Clinical Trial Details
| Trial ID: | L4112 |
| Source ID: | NCT00229658 |
| Associated Drug: | Pramlintide Acetate |
| Title: | An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00229658/results |
| Conditions: | Type 1 Diabetes Mellitus|Type 2 Diabetes Mellitus |
| Interventions: | DRUG: pramlintide acetate |
| Outcome Measures: | Primary: Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period, PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention. The adjustment period represents the initial 0-3 months of pramlintide treatment, 0-3 months|Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Adjustment Period, The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment. PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention., 0-3 months | Secondary: The Incidence of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period, The steady state period represents the \>3-6 months of pramlintide treatment following the adjustment period. PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention., >3-6 months|The Annual Event Rate of Patient-Ascertained Severe Hypoglycemia (PASH) During the Steady State Period, The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the \>3-6 months of pramlintide treatment following the adjustment period. PASH is defined as episodes of hypoglycemia requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention., >3-6 months|Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period, MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH. The adjustment period represents the initial 0-3 months of pramlintide treatment, 0-3 months|The Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Adjustment Period, The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The adjustment period represents the initial 0-3 months of pramlintide treatment. MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH., 0-3 months|Incidence of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period, The steady state period represents the \>3-6 months of pramlintide treatment following the adjustment period. MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH., >3-6 months|Annual Event Rate of Medically Assisted Severe Hypoglycemia (MASH) During the Steady State Period, The annual event rate was calculated as the total number of events during the time period divided by the total years of exposure to pramlintide for all patients during the time period. The steady state period represents the \>3-6 months of pramlintide treatment following the adjustment period. MASH is defined as episodes of severe hypoglycemia requiring IM glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or is assessed as a serious adverse event (SAE) by the investigator. MASH is a subset of PASH., >3-6 months|Change in HbA1c From Baseline at Month 3, Change in HbA1c from baseline at month 3. The HbA1c test measures the percent of glycosylated hemoglobin in the blood., 3 months|Change in HbA1c From Baseline at Month 6, Change in HbA1c from baseline at month 6. The HbA1c test measures the percent of glycosylated hemoglobin in the blood., 6 months|Change in Body Weight From Baseline at Month 3, Mean change in body weight from baseline at month 3, 3 months|Change in Body Weight From Baseline at Month 6, Mean change in body weight from baseline at month 6, 6 months |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 1297 |
| Study Type: | OBSERVATIONAL |
| Study Designs: | Observational Model: |Time Perspective: p |
| Start Date: | 2005-09 |
| Completion Date: | 2008-05 |
| Results First Posted: | 2009-06-24 |
| Last Update Posted: | 2015-03-25 |
| Locations: | Research Site, Birmingham, Alabama, United States|Research Site, Montgomery, Alabama, United States|Research Site, Tucson, Arizona, United States|Research Site, Anaheim, California, United States|Research Site, Encinitas, California, United States|Research Site, Escondido, California, United States|Research Site, Fresno, California, United States|Research Site, Lafayette, California, United States|Research Site, Moreno Valley, California, United States|Research Site, Sacramento, California, United States|Research Site, Salinas, California, United States|Research Site, Santa Barbara, California, United States|Research Site, Torrance, California, United States|Research Site, Vacaville, California, United States|Research Site, Arvada, Colorado, United States|Research Site, Aurora, Colorado, United States|Research Site, Norwalk, Connecticut, United States|Research Site, Wilmington, Delaware, United States|Research Site, Hialeah, Florida, United States|Research Site, Jacksonville, Florida, United States|Research Site, Maitland, Florida, United States|Research Site, Melbourne, Florida, United States|Research Site, Miami, Florida, United States|Research Site, Plantation, Florida, United States|Research Site, Tallahassee, Florida, United States|Research Site, Winter Haven, Florida, United States|Research Site, Canton, Georgia, United States|Research Site, Columbus, Georgia, United States|Research Site, Roswell, Georgia, United States|Research Site, Valdosta, Georgia, United States|Research Site, Aiea, Hawaii, United States|Research Site, Caldwell, Idaho, United States|Research Site, Idaho Falls, Idaho, United States|Research Site, Pocatello, Idaho, United States|Research Site, Evergreen Park, Illinois, United States|Research Site, Wheaton, Illinois, United States|Research Site, Fort Wayne, Indiana, United States|Research Site, Franklin, Indiana, United States|Research Site, Indianapolis, Indiana, United States|Research Site, Des Moines, Iowa, United States|Research Site, Shawnee Mission, Kansas, United States|Research Site, Wichita, Kansas, United States|Research Site, Louisville, Kentucky, United States|Research Site, Baton Rouge, Louisiana, United States|Research Site, Lafayette, Louisiana, United States|Research Site, Laplace, Louisiana, United States|Research Site, Glen Burnie, Maryland, United States|Research Site, Towson, Maryland, United States|Research Site, Ann Arbor, Michigan, United States|Research Site, Bloomfield, Michigan, United States|Research Site, Detroit, Michigan, United States|Research Site, Grand Rapids, Michigan, United States|Research Site, Duluth, Minnesota, United States|Research Site, Eagan, Minnesota, United States|Research Site, Butte, Montana, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Reno, Nevada, United States|Research Site, Hamilton, New Jersey, United States|Research Site, Jersey City, New Jersey, United States|Research Site, Livingston, New Jersey, United States|Research Site, Moorestown, New Jersey, United States|Research Site, Neptune, New Jersey, United States|Research Site, North Plainfield, New Jersey, United States|Research Site, Albany, New York, United States|Research Site, Binghamton, New York, United States|Research Site, Forest Hills, New York, United States|Research Site, Lawrence, New York, United States|Research Site, New York, New York, United States|Research Site, Riverhead, New York, United States|Research Site, Rochester, New York, United States|Research Site, Staten Island, New York, United States|Research Site, Utica, New York, United States|Research Site, Greensboro, North Carolina, United States|Research Site, Morehead City, North Carolina, United States|Research Site, Raleigh, North Carolina, United States|Research Site, Cincinnati, Ohio, United States|Research Site, Columbus, Ohio, United States|Research Site, Mentor, Ohio, United States|Research Site, Toledo, Ohio, United States|Research Site, Portland, Oregon, United States|Research Site, Salem, Oregon, United States|Research Site, Bridgeville, Pennsylvania, United States|Research Site, Carlisle, Pennsylvania, United States|Research Site, Erie, Pennsylvania, United States|Research Site, Sewickley, Pennsylvania, United States|Research Site, Columbia, South Carolina, United States|Research Site, Orangeburg, South Carolina, United States|Research Site, Sumter, South Carolina, United States|Research Site, Chattanooga, Tennessee, United States|Research Site, Hendersonville, Tennessee, United States|Research Site, Hixon, Tennessee, United States|Research Site, Memphis, Tennessee, United States|Research Site, Nashville, Tennessee, United States|Research Site, Austin, Texas, United States|Research Site, Beaumont, Texas, United States|Research Site, Houston, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Provo, Utah, United States|Research Site, Salt Lake City, Utah, United States|Research Site, McLean, Virginia, United States|Research Site, Norton, Virginia, United States|Research Site, Puyallup, Washington, United States|Research Site, Seattle, Washington, United States|Research Site, Spokane, Washington, United States|Research Site, Tacoma, Washington, United States|Research Site, Walla Walla, Washington, United States|Research Site, Milwaukee, Wisconsin, United States |
| URL: | https://clinicaltrials.gov/show/NCT00229658 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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