| Trial ID: | L5733 |
| Source ID: | NCT00935532
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| Associated Drug: |
Exenatide Once Weekly
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| Title: |
Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
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| Acronym: |
|
| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00935532/results
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| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: exenatide once weekly|DRUG: insulin glargine
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| Outcome Measures: |
Primary: Change in HbA1c From Baseline to Endpoint (Week 26), Change in HbA1c from baseline to endpoint (Week 26)., Baseline, Week 26 | Secondary: Percentage of Subjects Achieving HbA1c<=7%, Percentage of subjects achieving HbA1c \<=7.0% (for subjects with HbA1c \>7% at baseline), Baseline, Week 26|Percentage of Subjects Achieving HbA1c<=6.5%, Percentage of subjects achieving HbA1c \<=6.5% (for subjects with HbA1c \>6.5% at baseline), Baseline, Week 26|Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26), Change in FSG (centralized measurement) from baseline to endpoint (Week 26), Baseline, Week 26|Change in Body Weight From Baseline to Endpoint (Week 26), Change in Body Weight from baseline to endpoint (Week 26), Baseline, Week 26|Change in Total Cholesterol From Baseline to Endpoint (Week 26), Change in Total Cholesterol from baseline to endpoint (Week 26), Baseline, Week 26|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26), Change in HDL-C from baseline to endpoint (Week 26), Baseline, Week 26|Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline, Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline., Baseline, Week 26|Change in Blood Pressure From Baseline to Endpoint (Week 26), Change in Blood Pressure from baseline to endpoint (Week 26), Baseline, Week 26|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events, Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS., Baseline to Week 26|Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events, Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS., Baseline to Week 26
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| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Eli Lilly and Company
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
427
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2009-07
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| Completion Date: |
2011-07
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| Results First Posted: |
2012-10-24
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| Last Update Posted: |
2015-06-15
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| Locations: |
Research Site, Aomori, Japan|Research Site, Chiba, Japan|Research Site, Ehime, Japan|Research Site, Fukuoka, Japan|Research Site, Gunma, Japan|Research Site, Hiroshima, Japan|Research Site, Hokkaido, Japan|Research Site, Hyogo, Japan|Research Site, Ibaragi, Japan|Research Site, Kagawa, Japan|Research Site, Kanagawa, Japan|Research Site, Kumamoto, Japan|Research Site, Kyoto, Japan|Research Site, Nagano, Japan|Research Site, Nagasaki, Japan|Research Site, Nara, Japan|Research Site, Oita, Japan|Research Site, Osaka, Japan|Research Site, Saitama, Japan|Research Site, Shizuoka, Japan|Research Site, Tokyo, Japan|Research Site, Toyama, Japan
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| URL: |
https://clinicaltrials.gov/show/NCT00935532
|
