A Phase 1/2 interventional study of Insulin, intranasal and Placebo, intranasal in HIV Dementia and HIV-Associated Cognitive Motor Complex, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by Johns Hopkins University · Phase 1/2, Interventional, and Treatment
Infection with HIV (the virus that causes AIDS) can lead to problems with brain function, such as memory, concentration, judgment, and the speed or control of hands and legs. Neurologists have called this condition HIV-associated neurocognitive disorder (HAND). This research is being done to see if insulin taken through the nose as a spray (intranasal insulin) can help people with HIV who are having problems with memory and brain function, or HAND.
Participants will be given either insulin or placebo. A placebo is an inactive substance that looks like the study drug, but does not contain study drug. For this research study, the placebo will be a clear, saline-based liquid spray that looks like the insulin spray but has no insulin. Participants will not be told whether they receive insulin or placebo during the study.
All participants will take the intranasal spray twice a day, about 30 minutes after a meal. Participants will use a specialized intranasal drug administration device. The total daily dose of insulin is 40 IU split between 20 IU in the morning and 20 IU in the evening. Participants will take the intranasal spray for 24 weeks.
The researchers will record symptoms and side effects during the study. Procedures include neurocognitive testing of memory and brain function, two optional lumbar punctures ("spinal taps"), two MRI brain scans, monthly blood draws, and clinical assessments.
HIV-associated neurocognitive disorders (HAND) are characterized by disabling cognitive, behavioral, and motor dysfunction and can occur in individuals with HIV even while taking combination antiretroviral therapy (ART). The mechanisms for these residual impairments are not fully understood, but appear to involve poor penetrance of ART drugs into the central nervous system (CNS) and the resulting brain sanctuary for inadequately suppressed HIV infection with associated sustained inflammation. Adjunctive therapies with targeted neuroprotective agents are critically needed for the treatment of HAND. Insulin is involved in multiple CNS functions including food intake, metabolism, learning, and memory. Insulin has neuroprotective properties demonstrated in cell culture experiments and in vivo models, which provide strong evidence for its use as a therapeutic agent to treat HAND.
Insulin modifying therapy (IMT) includes intranasal insulin administered by a novel nasal drug delivery device. IMT may play important roles in neuronal plasticity and survival by protecting hippocampal neurons against oxidative stress and apoptotic cell death induced by glutamate neurotoxicity. Previous studies support the proposed early phase trial of IMT as a novel therapeutic agent for HAND.
This double-blinded placebo-controlled clinical trial evaluates safety of intranasal insulin at the daily dose of 40 IU and will provide initial data for assessing safety and efficacy. The protocol measures safety by incidence and frequency of adverse events. Clinical effects of IMT over the 24-week trial period are measured by change in neurocognitive and functional testing results, as well as several novel radiological and cerebrospinal fluid (CSF) surrogate markers. Outcomes from these studies could have important implications for the design of future studies with IMT and other neuroprotective compounds for HAND.
41 studies on the registry are indexed under AIDS Dementia Complex; 2 are open to participants now.
This study's enrollment of 21 is below the median of 50 across 31 interventional studies indexed under AIDS Dementia Complex.
Browse AIDS Dementia Complex studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Regular insulin, 20 IU intranasal twice a day for 24 weeks; 0.2 mL per dose
Drug: Insulin, intranasal
Saline solution (placebo), intranasal twice a day for 24 weeks; 0.2 mL per dose
Drug: Placebo, intranasal
Regular insulin administered by specialized, non-commercial intranasal drug delivery device
Also known as: Novolin R
Saline solution administered by specialized, non-commercial intranasal drug delivery device
Serious Adverse Event Frequency
Number of documented serious adverse events per participant, mean
Time frame: Total during 24-week trial
Serious Adverse Event Frequency, Participant Count
Number participants with at least one documented serious adverse event, count
Time frame: Total during 24-week trial
Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score
Change in GDS, measured at two time points, baseline and Week 24 visits. GDS is a composite score based on neurocognitive test performance. The 14 data points that comprise the GDS include Hopkins Verbal Learning Test (trials 1-3 total score and delayed recall), Rey Complex Figure Test (copy and delayed recall), WAIS symbol-digit test, grooved pegboard (dominant and non-dominant), CalCAP (Choice reaction time and Sequential reaction time), Trail-making Test (Parts A and B), Stroop Color Interference Test (trial 3), timed gait (3 trials average), and verbal fluency (FAS). Raw scores were transformed to t-scores using age/education stratified normative data, then assigned a discrete value from 0 to 5 using the following t-score categorization: \> or = 40 is '0', 35.00 to 39.99 is '1', 30.00 to 34.99 is '2', 25.00 to 29.99 is '3', 20.00 to 24.99 is '4', and \<20 is '5'. The 14 individual scores were then averaged. A higher GDS is a worse outcome (0 = no deficits and 5 = maximum deficits).
Time frame: Difference between baseline and week 24 visits
Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score
NPZ-8 score at 24 weeks minus baseline NPZ-8 score: The NPZ-8 is an average of 8 individual Z-scores, where higher values indicate greater neurocognitive performance (better outcome). The NPZ-8 represents the number of standard deviations an individual's performance is away from the mean (Z-score = 0) of age and education matched reference populations where performance worse than the mean had negative Z-scores (i.e. Z-scores were inverted for tests scored on speed). The NPZ-8 average is comprised of 8 data points from 6 tests: timed gait, WAIS symbol-digit, grooved pegboard dominant \& non-dominant, CalCAP Choice \& Sequential reaction times, and the Trail-making Test parts A \& B. Raw scores were transformed to Z-scores for each test and then averaged to calculate the NPZ-8 score at each visit (Z-scores +/-3.5 standard deviations from mean limited to +/-3.5). Positive change in NPZ-8 from baseline to Week 24 indicated improved performance and negative change indicated worse performance.
Time frame: Difference between baseline and week 24 visits
CSF Biomarkers, Week 24 Visit Value Minus Baseline Value
Changes in cerebrospinal fluid (CSF) concentrations of ceramide, sphingomyelin, citrate, neurofilament protein; brain-derived neurotrophic factor (BDNF), protein carbonyl, Aβ-42
Time frame: Between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Myoinositol, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in the basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Myoinositol, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Choline, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, Choline, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Basal Ganglia, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Frontal White Matter, Week 24 Visit Value Minus Baseline Value
Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: DTI, Whole Brain Mean Fractional Anisotropy (FA), Week 24 Visit Value Minus Baseline Value
Diffusion tensor imaging (DTI), change in whole brain fractional anisotropy (FA) between baseline and 24 weeks. FA is a unitless index that is used for measuring diffusion asymmetry. FA values range from 0 to 1 (0 equals no anisotropy; greater anisotropy is indicated by higher FA values approaching the maximum of 1). FA was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean FA = (Sum of (each ROI's FA \* volume)) / (Sum of all ROI volumes).
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: Diffusion Weighted Imaging, Whole Brain Mean Diffusivity, Week 24 Visit Value Minus Baseline Value
Diffusion weighted imaging, change in whole brain mean diffusivity (MD) between baseline and 24 weeks. MD was measured as the mean of three eigenvalues and has the unit m\^2/s. Higher values indicate greater diffusivity. MD was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean MD = (Sum of (each ROI's MD \* volume)) / (Sum of all ROI volumes).
Time frame: Changes between baseline and week 24 visits
Neuroimaging Markers: ASL, Week 24 Visit Value Minus Baseline Value
Arterial spin labeling (ASL), a novel measure of cerebral blood flow
Time frame: Changes between baseline and week 24 visits
| Milestone | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Started | 10 | 11 |
| Primary outcome 1 (sae) | 10 | 11 |
| Secondary measures collected at week 24 | 8 | 9 |
| Completed (itt): primary outcome 2 (gds) | 7 | 9 |
| Completed | 6 | 8 |
| Not completed | 4 | 3 |
Number of documented serious adverse events per participant, mean
| Number of SAEs/participant | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Enrolled | 0.30 ± 0.67 | 0.18 ± 0.40 |
| Completed Trial (ITT) | 0.14 ± 0.38 | 0.22 ± 0.44 |
| Completed Trial (Per Protocol) | 0.00 ± 0.00 | 0.25 ± 0.46 |
Number participants with at least one documented serious adverse event, count
| Participants | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Enrolled | 2 | 2 |
| Completed Trial (ITT) | 1 | 2 |
| Completed Trial (Per Protocol) | 0 | 2 |
Change in GDS, measured at two time points, baseline and Week 24 visits. GDS is a composite score based on neurocognitive test performance. The 14 data points that comprise the GDS include Hopkins Verbal Learning Test (trials 1-3 total score and delayed recall), Rey Complex Figure Test (copy and delayed recall), WAIS symbol-digit test, grooved pegboard (dominant and non-dominant), CalCAP (Choice reaction time and Sequential reaction time), Trail-making Test (Parts A and B), Stroop Color Interference Test (trial 3), timed gait (3 trials average), and verbal fluency (FAS). Raw scores were transformed to t-scores using age/education stratified normative data, then assigned a discrete value from 0 to 5 using the following t-score categorization: \> or = 40 is '0', 35.00 to 39.99 is '1', 30.00 to 34.99 is '2', 25.00 to 29.99 is '3', 20.00 to 24.99 is '4', and \<20 is '5'. The 14 individual scores were then averaged. A higher GDS is a worse outcome (0 = no deficits and 5 = maximum deficits).
| units on a scale | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Completed Trial (ITT) | -0.1614 ± 0.3810 | 0.2300 ± 0.2981 |
| Completed Trial (Per Protocol) | -0.2383 ± 0.3529 | 0.2763 ± 0.2820 |
NPZ-8 score at 24 weeks minus baseline NPZ-8 score: The NPZ-8 is an average of 8 individual Z-scores, where higher values indicate greater neurocognitive performance (better outcome). The NPZ-8 represents the number of standard deviations an individual's performance is away from the mean (Z-score = 0) of age and education matched reference populations where performance worse than the mean had negative Z-scores (i.e. Z-scores were inverted for tests scored on speed). The NPZ-8 average is comprised of 8 data points from 6 tests: timed gait, WAIS symbol-digit, grooved pegboard dominant \& non-dominant, CalCAP Choice \& Sequential reaction times, and the Trail-making Test parts A \& B. Raw scores were transformed to Z-scores for each test and then averaged to calculate the NPZ-8 score at each visit (Z-scores +/-3.5 standard deviations from mean limited to +/-3.5). Positive change in NPZ-8 from baseline to Week 24 indicated improved performance and negative change indicated worse performance.
| z-score | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Completed Trial (ITT) | -0.09 ± 0.39 | -0.01 ± 0.57 |
| Completed Trial (Per Protocol) | -0.07 ± 0.42 | -0.02 ± 0.60 |
Changes in cerebrospinal fluid (CSF) concentrations of ceramide, sphingomyelin, citrate, neurofilament protein; brain-derived neurotrophic factor (BDNF), protein carbonyl, Aβ-42
No measurements were reported for this outcome.
Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in the basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
| mmol/L, approx. (institutional units) | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Available MRS Secondary Outcomes | 0.7855 ± 0.8485 | 0.4759 ± 0.8174 |
| Completed Trial (Per Protocol) | 0.5373 ± 0.8859 | 0.3022 ± 0.7404 |
Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
| mmol/L, approx. (institutional units) | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Available MRS Secondary Outcomes | 0.2617 ± 1.8493 | 0.2155 ± 1.1215 |
| Completed Trial (Per Protocol) | 0.6063 ± 2.1711 | 0.0382 ± 1.1560 |
Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
| mmol/L, approx. (institutional units) | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Available MRS Secondary Outcomes | -0.1495 ± 0.3583 | 0.1907 ± 0.4769 |
| Completed Trial (Per Protocol) | -0.1905 ± 0.4548 | 0.1162 ± 0.4757 |
Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
| mmol/L, approx. (institutional units) | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Available MRS Secondary Outcomes | 0.1670 ± 0.3430 | -0.1557 ± 0.2130 |
| Completed Trial (Per Protocol) | 0.2028 ± 0.4017 | -0.2128 ± 0.1795 |
Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units).
| mmol/L, approx. (institutional units) | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Available MRS Secondary Outcomes | -0.5572 ± 0.9270 | -0.1870 ± 0.8497 |
| Completed Trial (Per Protocol) | -0.7895 ± 1.1018 | -0.2915 ± 0.8801 |
Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units).
| mmol/L, approx. (institutional units) | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Available MRS Secondary Outcomes | 0.1050 ± 1.7154 | 0.1432 ± 0.6497 |
| Completed Trial (Per Protocol) | 0.2597 ± 2.1606 | 0.1134 ± 0.7218 |
Diffusion tensor imaging (DTI), change in whole brain fractional anisotropy (FA) between baseline and 24 weeks. FA is a unitless index that is used for measuring diffusion asymmetry. FA values range from 0 to 1 (0 equals no anisotropy; greater anisotropy is indicated by higher FA values approaching the maximum of 1). FA was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean FA = (Sum of (each ROI's FA \* volume)) / (Sum of all ROI volumes).
| index | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| All Available | -0.0011885 ± 0.0055178 | -0.0043236 ± 0.0071927 |
| Per Protocol | -0.0022483 ± 0.0035673 | -0.0048070 ± 0.0076274 |
Diffusion weighted imaging, change in whole brain mean diffusivity (MD) between baseline and 24 weeks. MD was measured as the mean of three eigenvalues and has the unit m\^2/s. Higher values indicate greater diffusivity. MD was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean MD = (Sum of (each ROI's MD \* volume)) / (Sum of all ROI volumes).
| m^2/s | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| All Available | 4.7274*10^-6 ± 1.9275*10^-5 | 4.1177*10^-6 ± 6.2060*10^-5 |
| Per Protocol | 5.8845*10^-6 ± 2.2223*10^-5 | 1.1278*10^-5 ± 6.3362*10^-5 |
Arterial spin labeling (ASL), a novel measure of cerebral blood flow
No measurements were reported for this outcome.
Collected over AEs were reported monthly over the 24-week period that each participant was on study or when taken off study if he/she did not complete the trial. Participants who completed the trial were followed up to 4 weeks after taking the last dose of the investigational product. Participants who stopped the intervention early remained on study for continued follow-up, to the extent possible, through study visits, telephone communication, and medical record review for intent-to-treat analysis.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin, Intranasal | 0/10 (0%) | 2/10 (20%) | 10/10 (100%) |
| Placebo, Intranasal | 0/11 (0%) | 2/11 (18.2%) | 11/11 (100%) |
| Event | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Major depressive episodePsychiatric disorders | 0/10 | 2/11 |
| Kidney obstructionRenal and urinary disorders | 1/10 | 0/11 |
| Cardiac eventCardiac disorders | 1/10 | 0/11 |
| Hospitalization for syncope/hypotensionVascular disorders | 1/10 | 0/11 |
| Event | Insulin, Intranasal | Placebo, Intranasal |
|---|---|---|
| Nasal Irritation or Reaction (during administration of investigational product)General disorders | 7/10 | 4/11 |
| Odor/Taste (during administration of investigational product)Product Issues | 5/10 | 1/11 |
| HeadacheNervous system disorders | 3/10 | 5/11 |
| Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 2/10 | 5/11 |
| Congestion/Runny NoseGeneral disorders | 4/10 | 3/11 |
| RashSkin and subcutaneous tissue disorders | 3/10 | 1/11 |
| NauseaGeneral disorders | 3/10 | 0/11 |
| DiarrheaGastrointestinal disorders | 0/10 | 3/11 |
| Accidental InjuryInjury, poisoning and procedural complications | 2/10 | 1/11 |
| Upper Gastrointestinal Pain or DiscomfortGastrointestinal disorders | 2/10 | 0/11 |
| Age, Continuous(years) | Insulin, Intranasal | Placebo, Intranasal | Total |
|---|---|---|---|
| Enrolled | 58.5 (55 to 61) | 58 (56 to 62) | 58 (56 to 61) |
| Completed Trial (ITT) | 57 (54.5 to 61.5) | 58 (56 to 62) | 57.5 (55 to 62.25) |
| Completed Trial (Per Protocol) | 56 (54.25 to 57.75) | 57.5 (55.75 to 59.25) | 57 (55 to 59.5) |
| Age, Customized(Participants) | Insulin, Intranasal | Placebo, Intranasal | Total |
|---|---|---|---|
| Enrolled — 30-39 | 1 | 0 | 1 |
| Enrolled — 40-49 | 0 | 1 | 1 |
| Enrolled — 50-59 | 5 | 5 | 10 |
| Enrolled — 60-69 | 4 | 5 | 9 |
| Completed Trial (ITT) — 30-39 | 1 | 0 | 1 |
| Completed Trial (ITT) — 40-49 | 0 | 1 | 1 |
| Completed Trial (ITT) — 50-59 | 4 | 5 | 9 |
| Completed Trial (ITT) — 60-69 | 2 | 3 | 5 |
| Completed Trial (Per Protocol) — 30-39 | 1 | 0 | 1 |
| Completed Trial (Per Protocol) — 40-49 | 0 | 1 | 1 |
| Completed Trial (Per Protocol) — 50-59 | 4 | 5 | 9 |
| Completed Trial (Per Protocol) — 60-69 | 1 | 2 | 3 |
| Sex: Female, Male(Participants) | Insulin, Intranasal | Placebo, Intranasal | Total |
|---|---|---|---|
| Enrolled — Female | 3 | 5 | 8 |
| Enrolled — Male | 7 | 6 | 13 |
| Completed Trial (ITT) — Female | 3 | 4 | 7 |
| Completed Trial (ITT) — Male | 4 | 5 | 9 |
| Completed Trial (Per Protocol) — Female | 3 | 3 | 6 |
| Completed Trial (Per Protocol) — Male | 3 | 5 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Insulin, Intranasal | Placebo, Intranasal | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 11 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Insulin, Intranasal | Placebo, Intranasal | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 10 | 20 |
| White | 0 | 1 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Insulin, Intranasal | Placebo, Intranasal | Total |
|---|---|---|---|
| United States | 10 | 11 | 21 |
| Education, Continuous(years) | Insulin, Intranasal | Placebo, Intranasal | Total |
|---|---|---|---|
| Enrolled | 12.70 ± 2.06 | 12.09 ± 1.87 | 12.38 ± 1.94 |
| Completed Trial (ITT) | 12.86 ± 2.34 | 12.33 ± 1.94 | 12.56 ± 2.06 |
| Completed Trial (Per Protocol) | 12.33 ± 2.07 | 12.50 ± 2.00 | 12.43 ± 1.95 |
| Education, Categorical(Participants) | Insulin, Intranasal | Placebo, Intranasal | Total |
|---|---|---|---|
| Enrolled — 9th to 11th Grade | 2 | 3 | 5 |
| Enrolled — High School Diploma | 4 | 6 | 10 |
| Enrolled — Some College or Associates Degree | 3 | 1 | 4 |
| Enrolled — College Degree | 1 | 1 | 2 |
| Completed Trial (ITT) — 9th to 11th Grade | 1 | 2 | 3 |
| Completed Trial (ITT) — High School Diploma | 3 | 5 | 8 |
| Completed Trial (ITT) — Some College or Associates Degree | 2 | 1 | 3 |
| Completed Trial (ITT) — College Degree | 1 | 1 | 2 |
| Completed Trial (Per Protocol) — 9th to 11th Grade | 1 | 1 | 2 |
| Completed Trial (Per Protocol) — High School Diploma | 3 | 5 | 8 |
| Completed Trial (Per Protocol) — Some College or Associates Degree | 2 | 1 | 3 |
| Completed Trial (Per Protocol) — College Degree | 0 | 1 | 1 |
21 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin, Regular