Phase 2
Completed N=244
Memory Aid by Intranasal Insulin in Diabetes (MemAID)
Source: ClinicalTrials.gov NCT02415556 ↗Enrolled (actual)
244
Serious AEs
2.7%
Results posted
Sep 2021
Primary outcomePrimary: Gait Speed Normal Walk (cm/s). — 112.23; 103.42; 121.58; 119.51 cm/s — p=0.025
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gait Speed Normal Walk (cm/s). |
112.23; 103.42; 121.58; 119.51; 112.43; 105.83 | 0.025 sig |
| PRIMARY Gait Speed Dual-task (cm/s). |
104.23; 93.18; 109.44; 110.24; 105.34; 98.27 | 0.007 sig |
| PRIMARY Executive Function Composite z Score |
0.84; 1.40; 0.46; 0.66; 0.13; 0.47 | 0.144 |
| PRIMARY Verbal Memory Composite z Score |
-0.74; -0.89; 0.07; -0.22; -0.16; -0.50 | 0.149 |
| SECONDARY Fasting Plasma Glucose (mg/dL). |
138.63; 141.25; 92.07; 90.54; 140.47; 132.18 | 0.030 sig |
| SECONDARY Weight (kg). |
90.36; 90.96; 75.89; 76.40; 88.44; 93.79 | 0.576 |
Eligibility Criteria
Inclusion Criteria
- Men and women aged 50-85 years old
- Able to walk for 6 minutes
- Diabetes type 2 (DM) group: diagnosis and treatment for type 2 DM with non-insulin oral or injectable agents
- Non-DM group with similar age range as the DM group, non-diabetic fasting plasma glucose ( 1 asymptomatic and/or symptomatic episode of hypoglycemia (glucose 150 mg/dL will be excluded even without history of hypoglycemia during finger stick measurements.
Data sourced from ClinicalTrials.gov (NCT02415556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.