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
Results First Received: January 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Interventions: Drug: Formoterol
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy subjects and Type 1 Diabetics were recruited to participate in the study. Subjects in either arm were randomized to receive a placebo or the study drug: Formoterol in either the first or second visit.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control: Placebo Healthy volunteers that received Placebo first, the Formoterol.
Control: Formoterol Healthy volunteers that received Formoterol first, then Placebo.
Type 1 Diabetics: Placebo Type 1 Diabetics that received Placebo first, then Formoterol.
Type 1 Diabetics: Formoterol Type 1 Diabetics that received Formoterol first, then Placebo.

Participant Flow:   Overall Study
    Control: Placebo     Control: Formoterol     Type 1 Diabetics: Placebo     Type 1 Diabetics: Formoterol  
STARTED     3     4     2     5  
Cross-over at Second Visit     3     4     2     5  
COMPLETED     3     4     2     5  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Healthy Volunteers

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

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

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

Type 1 Diabetics

The active group were participants with type 1 diabetes.

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

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

Total Total of all reporting groups

Baseline Measures
    Healthy Volunteers     Type 1 Diabetics     Total  
Number of Participants  
[units: participants]
  7     7     14  
Age  
[units: years]
Mean (Standard Deviation)
  36  (8)     31  (11)     33.2  (9.7)  
Gender  
[units: participants]
     
Female     4     4     8  
Male     3     3     6  
Body Mass Index (BMI, kg/m^2)  
[units: kg/m^2]
Mean (Standard Deviation)
  23.7  (2.1)     25.8  (2.9)     24.8  (2.7)  
Weight (kg)  
[units: kg]
Mean (Standard Deviation)
  70.0  (12.9)     70.2  (10.6)     70.1  (11.3)  
HbA1c (%)  
[units: %]
Mean (Standard Deviation)
  5.3  (2.6)     6.8  (2.6)     6.1  (1.0)  
HbA1c (mmol/mol)  
[units: mmol/mol]
Mean (Standard Deviation)
  34.5  (2.6)     51.3  (8.5)     43.5  (10.7)  



  Outcome Measures
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1.  Primary:   Glucagon (pg/mL)   [ Time Frame: up to 120 minutes ]

2.  Primary:   Epinephrine (pg/mL)   [ Time Frame: up to 120 minutes ]

3.  Primary:   Norepinephrine (pg/mL)   [ Time Frame: up to 120 minutes ]

4.  Secondary:   Blood Glucose Levels (Average)   [ Time Frame: Up to 120 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert Sherwin, MD
Organization: Department of Internal Medicine and Endocrinology, Yale University School of Medicine, New Haven, CT
phone: (203) 785-3482
e-mail: robert.sherwin@yale.edu


Publications of Results:

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