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Clinical Trial Details

Trial ID: L4659
Source ID: NCT01854723
Associated Drug: Switching To Nph Insulin
Title: Comparison Study of Insulin Glargine and NPH Insulin
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Diabetes
Interventions: DRUG: Switching to NPH insulin|DRUG: Continuation of insulin glargine
Outcome Measures: Primary: Difference in A1C between groups at 6 months, 6 months | Secondary: Difference in A1C between groups at 3 months, 3 months|Difference in self-monitored blood glucose averages between groups, Outside of A1C, the investigators will also be comparing self-monitored blood glucose averages within each group and comparing them to one another., 6 months|Difference in incidence of hypoglycemia between each group, * Mild = symptoms consistent with hypoglycemia during which the subject was able to self-treat and was associated with blood glucose \< 70mg/dL * Severe = symptoms consistent with hypoglycemia during which the subject required the assistance of another person and was associated with either a glucose level \< 56 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon * Nocturnal hypoglycemia = hypoglycemia as described above occurring after the subject goes to bed and before the measurement of glucose, eating breakfast, or administration of any glucose-lowering agent in the morning, 6 months|Difference in units of basal insulin used per day between groups, 6 months|Difference in total units of insulin per day between groups, 6 months|Difference in percent of patients who require initiation/titration of prandial insulin between each group, 6 months|Difference in rate of mortality in each group during study period, 6 months|Difference in morbidity between each group during study period, Morbidity defined as glycemia-related hospitalizations, ER visits, immediate care clinic visits (hypoglycemia, hyperglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic nonketotic syndrome, hospitalizations diagnosed as related to diabetes with diagnosis code), 6 months|Compare cost of insulin therapy over study period at study completion, Costs will be calculated as direct patient cost and total cost of medication., 6 months|Differences in change in weight during study period between groups, Weight change in each patient will be calculated using weight at study initiation and completion, 6 months|Difference in number of visits with clinical pharmacist, 6 months
Sponsor/Collaborators: Sponsor: Providence Health & Services
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-04
Completion Date: 2015-12
Results First Posted:
Last Update Posted: 2020-03-10
Locations: Providence Medical Group Northeast Clinic, Portland, Oregon, 97213, United States
URL: https://clinicaltrials.gov/show/NCT01854723