Clinical Trial Details
| Trial ID: | L2470 |
| Source ID: | NCT00814294 |
| Associated Drug: | Placebo |
| Title: | Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes |
| Interventions: | DRUG: placebo|DRUG: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)|DRUG: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5) |
| Outcome Measures: | Primary: The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment., 18 weeks | Secondary: To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test, 18 weeks|To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin, 18 weeks|To evaluate the effects of oral HDV-I versus placebo on the homeostasis model assessment of insulin resistance (HOMA-IR)and homeostasis model assessment of β-cell function (HOMA-β), 18 Weeks|To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels, 18 Weeks |
| Sponsor/Collaborators: | Sponsor: Diasome Pharmaceuticals |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2|PHASE3 |
| Enrollment: | 239 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2008-12 |
| Completion Date: | 2009-09 |
| Results First Posted: | |
| Last Update Posted: | 2021-05-26 |
| Locations: | Muscle Shoals, Alabama, 35661, United States|Litchfield Park, Arizona, 85340, United States|Tucson, Arizona, 85712, United States|Concord, California, 94520, United States|Paramount, California, 90723, United States|Sacramento, California, 95825, United States|San Mateo, California, 94401, United States|Stockton, California, 95204, United States|Valley Village, California, 91607, United States|Walnut Creek, California, 94598, United States|Chiefland, Florida, 32626, United States|Fort Lauderdale, Florida, 33308, United States|Palm Harbor, Florida, 34684, United States|Pembroke Pines, Florida, 33029, United States|Atlanta, Georgia, 30308, United States|Atlanta, Georgia, 30322, United States|Topeka, Kansas, 66606, United States|Lexington, Kentucky, 40504, United States|Paducah, Kentucky, 42003, United States|Brockton, Massachusetts, 02301, United States|Picayune, Mississippi, 39466, United States|Omaha, Nebraska, 68114, United States|Staten Island, New York, 10301, United States|Cincinnati, Ohio, 45236, United States|Delaware, Ohio, 43015, United States|Zanesville, Ohio, 43701, United States|Beaver, Pennsylvania, 15009, United States|Kingsport, Tennessee, 37660, United States|Corpus Christi, Texas, 78404, United States|El Paso, Texas, 79935, United States|Houston, Texas, 77074, United States|Hurst, Texas, 76054, United States|Odessa, Texas, 79761, United States|San Antonio, Texas, 78229, United States|San Antonio, Texas, 78237, United States|Salt Lake City, Utah, 84124, United States|Manassas, Virginia, 20110, United States|Virginia Beach, Virginia, 23454, United States|Renton, Washington, 98055, United States|Milwaukee, Wisconsin, 53209, United States |
| URL: | https://clinicaltrials.gov/show/NCT00814294 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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