N/A N=14 Randomized Double-blind Treatment

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

Type 1 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT01194479 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Glucagon (pg/mL) — 76; 74; 53; 56 pg/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Formoterol (Drug); Placebo (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Glucagon (pg/mL)	76; 74; 53; 56; 59; 58	—
PRIMARY Epinephrine (pg/mL)	15; 16; 18; 17; 12; 12	—
PRIMARY Norepinephrine (pg/mL)	185; 192; 180; 133; 216; 273	—
SECONDARY Blood Glucose Levels (Average)	57.38; 58.39; 53.21; 55.43	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01194479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.