Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01194479
First received: September 1, 2010
Last updated: February 26, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Type 1 Diabetes
Drug: Formoterol
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of the Beta 2 Agonist, Formoterol, on Recovery From Hypoglycemia

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Glucagon (pg/mL) [ Time Frame: up to 120 minutes ] [ Designated as safety issue: No ]
    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.

  • Epinephrine (pg/mL) [ Time Frame: up to 120 minutes ] [ Designated as safety issue: No ]
    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

  • Norepinephrine (pg/mL) [ Time Frame: up to 120 minutes ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Blood Glucose Levels (Average) [ Time Frame: Up to 120 minutes ] [ Designated as safety issue: Yes ]
    Blood glucose levels will be checked every 5 minutes during the 120 minute study session in order to maintain blood glucose levels in the normal and hypoglycemic range. Presented is the average of the collected values.


Enrollment: 14
Study Start Date: August 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Type 1 Diabetics
The active group were participants with type 1 diabetes.
Drug: Formoterol
Formoterol inhaler, 12mcg capsules, 4 capsules for one administration
Other Name: Foradil Aerolizer
Other: Placebo
Participants in both arms received placebo on 1 of the 2 visits.
Healthy Volunteers
The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.
Drug: Formoterol
Formoterol inhaler, 12mcg capsules, 4 capsules for one administration
Other Name: Foradil Aerolizer
Other: Placebo
Participants in both arms received placebo on 1 of the 2 visits.

Detailed Description:

Note: Below is the original detailed description submitted in 2010. The recruitment for this study was stopped at 7 subjects in each study arm. The study design and outcome measures did not change for this study. See below for further details.

Original: 15 subjects with well controlled type 1 diabetes and regular hypoglycemia and 15 healthy volunteers will be recruited for this study.

If you agree to participate in this study, you will be asked to participate in a screening at Yale New Haven Hospital. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, the subject will be given an inhaler. On one visit the inhaler will contain formoterol capsules and on the other visit, the subject will be given 'dummy' capsules. Subjects will be required to be admitted to the HRU the night before the study so that glucose levels can be stabilized and hypoglycemia avoided.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • significant diabetes complications
  • liver disease, cirrhosis
  • cardiac disease
  • neurological disorder
  • autonomic neuropathy
  • kidney disease
  • lactose intolerance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194479

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Robert Sherwin, MD Yale School of Medicine
  More Information

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01194479     History of Changes
Other Study ID Numbers: HIC1005006832  R37-20495 
Study First Received: September 1, 2010
Results First Received: January 28, 2016
Last Updated: February 26, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
type 1 diabetes
hypoglycemia
formoterol

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2016