CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 289 enrolled
Drug / intervention
Regular Human Insulin +1 moredrug
Likely dose
Regular Human Insulin 40 IUfrom 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/NCT02415556
NCT02415556Phase 2Completed

Memory Advancement by Intranasal Insulin in Type 2 Diabetes

Beth Israel Deaconess Medical Center·interventional·Posted Apr 14, 2015·Updated May 19, 2022

In Brief

A Phase 2 clinical trial evaluating Regular Human Insulin and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 289 participants across 2 sites.

Detailed Summary

The main purpose of this study is to find the long-term effects of daily administration of 40 IU of intranasal insulin (INI) as compared to placebo (sterile saline) on cognition and memory in people with type 2 diabetes mellitus (DM), and non-diabetic controls over 24 weeks with a follow-up period for 24 weeks. Four groups will be tested: DM group treated with INI; DM group treated with placebo; control group treated with INI and the control group treated with placebo. The INI or placebo will be delivered into the nose. The investigators are interested to see whether INI can improve memory and cognition and blood flow in the brain in the type 2 DM group as compared to placebo and to the non-diabetic group over a long-term period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 14, 2015
Enrollment StartOct 6, 2015
Primary CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 11.2 years ago

Interventions

Regular Human Insulindrug

Regular human insulin 40 IU daily over 24 weeks

Placebodrug

Intranasal sterile saline 40 IU daily over 24 weeks