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Clinical Trial Details

Trial ID: L6407
Source ID: NCT02415556
Associated Drug: Regular Human Insulin
Title: Memory Aid by Intranasal Insulin in Diabetes (MemAID)
Acronym: MemAID
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02415556/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Regular Human Insulin|DRUG: Placebo
Outcome Measures: Primary: Gait Speed Normal Walk (cm/s)., Gait speed normal walk (cm/s) - difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo., Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).|Gait Speed Dual-task (cm/s)., Gait speed dual-task (cm/s) - walking and counting backwards (subtracting 7) difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo., Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).|Executive Function Composite z Score, The executive function composite score was calculated as a sum of Paired Associates Learning (PAL) and Spatial Working Memory (SWM) z-scores (range -2 to +2, 0 indicates the mean; higher score indicates worse outcome). Paired Associates Learning - raw score of Total Errors Adjusted (range 0-120) was converted to z-score. Spatial Working Memory - raw score SWM-Between Errors (range 0-42) and raw score of SWM-Strategy (range 8-56) were converted to z-scores. Executive function composite scores were compared between: Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo., Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).|Verbal Memory Composite z Score, Verbal memory composite score was calculated as the sum of Verbal Recognition Memory (VRM) z scores ( 0 indicates the mean; lower score indicates worse outcome). VRM- Free Recall raw score (range 0-12), immediate and delayed VRM-Recognition raw score (range 0-24) were converted to z-scores. Verbal memory composite scores were compared between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo., Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48). | Secondary: Fasting Plasma Glucose (mg/dL)., Long-term safety measure of fasting plasma glucose difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo., Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48).|Weight (kg)., Long-term safety measure of weight difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo., Measured at baseline, on-treatment (V2-intervention week 1, V4 week 8, V6 week 16, V8 week 24) and post-treatment (V9-week 25, V10-week 32, V11-week 40, V12-week 48). | Other: Cerebral Blood Flow on Magnetic Resonance Imaging (MRI)., Difference in regional cerebral blood flow in right medial prefrontal cortex (MPFC) was measured by pseudo-continuous arterial spin labeling (PCASL) MRI at 3 Tesla in 8 Type 2 Diabetes Mellitus - Insulin participants and 3 Type 2 Diabetes Mellitus - Placebo participants only., At baseline and at V8 (week 24) the last intervention.
Sponsor/Collaborators: Sponsor: Beth Israel Deaconess Medical Center | Collaborators: Novo Nordisk A/S|Medtronic|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 289
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-10-06
Completion Date: 2020-05-31
Results First Posted: 2021-09-17
Last Update Posted: 2022-05-19
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States|Vera Novak, Boston, Massachusetts, 02215, United States
URL: https://clinicaltrials.gov/show/NCT02415556