| Trial ID: | L2233 |
| Source ID: | NCT00135330
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| Associated Drug: |
Exenatide
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| Title: |
An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus
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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/NCT00135330/results
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: exenatide|DRUG: rosiglitazone
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| Outcome Measures: |
Primary: Change in ASIiAUC During a Hyperglycemic Clamp Test., Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function., 20 weeks | Secondary: Change in AUC for Glucose During a Meal Challenge Test (MCT)., Change in AUC(15-180 min) for glucose during a MCT baseline to week 20., Week 20|Change in Insulin Sensitivity Index as Measured by M-value., Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20., Week 20|Change in Insulin AUC in the First Stage From Baseline to Endpoint., Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test., Week 20|Change in Insulin iAUC From Baseline to Endpoint., Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test., Week 20|Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT)., Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT., Week 20|Change in AUC for C-peptide During a Meal Challenge Test (MCT)., Ratio (value at endpoint divided by value at baseline) of AUC(15-180 min) for C-peptide (nmol-min/L) during a MCT from baseline to week 20., Week 20|Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT)., Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20., Week 20|Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT)., Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20., Week 20|Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT)., Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20., Week 20|Change in HbA1c, Change in HbA1c from baseline to week 20., Week 20|Change in Fasting Serum Glucose Concentration., Change in fasting serum glucose concentration from baseline to week 20., Week 20|Change in Fasting C-peptide, Change in fasting C-peptide from baseline to week 20., Week 20|Change in Fasting Insulin, Change in fasting insulin from baseline to week 20., Week 20|Change in Fasting Proinsulin, Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline, Week 20|Change in Body Weight, Change in body weight from baseline to week 20., Week 20|Change in Fasting Total Cholesterol., Change in fasting total cholestrol from baseline to week 20., Week 20|Change in Fasting HDL Cholesterol, Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20., Week 20|Change in Fasting LDL Cholesterol, Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20., Week 20|Change in Fasting Triglycerides, Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20., Week 20|Change in Percent Body Fat During a Meal Challenge Test (MCT), Change in percent body fat from baseline to week 20, as assessed during an MCT, 20 weeks|Change in Body Fat Mass During a Meal Challenge Test (MCT), Change in body fat mass form baseline to week 20, as assessed during an MCT, 20 weeks|Change in Lean Body Mass During a Meal Challenge Test (MCT), Change in lean body mass from baseline to week 20, as assessed during an MCT, 20 weeks|Change in Waist Circumference, Change in waist circumference from baseline to week 20, 20 weeks|Change in Hip Circumference, Change in hip circumference form baseline to week 20, 20 weeks|Change in Waist-to-hip Ratio, Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20, 20 weeks|Incidence of Hypoglycemia Events, Number of subjects experiencing hypoglycemia at any point during the study, 20 weeks|Hypoglycemia Rate Per 30 Days Per Patient, Average number of episodes of hypoglycemia per 30 days per patient, 20 weeks|Pedal Edema Score, Pedal edema scores experienced by each patient throughout the study ("1+" indicates a patient experienced a pedal edema score of 1 , 2, or 3; "2+" indicates a patient experienced a pedal edema score of 2 or 3, etc.) Scale: 1. Slight pitting, no visible distortion, disappears rapidly 2. A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 - 15 seconds 3. The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen 4. The pit is very deep, lasts as long as 2 - 5 minutes, and the dependent extremity is grossly distorted, 20 weeks
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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: |
137
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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: |
2005-10
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| Completion Date: |
2008-07
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| Results First Posted: |
2009-08-28
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| Last Update Posted: |
2015-04-07
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| Locations: |
Research Site, Phoenix, Arizona, United States|Research Site, San Francisco, California, United States|Research Site, Jacksonville, Florida, United States|Research Site, Orlando, Florida, United States|Research Site, Atlanta, Georgia, United States|Research Site, Honolulu, Hawaii, United States|Research Site, Indianapolis, Indiana, United States|Research Site, Boston, Massachusetts, United States|Research Site, Pittsfield, Massachusetts, United States|Research Site, Minneapolis, Minnesota, United States|Research Site, Rochester, Minnesota, United States|Research Site, Bronx, New York, United States|Research Site, Syracuse, New York, United States|Research Site, Cincinatti, Ohio, United States|Research Site, League City, Texas, United States|Research Site, New Braunfels, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Renton, Washington, United States|Research Site, Spokane, Washington, United States
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| URL: |
https://clinicaltrials.gov/show/NCT00135330
|
