Trial Details

Trial ID: L6086
Source ID: NCT00099619
Associated Drug: Exenatide/Insulin Glargine
Title: Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: exenatide/insulin glargine|DRUG: insulin glargine/exenatide
Outcome Measures: Primary: Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period., Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine., Baseline, Week 16, Week 32 | Secondary: Change in patient-reported outcomes from Baseline to the end of each 16-week period, Change in patient-based outcomes (Hypoglycemic Fear Survey, patient-preference questionnaires \[Treatment Evaluation and Treatment Preference questionnaires), Diabetes Symptom Checklist-Revised, Diabetes Treatment Flexibility Scale, Psychological General Well-Being Index, and the EuroQol (EQ-5D) instrument\] from Baseline to the end of each 16-week exenatide or insulin glargine period, Baseline, Week 16, Week 32
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 138
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2004-09
Completion Date: 2005-08
Results First Posted:
Last Update Posted: 2015-02-23
Locations: Research Site, Westmead, New South Wales, Australia|Research Site, Daw Park, South Australia, Australia|Research Site, Fullarton, South Australia, Australia|Research Site, Box Hill, Victoria, Australia|Research Site, East Ringwood, Victoria, Australia|Research Site, Athens, Greece|Research Site, Piraeus, Greece|Research Site, Thessaloniki, Greece|Research Site, Budapest, Hungary|Research Site, Gyula, Hungary|Research Site, Pecs, Hungary|Research Site, Veszprem, Hungary|Research Site, Zalaegerszeg, Hungary|Research Site, Bari, Italy|Research Site, Bergamo, Italy|Research Site, Catania, Italy|Research Site, Milan, Italy|Research Site, Perugia, Italy|Research Site, Rome, Italy|Research Site, Guadalajara, Jalisco, Mexico|Research Site, Zapopan, Jalisco, Mexico|Research Site, Monterrey, N.l., Mexico|Research Site, Mexico City, Mexico|Research Site, Bydgoszcz, Poland|Research Site, Gdansk, Poland|Research Site, Lublin, Poland
URL: https://clinicaltrials.gov/show/NCT00099619

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress