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Clinical Trial Details

Trial ID: L4303
Source ID: NCT00998335
Associated Drug: Long-Acting Bedtime Insulin Detemir (Levemir)
Title: Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00998335/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Long-acting bedtime insulin detemir (Levemir)|DRUG: Insulin detemir and pre-meal insulin aspart.
Outcome Measures: Primary: Hepatic Steatosis, Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS)., 3 and 6 months | Secondary: Metabolic Control as Measured by the A1c, 3 and 6 months|Change in Insulin Secretion, Derived from the hyperglycemic clamp (Plasma C-peptide change vs. pretreatment in first and second phase)., 3 and 6 months.|Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS)., Percent intramyocellular (IMCL) by magnetic resonance imaging and spectroscopy (MRS)., 3 and 6 months.|Plasma Lipid Concentration., Fasting plasma lipid concentration on day of admission at 3 and 6 months., 3 and 6 months.|Change in Anthropometric Measure (Body Weight)., Change in anthropometric measure (body weight) done on day of admission at 3 and 6 months., 3 and 6 months.|Number of Hypoglycemic Events, Defined as hypoglycemia \<40 mg/dl and/or requiring medical assistance during the trial., 3 and 6 months|Metabolic Control as Measured by the Fasting Plasma Glucose Concentration, 3 and 6 months|Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile., 3 and 6 months|Advanced Lipid Testing, Change in lipoprotein particle number was determined using NMR., 3 and 6 months|Change in Anthropometric Measure (Body Mass Index [BMI])., Change in anthropometric measure (body mass index \[BMI\]) done on day of admission at 3 and 6 months., 3 and 6 months.|Percent Change From Baseline in Vascular Inflammatory Markers, Inflammatory Markers include: Adiponectin, MMP-9, E-selectin, sICAM, and sVCAM, 3 and 6 months
Sponsor/Collaborators: Sponsor: University of Florida | Collaborators: VA Office of Research and Development|Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-06
Completion Date: 2010-02
Results First Posted: 2016-07-29
Last Update Posted: 2016-09-28
Locations: The University of Texas H.S.C. at San Antonio and the San Antonio Audie L. Murphy VA Hospital, San Antonio, Texas, 78229-3900, United States
URL: https://clinicaltrials.gov/show/NCT00998335