| Trial ID: | L3365 |
| Source ID: | NCT00308139
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| Associated Drug: |
Exenatide, Long Acting Release
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| Title: |
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT00308139/results
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| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: exenatide, long acting release|DRUG: exenatide
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| Outcome Measures: |
Primary: Change in HbA1c From Baseline to Week 30, Absolute change in HbA1c from Baseline (Day -3) to Week 30 \[Week 30 - Baseline\], Day -3, Week 30|Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose), Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval, Week 22 | Secondary: Change in HbA1c From Baseline to Week 364, Absolute change in HbA1c from Baseline (Day -3) to Week 364, Day -3, Week 364|Percentage of Subjects Achieving HbA1c Target of <7%, Percentage of subjects achieving HbA1c target value of \<7% at Week 30., Week 30|Percentage of Subjects Achieving HbA1c Target of <7%, Percentages of subjects achieving HbA1c target value of \<7% at Week 364, Week 364|Percentage of Subjects Achieving HbA1c Target of <=6.5%, Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 30., Week 30|Percentage of Subjects Achieving HbA1c Target of <=6.5%, Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 364, Week 364|Percentage of Subjects Achieving HbA1c Target of <=6.0%, Percentage of subjects achieving HbA1c target values of \<=6.0% at Week 30., Week 30|Exenatide LAR Steady State Concentration From Week 29 to Week 30, Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported., Week 29 to Week 30|Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14, Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14, Day -3, Week 14|Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose), Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events., Week 22|Change in Body Weight From Baseline to Week 30, Change in body weight from baseline (Day -3) to Week 30, Day -3, Week 30|Change in Body Weight From Baseline to Week 364, Change in body weight from baseline (Day -3) to Week 364, Day -3, Week 364|Change in Fasting Plasma Glucose From Baseline to Week 30, Change in fasting plasma glucose from baseline (Day -3) to Week 30., Day -3, Week 30|Change in Fasting Plasma Glucose From Baseline to Week 364, Change in fasting plasma glucose from baseline (Day -3) to Week 364., Day -3, Week 364|Change in Blood Pressure From Baseline to Week 30, Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30, Day -3, Week 30|Change in Blood Pressure From Baseline to Week 364, Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364, Day -3, Week 364|Change in Total Cholesterol From Baseline to Week 30, Change in total cholesterol from baseline (Day -3) to Week 30., Day -3, Week 30|Change in Total Cholesterol From Baseline to Week 364, Change in total cholesterol from baseline (Day -3) to Week 364., Day -3, Week 364|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30, Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30., Day -3, Week 30|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364, Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364., Day -3, Week 364|Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364, Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364., Day -3, Week 364|Ratio of Triglycerides at Week 30 to Baseline, Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline., Day -3, Week 30|Ratio of Triglycerides at Week 364 to Baseline, Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline., Day -3, Week 364|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening, The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia., Day 1 to Week 364|Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening, The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia., Day 1 to Week 364
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| Sponsor/Collaborators: |
Sponsor: AstraZeneca
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| Gender: |
ALL
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| Age: |
CHILD, ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
303
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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: |
2006-04
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| Completion Date: |
2014-08
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| Results First Posted: |
2012-08-17
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| Last Update Posted: |
2015-08-26
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| Locations: |
Research Site 182, Encino, California, 91436, United States|Research Site 171, La Jolla, California, 92037, United States|Research Site 518, San Diego, California, 92161, United States|Research Site 024, Walnut Creek, California, 94598, United States|Research Site, Colorado Springs, Colorado, United States|Research Site 057, Miami, Florida, 33156, United States|Research Site, Chicago, Illinois, United States|Research Site 149, Indianapolis, Indiana, 46254, United States|Research Site 099, Lexington, Kentucky, 40503, United States|Research Site 017, Detroit, Michigan, 48202, United States|Research Site 224, Minneapolis, Minnesota, 55416, United States|Research Site 312, St. Louis, Missouri, 63141, United States|Research Site 023, Butte, Montana, 59701, United States|Research Site 053, Rochester, New York, 14609, United States|Research Site 002, Durham, North Carolina, 27713, United States|Research Site 123, Winston-Salem, North Carolina, 27103, United States|Research Site 405, Cincinnati, Ohio, 45219, United States|Research Site 557, Marion, Ohio, 43302, United States|Research Site 231, Portland, Oregon, 97239, United States|Research Site 152, Philadelphia, Pennsylvania, 19146, United States|Research Site 587, Greer, South Carolina, 29651, United States|Research Site 015, Dallas, Texas, 75230, United States|Research Site 009, San Antonio, Texas, 78229, United States|Research Site 108, Olympia, Washington, 98502, United States|Research Site, Toronto, Ontario, Canada
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| URL: |
https://clinicaltrials.gov/show/NCT00308139
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