Trial · NCT02432716
Investigation of the Safety of Intranasal Glulisine in Down Syndrome
NCT02432716, Phase 1, Completed, HealthPartners Institute; results first posted 2019-12-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigation of the Safety of Intranasal Glulisine in Down Syndrome. Trials, record NCT02432716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02432716
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigation of the Safety of Intranasal Glulisine in Down Syndrome
- NCT number
- NCT02432716
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- HealthPartners Institute
- Conditions
- Down Syndrome
- Interventions
- Insulin glulisine, Saline
- First posted
- 2015-05-04
- Last updated
- 2019-12-06
- Results first posted
- 2019-12-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Measured by Adverse Events | 1 year | Number of adverse and/or serious events |
| Secondary | Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) | 20 minutes | During the examination, a patient is presented with ten common objects they are asked to identify by touch. The test uses distraction to test recall. For all, a higher score indicates a better outcome. * Learning curve is the number of objects the difference in the number of items they are able to correctly identify from the greater of trials 4 or 5 compared to trial 1. Range: 0-10 * Total immediate recall is the number of objects recalled over all of the trials. Range: 0-50 * Total delayed recall is the number of objects recalled after 5 minutes. Range: 0-10 * Recognition memory is the number of items correct from a multiple choice list of three when unable to correctly identify items from delayed recall. Range: 0-10 * Retention estimate is the number of items recalled after 5 minutes or being reminded with multiple choice. Range: 0-10 |
| Secondary | Memory Retention Measured by Fuld Object-Memory Evaluation (FOME) | 20 minutes | Memory retention is the percentage of items correctly identify during the delayed recall trial compared storage trial 5. Range: 0-100 percent. A higher percentage indicates a better outcome. |
| Secondary | Cognitive Change Measured by Rivermead Behavioral Memory Test (RBMT-C) | 20 minutes | The RBMT-C provides an objective measure of everyday memory problems reported and observed in subjects with memory difficulties. The test is standardized for use with children ranging in age from 5 to 10 years. Here, we used it for evaluation of Down Syndrome subjects. The story recall subtests involves immediate free recall, cued recall, and delayed recall of short story material which is presented orally to subjects by the examiner. The RBMT-C is appealing for use in this population because the task is engaging, simple, and has been shown in other studies to be an effective measure of memory functions. For all, a higher score means a better outcome. * Immediate Recall is the number of story elements recalled right after the story is complete. Range: 0-31 * Delayed Recall is the number of story elements recalled after a delay. Range: 0-31 |
| Secondary | Memory Retention Measured by Rivermead Behavioral Memory Test (RBMT-C). | 20 minutes | The RBMT-C provides an objective measure of everyday memory problems reported and observed in subjects with memory difficulties. The test is standardized for use with children ranging in age from 5 to 10 years. Here, we used it for evaluation of Down Syndrome subjects. The story recall subtests involves immediate free recall, cued recall, and delayed recall of short story material which is presented orally to subjects by the examiner. The RBMT-C is appealing for use in this population because the task is engaging, simple, and has been shown in other studies to be an effective measure of memory functions. Memory retention is the percentage of story elements recalled after a delay compared to right after the story is complete. Range: 0-100. A higher score means a better outcome. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety Measured by Adverse Events | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) | 20 minutes | score on a scale | MEAN | |
| SECONDARY | Memory Retention Measured by Fuld Object-Memory Evaluation (FOME) | 20 minutes | percentage of items correctly identified | MEAN | |
| SECONDARY | Cognitive Change Measured by Rivermead Behavioral Memory Test (RBMT-C) | 20 minutes | Rivermead Memory Retention is missing for one subject at post-saline time. | score on a scale | MEAN |
| SECONDARY | Memory Retention Measured by Rivermead Behavioral Memory Test (RBMT-C). | 20 minutes | percentage of story elements recalled | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Measured by Adverse Events | Insulin (Glulisine), Then Placebo | 0 | Participants | ||
| Safety Measured by Adverse Events | Placebo, Then Insulin (Glulisine) | 0 | Participants | ||
| Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) | Post- Placebo | Learning Curve | 2.3 | Standard Error .5 | score on a scale |
| Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) | Post-Insulin (Glulisine) | Learning Curve | 2.0 | Standard Error .6 | score on a scale |
| Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) | Post- Placebo | Total Immediate Recall | 33.8 | Standard Error 3.5 | score on a scale |
| Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) | Post-Insulin (Glulisine) | Total Immediate Recall | 36.8 | Standard Error 3.3 | score on a scale |
| Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) | Post- Placebo | Total Delayed Recall | 6.1 | Standard Error .6 | score on a scale |
| Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) | Post-Insulin (Glulisine) | Total Delayed Recall | 6.4 | Standard Error .8 | score on a scale |
| Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) | Post- Placebo | Recognition Memory | 2.3 | Standard Error .3 | score on a scale |
| Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) | Post-Insulin (Glulisine) | Recognition Memory | 1.9 | Standard Error .5 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Insulin (Glulisine), Then Placebo | 6 | |
| Overall Study | STARTED | Placebo, Then Insulin (Glulisine) | 6 | |
| Overall Study | COMPLETED | Insulin (Glulisine), Then Placebo | 6 | |
| Overall Study | COMPLETED | Placebo, Then Insulin (Glulisine) | 6 | |
| Overall Study | NOT COMPLETED | Insulin (Glulisine), Then Placebo | 0 | |
| Overall Study | NOT COMPLETED | Placebo, Then Insulin (Glulisine) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Post-Placebo | 0 | 12 |
| Total, all-cause mortality | Post-Insulin (Glulisine) | 0 | 12 |
| Total, other adverse events | Post-Placebo | 0 | 12 |
| Total, other adverse events | Post-Insulin (Glulisine) | 0 | 12 |
| Total, serious adverse events | Post-Placebo | 0 | 12 |
| Total, serious adverse events | Post-Insulin (Glulisine) | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32077057 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Post-Insulin (Glulisine) vs Post-Placebo: deaths from any cause | Trial comparisons |
| Insulin (Glulisine), Then Placebo vs Placebo, Then Insulin (Glulisine): Safety Measured by Adverse Events | Trial comparisons |
| Post-Insulin (Glulisine) vs Post-Placebo: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Short Story Recall | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02432716
GET https://conductscience.org/api/trials/v1/NCT02432716/registered