CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Intranasal insulin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01206322
NCT01206322Phase 2Completed
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Enhancement of Cerebral Vasoreactivity and Cognition by Intranasal Insulin in Type 2 Diabetes

Beth Israel Deaconess Medical Center·interventional·Posted Sep 21, 2010·Updated Jun 26, 2019

In Brief

A Phase 2 clinical trial evaluating Intranasal insulin and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Our goal is to determine the acute effects of intranasal insulin on regional perfusion and cognition of older adults. We propose a pilot study to examine the effect of a single dose of intranasal insulin on regional vasoreactivity and cognitive functions in 30 subjects with T2DM and 30 healthy controls \>50 years old using a double blinded, placebo-controlled, cross-over design. Hypothesis 1: Intranasal insulin improves acutely regional perfusion and vasoreactivity in older patients with T2DM as compared with placebo and compared with the control group. Hypothesis 2: Intranasal insulin improves cognitive functioning including attention, memory and executive function in diabetic patients as compared with placebo and compared with control group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
CollaboratorsBoston University, Joslin Diabetes Center, Peking University, University of Washington, University of Arkansas, VA Boston Healthcare System, University of Massachusetts, Worcester, Wake Forest University

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2010
Enrollment StartMay 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.8 years ago

Interventions

Intranasal insulindrug

The acute effects of a single 40-IU dose of intranasal insulin

Placebodrug

The acute effects of intranasal sterile saline.