NCT02131948

Brief Summary

It is well known that the hormone insulin lowers blood glucose in part by acting directly on the liver and reducing hepatic glucose production. Animal studies have shown that the hormone insulin can act on the brain to indirectly lower glucose production by the liver. We aim to test whether this is true in humans by giving insulin intranasally. It has previously been shown that a nasal spray can deliver insulin directly to the brain without affecting circulating insulin concentration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

May 2, 2014

Last Update Submit

November 30, 2015

Conditions

Insulin Resistance, Diabetes

Keywords

Insulin resistanceBrain insulin actionType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Endogenous glucose production

    Effects of intranasal insulin and placebo on endogenous glucose production will be assessed

    8 hours

Study Arms (2)

Intranasal insulin

EXPERIMENTAL

40 IU of intranasal insulin

Drug: Intranasal insulin

Intranasal placebo

PLACEBO COMPARATOR

Placebo comparator to intranasal insulin

Drug: Intranasal placebo

Interventions

Intranasal insulinDRUG

Intranasal spray

Also known as: Humalog lispro 40 IU intranasally
Intranasal insulin
Intranasal placeboDRUG

Intranasal spray

Also known as: Diluent intranasally
Intranasal placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women, aged 18 to 60 years
  • Body mass index 20-27.
  • Hemoglobin in the normal range.
  • Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test
  • Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study.
  • Volunteers who have taken part in the study with the previously approved protocol will be eligible to participate in the amended study, if they provide their informed consent

You may not qualify if:

  • Study participant with a history of hepatitis/hepatic disease that has been active within the previous two years.
  • \. Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
  • \. Any current or previous history of endocrine disease, dyslipidemia or malignancy 4. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr \> 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic BP \> 100 or systolic \> 180 or systolic BP\<100) or proliferative retinopathy 5. Use of immunosuppressive agents at any time during the study 6. Allergy to any study medication 7. Pregnancy or breastfeeding 8. Heavy smoker 9. Prior nasoduodenal tube insertion under fluoroscopic guidance. 10. Fasting blood glucose \> 6.0 mmol/l or known diabetes. 11. Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
  • \. Any nasal pathology likely to affect absorption of insulin or insertion of nasoduodenal tube.
  • \. Any laboratory values: AST \> 2x ULN; ALT \> 2x ULN TSH \> 6 mU/l 14. Current addiction to alcohol or substances of abuse as determined by the investigator.
  • \. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation 16. Taking any regular prescription or non-prescription medications at the time of the study. Occasional use of medications such as acetoaminophen or Tylenol 1 or any use of natural health products may be permitted at the discretion of the investigator.
  • \. Will not donate blood three months prior to and three months post study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tornto General Hospital, UHN

Toronto, Ontario, M5G 1L7, Canada

Location

MeSH Terms

Conditions

Insulin ResistanceDiabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2014

First Posted

May 6, 2014

Study Start

November 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

CA(1)