Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01194479
Recruitment Status : Completed
First Posted : September 3, 2010
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Drug: Formoterol
Other: Placebo
Enrollment 14
Recruitment Details 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  
Arm/Group Title Control: Placebo Control: Formoterol Type 1 Diabetics: Placebo Type 1 Diabetics: Formoterol
Hide Arm/Group Description Healthy volunteers that received Placebo first, the Formoterol. Healthy volunteers that received Formoterol first, then Placebo. Type 1 Diabetics that received Placebo first, then Formoterol. Type 1 Diabetics that received Formoterol first, then Placebo.
Period Title: Overall Study
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
Arm/Group Title Healthy Volunteers Type 1 Diabetics Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 14 participants
36  (8) 31  (11) 33.2  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
Female
4
  57.1%
4
  57.1%
8
  57.1%
Male
3
  42.9%
3
  42.9%
6
  42.9%
Body Mass Index (BMI, kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 7 participants 7 participants 14 participants
23.7  (2.1) 25.8  (2.9) 24.8  (2.7)
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 7 participants 7 participants 14 participants
70.0  (12.9) 70.2  (10.6) 70.1  (11.3)
HbA1c (%)  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 7 participants 7 participants 14 participants
5.3  (2.6) 6.8  (2.6) 6.1  (1.0)
HbA1c (mmol/mol)  
Mean (Standard Deviation)
Unit of measure:  Mmol/mol
Number Analyzed 7 participants 7 participants 14 participants
34.5  (2.6) 51.3  (8.5) 43.5  (10.7)
1.Primary Outcome
Title Glucagon (pg/mL)
Hide Description 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.
Time Frame up to 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Results are pooled at the arm level and split by placebo and control regardless of randomization order.
Arm/Group Title Control: Placebo Control: Formoterol Type 1 Diabetics: Placebo Type 1 Diabetics: Formoterol
Hide Arm/Group Description:
Healthy volunteers that received Placebo on the first or second visit.
Healthy volunteers that received Formoterol on the first or second visit.
Type 1 Diabetics that received placebo on the first or second visit.
Type 1 Diabetics that received Formoterol on the first or second visit.
Overall Number of Participants Analyzed 7 7 7 7
Mean (Standard Error)
Unit of Measure: pg/mL
Basal 76  (13) 74  (11) 53  (8) 56  (10)
Euglycemia 59  (11) 58  (13) 55  (10) 54  (9)
Hypoglycemia 66  (16) 73  (18) 43  (8) 46  (9)
2.Primary Outcome
Title Epinephrine (pg/mL)
Hide Description 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
Time Frame up to 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Results are pooled at the arm level and split by placebo and control regardless of randomization order.
Arm/Group Title Control: Placebo Control: Formoterol Type 1 Diabetics: Placebo Type 1 Diabetics: Formoterol
Hide Arm/Group Description:
Healthy volunteers that received Placebo on the first or second visit.
Healthy volunteers that received Formoterol on the first or second visit.
Type 1 Diabetics that received placebo on the first or second visit.
Type 1 Diabetics that received Formoterol on the first or second visit.
Overall Number of Participants Analyzed 7 7 7 7
Mean (Standard Error)
Unit of Measure: pg/mL
Basal 15  (4) 16  (5) 18  (4) 17  (5)
Euglycemia 12  (3) 12  (4) 21  (5) 13  (2)
Hypoglycemia 46  (15) 55  (22) 44  (15) 19  (4)
3.Primary Outcome
Title Norepinephrine (pg/mL)
Hide Description 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
Time Frame up to 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Results are pooled at the arm level and split by placebo and control regardless of randomization order.
Arm/Group Title Control: Placebo Control: Formoterol Type 1 Diabetics: Placebo Type 1 Diabetics: Formoterol
Hide Arm/Group Description:
Healthy volunteers that received Placebo on the first or second visit.
Healthy volunteers that received Formoterol on the first or second visit.
Type 1 Diabetics that received placebo on the first or second visit.
Type 1 Diabetics that received Formoterol on the first or second visit.
Overall Number of Participants Analyzed 7 7 7 7
Mean (Standard Error)
Unit of Measure: pg/mL
Basal 185  (37) 192  (24) 180  (28) 133  (13)
Euglycemia 216  (31) 273  (22) 226  (31) 211  (30)
Hypoglycemia 156  (21) 181  (14) 241  (30) 190  (32)
4.Secondary Outcome
Title Blood Glucose Levels (Average)
Hide Description 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.
Time Frame Up to 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects are pooled across randomized conditions in their respective study arms and reported overall.
Arm/Group Title Control: Placebo Control: Formoterol Type 1 Diabetics: Placebo Type 1 Diabetics: Formoterol
Hide Arm/Group Description:
Healthy volunteers that received Placebo on the first or second visit.
Healthy volunteers that received Formoterol on the first or second visit.
Type 1 Diabetics that received placebo on the first or second visit.
Type 1 Diabetics that received Formoterol on the first or second visit.
Overall Number of Participants Analyzed 7 7 7 7
Mean (Standard Deviation)
Unit of Measure: mg/dL
57.38  (3.45) 58.39  (2.40) 53.21  (2.57) 55.43  (4.40)
Time Frame Adverse events are reported by the study arm and randomized visit order.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control: Placebo Control: Formoterol Type 1 Diabetics: Placebo Type 1 Diabetics: Formoterol
Hide Arm/Group Description Healthy volunteers that received Placebo on the first visit. Healthy volunteers that received Formoterol on the first visit. Type 1 Diabetics that received placebo on the first visit. Type 1 Diabetics that received Formoterol on the first visit.
All-Cause Mortality
Control: Placebo Control: Formoterol Type 1 Diabetics: Placebo Type 1 Diabetics: Formoterol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control: Placebo Control: Formoterol Type 1 Diabetics: Placebo Type 1 Diabetics: Formoterol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)      0/7 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control: Placebo Control: Formoterol Type 1 Diabetics: Placebo Type 1 Diabetics: Formoterol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      3/7 (42.86%)      0/7 (0.00%)      2/7 (28.57%)    
Cardiac disorders         
Mild Palpitations   0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
General disorders         
Shakiness   0/7 (0.00%)  0 3/7 (42.86%)  3 0/7 (0.00%)  0 1/7 (14.29%)  1
Hunger   1/7 (14.29%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1
Tiredness   1/7 (14.29%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1
Nervous system disorders         
Light Headedness   0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
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
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01194479     History of Changes
Other Study ID Numbers: HIC1005006832
R37-20495 ( Other Grant/Funding Number: NIDDK )
First Submitted: September 1, 2010
First Posted: September 3, 2010
Results First Submitted: January 28, 2016
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016