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    The value on the web page has changed from 'Show more Show more Revision: v2.9.0' to 'Show less MedlinePlus Genetics related topics: Type 1 diabetes MedlinePlus related topics: Diabetes Type 1 Drug Information available for: Insulin Insulin human FDA Drug and Device Resources Show less Design Details Primary Purpose : Prevention Allocation : Randomized Interventional Model : Parallel Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : 67.5 mg oral insulin crystals daily 67.5 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given daily for six months Drug : 67.5 mg oral insulin crystals daily human insulin crystals in capsules Other Names: Humulin R crystals Experimental : 500mg oral insulin crystals every other week 500 mg oral insulin crystals in capsules (by mouth or sprinkled on food) given every other week for six months Drug : 500mg oral insulin crystals every other week human insulin crystals in capsules Other Names: Humulin R crystals Primary Outcome Measures Outcome Measure Measure Description Time Frame Change in GAD65 Autoantibody Titer (DK Units/mL) Change in T-lymphocyte (GAD65) biomarker of beta cell specific immune response 13 and 26 weeks after first dose versus baseline Change in mIAA Autoantibody Titer From Baseline Micro-islet autoantibodies (mIAA) autoantibody titers are a measure of of beta cell immune response 13 and 26 weeks after first dose versus baseline Keywords Provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) oral insulin Additional Relevant MeSH Terms Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Diabetes Mellitus, Type 1 Hypoglycemic Agents Physiological Effects of Drugs Central Nervous System Stimulants Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Uptake Inhibitors Insulin Insulin, Globin Zinc Insulin, Isophane Methamphetamine Plan to Share Individual Participant Data (IPD)? Yes IPD Plan Description Data will be available at the NIDDK Central Repository IPD Sharing Url https://repository.niddk.nih.gov/home/ Study Documents Provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Study Protocol and Statistical Analysis Plan [ PDF , 1.11MB, 2016-01-15 ] Revision: v2.9.1
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