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

September 1, 2010
February 26, 2016
August 2010
August 2014   (final data collection date for primary outcome measure)
  • 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
Hormone Levels [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
Glucagon and catecholamine 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.
Complete list of historical versions of study NCT01194479 on ClinicalTrials.gov Archive Site
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.
Blood glucose levels [ Time Frame: 5 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.
Not Provided
Not Provided
 
Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.
The Effect of the Beta 2 Agonist, Formoterol, on Recovery From Hypoglycemia
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.
  • Active Comparator: Type 1 Diabetics
    The active group were participants with type 1 diabetes.
    Interventions:
    • Drug: Formoterol
    • Other: Placebo
  • Healthy Volunteers
    The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.
    Interventions:
    • Drug: Formoterol
    • Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01194479
HIC1005006832, R37-20495
No
Not Provided
Not Provided
Yale University
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Robert Sherwin, MD Yale School of Medicine
Yale University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP