Investigation of the Safety of Intranasal Glulisine in Down Syndrome

NCT ID: NCT02432716

Last Updated: 2019-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2018-10-18

Brief Summary

This study is a single center, randomized, double-blind, placebo-controlled, cross-over pilot study designed to assess the safety of intranasally (IN) delivered glulisine versus placebo in patients with DS. Subjects will be randomized into this cross-over study and within subject comparisons conducted between single treatment of intranasal insulin glulisine and single treatment of intranasal placebo. All subjects will also receive a single treatment of placebo prior to randomization to ensure adherence to study procedures.

Conditions

Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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 received one dose of placebo, Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril).

Group Type: EXPERIMENTAL

Insulin glulisine

Intervention Type: DRUG

Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study

Saline

Intervention Type: DRUG

Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study

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 received one dose of Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril).

Group Type: EXPERIMENTAL

Insulin glulisine

Intervention Type: DRUG

Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study

Saline

Intervention Type: DRUG

Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study

Interventions

Insulin glulisine

Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study

Intervention Type: DRUG

Saline

Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study

Intervention Type: DRUG

Other Intervention Names

insulin, glulisine, Apidra; Placebo

Eligibility Criteria

Inclusion Criteria

• Male or female aged 35-80 years with a Down syndrome diagnosis that is confirmed by karyotype.
• Vital signs must be within normal limits for their age. (Medically treated hypertension will be allowed).
• Must have an electrocardiogram free of clinically significant findings.
• Must have an authorized representative to provide written informed consent.
• Level of speech and comprehension of verbal commands are sufficient to understand and to answer simple requests.
• Must have a reliable caregiver or family member who agrees to accompany the subject to all visits, provide information about the subject as required by this protocol.
• Must be independent for activities of daily living.
• Must tolerate the initial IN treatment of placebo and adhere to study procedures.

Exclusion Criteria

• Any current psychiatric or neurologic diagnosis other than Down syndrome or Down syndrome with dementia that is judged to impact cognition.
• Subjects who currently meet or have within the past five years met DSM-IV (Diagnostic and Statistical Manual) criteria for drug or alcohol abuse or dependence.
• Subjects residing in a skilled nursing facility or subjects who are anticipated to enter a nursing home within the next 6 months. (Subjects may reside in group homes, assisted living, or other residential settings where they do not require 24 hour skilled nursing.)
• Subjects receiving any experimental drug for Down syndrome within the past 30 days of screening visit.
• Subjects with significant allergies to or other significant intolerance insulin.
• Presence of active seizure disorder.
• Presence of significant aggression or agitation that may impact participation with testing and IN administration. All subjects must have NPI-C aggression and agitation subscore ≤ 4 (severity ≤ 2; frequency ≤ 2).
• Significant cerebrovascular disease with Modified Hachinski Score>4.
• Subjects who may not be able to comply with the protocol or perform the outcomes measures due to significant hearing or visual impairment or other issues judged relevant by the investigators.
• Subject has been diagnosed with any form of diabetes mellitus, actively takes insulin, or has HbA1c > 6.1% at screening.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H Rosenbloom, MD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Countries

United States

References

Rosenbloom M, Barclay T, Johnsen J, Erickson L, Svitak A, Pyle M, Frey W, Hanson LR. Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome. Drugs R D. 2020 Mar;20(1):11-15. doi: 10.1007/s40268-020-00296-2.

Reference Type: DERIVED

PMID: 32077057 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HealthPartnersRF

Identifier Type: -

Identifier Source: org_study_id