Trial Outcomes & Findings for Investigation of the Safety of Intranasal Glulisine in Down Syndrome (NCT NCT02432716)

NCT ID: NCT02432716

Last Updated: 2019-12-06

Results Overview

Number of adverse and/or serious events

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

1 year

Results posted on

2019-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Insulin (Glulisine), Then Placebo Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After a washout period of 2 weeks, they then receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intranasal in each nostril).	Placebo, Then Insulin (Glulisine) Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After a washout period of 2 weeks, they then receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril).
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigation of the Safety of Intranasal Glulisine in Down Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 Participants Participants first receive either one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril) or placebo, Sterile Normal Saline 20 IU/IN (.1ml intranasal in each nostril). After a washout period of 2 weeks, they then receive the opposite. Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
Age, Continuous	42.7 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
A1C	5.4 mmol/mol STANDARD_DEVIATION 0.1 • n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Number of adverse and/or serious events

Outcome measures

Outcome measures
Measure	Insulin (Glulisine), Then Placebo n=6 Participants Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After a washout period of 2 weeks, they then receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intranasal in each nostril). Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study	Placebo, Then Insulin (Glulisine) n=6 Participants Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After a washout period of 2 weeks, they then receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
Safety Measured by Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Insulin (Glulisine), Then Placebo n=12 Participants Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After a washout period of 2 weeks, they then receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intranasal in each nostril). Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study	Placebo, Then Insulin (Glulisine) n=12 Participants Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After a washout period of 2 weeks, they then receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) Learning Curve	2.3 score on a scale Standard Error .5	2.0 score on a scale Standard Error .6
Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) Total Immediate Recall	33.8 score on a scale Standard Error 3.5	36.8 score on a scale Standard Error 3.3
Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) Total Delayed Recall	6.1 score on a scale Standard Error .6	6.4 score on a scale Standard Error .8
Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) Recognition Memory	2.3 score on a scale Standard Error .3	1.9 score on a scale Standard Error .5
Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME) Retention Estimate	8.3 score on a scale Standard Error .4	8.3 score on a scale Standard Error .6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Insulin (Glulisine), Then Placebo n=12 Participants Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After a washout period of 2 weeks, they then receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intranasal in each nostril). Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study	Placebo, Then Insulin (Glulisine) n=12 Participants Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After a washout period of 2 weeks, they then receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
Memory Retention Measured by Fuld Object-Memory Evaluation (FOME)	72.3 percentage of items correctly identified Standard Error 5.3	68.7 percentage of items correctly identified Standard Error 6.5

SECONDARY outcome

Timeframe: 20 minutes

Population: Rivermead Memory Retention is missing for one subject at post-saline time.

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

Outcome measures

Outcome measures
Measure	Insulin (Glulisine), Then Placebo n=12 Participants Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After a washout period of 2 weeks, they then receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intranasal in each nostril). Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study	Placebo, Then Insulin (Glulisine) n=12 Participants Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After a washout period of 2 weeks, they then receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
Cognitive Change Measured by Rivermead Behavioral Memory Test (RBMT-C) Immediate Recall	6.6 score on a scale Standard Error 1.4	5.4 score on a scale Standard Error 1.2
Cognitive Change Measured by Rivermead Behavioral Memory Test (RBMT-C) Delayed Recall	6.6 score on a scale Standard Error 1.5	7.2 score on a scale Standard Error 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Insulin (Glulisine), Then Placebo n=12 Participants Participants first receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). After a washout period of 2 weeks, they then receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intranasal in each nostril). Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study	Placebo, Then Insulin (Glulisine) n=12 Participants Participants first receive one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril). After a washout period of 2 weeks, they then receive one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril). Insulin glulisine: Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study Saline: Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
Memory Retention Measured by Rivermead Behavioral Memory Test (RBMT-C).	9.7 percentage of story elements recalled Standard Error 1.3	16.9 percentage of story elements recalled Standard Error 3.8

Adverse Events

Post-Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post-Insulin (Glulisine)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trial Manager

HealthPartners Neuroscience Research

Phone: 651-495-6363

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place