IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase

NCT04028960 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: A16-716
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how Humulin-R regular insulin affects the body's ability to feel low blood sugar (hypoglycemia) when delivered intranasally compared to placebo in subjects with Type 1 Diabetes (T1D) with hypoglycemia awareness. The study will use continuous glucose monitoring (CGM) to collect this information. The study drug or placebo will be administered using an intranasal device.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

• Percentage of Time With Dangerous Hypoglycemia

  Defined using percent time below range (\<54 mg/dL), from real-time continuous glucose monitoring (CGM)

  Two 14-20 day treatment periods

Secondary Outcomes (8)

• Percent of Time With Blood Glucose 70-180 mg/dL

  Two 14-20 day treatment periods

• Percentage of Time With Blood Glucose <70 mg/dL

  Two 14-20 day treatment periods

• Percentage of Time Blood Glucose >180 mg/dL

  Two 14-20 day treatment periods

• Percentage of Time With Blood Glucose >250 mg/dL

  Two 14-20 day treatment periods

• Percentage of Time Participant Had Active Sensor Wear

  Two 14-20 day treatment periods

Study Arms (2)

Placebo

PLACEBO COMPARATOR

No active drug

Device: SipNose intranasal device

Humulin-R

EXPERIMENTAL

Insulin

Drug: Regular insulin (Humulin-R), intranasal route; Device: SipNose intranasal device

Interventions

Regular insulin (Humulin-R), intranasal route DRUG

Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes.

Humulin-R

SipNose intranasal device DEVICE

The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain.

Humulin-R; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age ≥18) with type 1 diabetes diagnosis and a duration of diabetes of at least 10 years
• Gold score \<4
• HbA1c ≥6.5% within the last 3 months or at screen visit
• Stable insulin regimen (MDI or insulin pump) for at least 3 months, as deemed stable by principal investigator
• Depression/anxiety medications stable for at least 3 months
• Ability and willingness to wear CGM continuously during study participation
• Participants must use their own smartphone, and have the ability and willingness to use CGM smartphone applications compatible with their smartphone
• Ability and willingness to check self-monitoring of blood glucose (SMBG) using own supplies, as instructed by study staff
• Ability and willingness to document when having symptoms of hypoglycemia in the CGM smartphone app or in a diary
• Willing to operate insulin pump without threshold suspend feature or hybrid closed-loop, if applicable
• Proficient in speaking, reading and understanding English in order to complete surveys and testing of cognitive function
• Women of child-bearing age must agree to procure and use contraception throughout the study

You may not qualify if:

• Pregnancy or planning pregnancy
• eGFR ≤ 30 mL/min per 1.73 m2, if available from medical record
• Completed any other research study within 6 months of screening date
• Current or recent use within 3 months of an insulin delivery system that adjusts insulin in response to continuous glucose monitoring (CGM) data (such as an automated insulin delivery system like hybrid closed-loop insulin pump therapy)
• Known dementia or mild cognitive impairment diagnosis
• Diabetic ketoacidosis within the last 6 months
• Use of non-insulin medications to treat diabetes
• Those planning to change diet or exercise regimen during the study
• History of trans-sphenoidal surgery or surgery to the upper part of the nasal cavity, chronic sinusitis, severe deviated septum, or difficulty with smell and/or taste
• Severe psychiatric illness
• Allergy to adhesives, insulin or any components of insulin product
• Subject cannot adequately demonstrate ability to use and deploy the devices as determined by investigator
• Evidence of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Sponsors & Collaborators

• HealthPartners Institute: lead
• International Diabetes Center at Park Nicollet: collaborator
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Health Partners Institute dba International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The study team was unable to draw conclusions at this time regarding the cognitive testing performed due to abbreviated funding which led to a small number of subjects analyzed.

Results Point of Contact

• Title: Anders Carlson, MD
• Organization: HealthPartners Institute dba International Diabetes Center

Anders.L.Carlson@HealthPartners.Com

952-993-1927

Study Officials

• Anders L Carlson, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: October 23, 2019
• Primary Completion: April 8, 2020
• Study Completion: April 8, 2020
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2020-05

Locations

US (1)