NCT01194479

Brief Summary

Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). The aim of this study is to determine whether a formoterol inhaler can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 29, 2016

Completed
Last Updated

March 29, 2016

Status Verified

February 1, 2016

Enrollment Period

4 years

First QC Date

September 1, 2010

Results QC Date

January 28, 2016

Last Update Submit

February 26, 2016

Conditions

Type 1 Diabetes

Keywords

type 1 diabeteshypoglycemiaformoterol

Outcome Measures

Primary Outcomes (3)

  • Glucagon (pg/mL)

    Glucagon levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages.

    up to 120 minutes

  • Epinephrine (pg/mL)

    Epinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages

    up to 120 minutes

  • Norepinephrine (pg/mL)

    Norepinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages

    up to 120 minutes

Secondary Outcomes (1)

  • Blood Glucose Levels (Average)

    Up to 120 minutes

Study Arms (2)

Type 1 Diabetics

ACTIVE COMPARATOR

The active group were participants with type 1 diabetes.

Drug: FormoterolOther: Placebo

Healthy Volunteers

OTHER

The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.

Drug: FormoterolOther: Placebo

Interventions

FormoterolDRUG

Formoterol inhaler, 12mcg capsules, 4 capsules for one administration

Also known as: Foradil Aerolizer
Healthy VolunteersType 1 Diabetics
PlaceboOTHER

Participants in both arms received placebo on 1 of the 2 visits.

Healthy VolunteersType 1 Diabetics

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk)
  • age 18-50
  • BMI 18-30

You may not qualify if:

  • pregnancy
  • significant diabetes complications
  • liver disease, cirrhosis
  • cardiac disease
  • neurological disorder
  • autonomic neuropathy
  • kidney disease
  • lactose intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • Belfort-DeAguiar RD, Naik S, Hwang J, Szepietowska B, Sherwin RS. Inhaled Formoterol Diminishes Insulin-Induced Hypoglycemia in Type 1 Diabetes. Diabetes Care. 2015 Sep;38(9):1736-41. doi: 10.2337/dc14-2472. Epub 2015 Jul 7.

    PMID: 26153273RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Results Point of Contact

Title
Robert Sherwin, MD
Organization
Department of Internal Medicine and Endocrinology, Yale University School of Medicine, New Haven, CT
robert.sherwin@yale.edu
(203) 785-3482

Study Officials

  • Robert Sherwin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 3, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 29, 2016

Results First Posted

March 29, 2016

Record last verified: 2016-02

Locations

US(1)