Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02415556 | Memory Aid by Intranasal Insulin in Diabetes (MemAID) | PHASE2 | COMPLETED | 289 | — | — | Oct 6, 2015 | May 31, 2020 | May 19, 2022 | 2 | United States |
Gait speed normal walk (cm/s) - difference between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo, Control - Insulin vs. Control - Placebo.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Type 2 Diabetes Mellitus - Insulin | EXPERIMENTAL | 40 IU of regular human insulin once daily over 24 weeks |
| Type 2 Diabetes Mellitus - Placebo | PLACEBO_COMPARATOR | Intranasal sterile saline once daily over 24 weeks |
| Control - Insulin | EXPERIMENTAL | 40 IU of regular human insulin once daily over 24 weeks |
| Control - Placebo | PLACEBO_COMPARATOR | Intranasal sterile saline once daily over 24 weeks |
| Name | Type | Description |
|---|---|---|
| Regular Human Insulin | DRUG | Regular human insulin 40 IU daily over 24 weeks |
| Placebo | DRUG | Intranasal sterile saline 40 IU daily over 24 weeks |
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 (\<126 mg/d...