Trial Outcomes & Findings for Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes. (NCT NCT01194479)
NCT ID: NCT01194479
Last Updated: 2016-03-29
Results Overview
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.
COMPLETED
NA
14 participants
up to 120 minutes
2016-03-29
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
2
|
5
|
|
Overall Study
Cross-over at Second Visit
|
3
|
4
|
2
|
5
|
|
Overall Study
COMPLETED
|
3
|
4
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=7 Participants
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
n=7 Participants
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
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 8 • n=5 Participants
|
31 years
STANDARD_DEVIATION 11 • n=7 Participants
|
33.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Body Mass Index (BMI, kg/m^2)
|
23.7 kg/m^2
STANDARD_DEVIATION 2.1 • n=5 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 2.9 • n=7 Participants
|
24.8 kg/m^2
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Weight (kg)
|
70.0 kg
STANDARD_DEVIATION 12.9 • n=5 Participants
|
70.2 kg
STANDARD_DEVIATION 10.6 • n=7 Participants
|
70.1 kg
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
HbA1c (%)
|
5.3 %
STANDARD_DEVIATION 2.6 • n=5 Participants
|
6.8 %
STANDARD_DEVIATION 2.6 • n=7 Participants
|
6.1 %
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
HbA1c (mmol/mol)
|
34.5 mmol/mol
STANDARD_DEVIATION 2.6 • n=5 Participants
|
51.3 mmol/mol
STANDARD_DEVIATION 8.5 • n=7 Participants
|
43.5 mmol/mol
STANDARD_DEVIATION 10.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 120 minutesPopulation: Results are pooled at the arm level and split by placebo and control regardless of randomization order.
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.
Outcome measures
| Measure |
Control: Placebo
n=7 Participants
Healthy volunteers that received Placebo on the first or second visit.
|
Control: Formoterol
n=7 Participants
Healthy volunteers that received Formoterol on the first or second visit.
|
Type 1 Diabetics: Placebo
n=7 Participants
Type 1 Diabetics that received placebo on the first or second visit.
|
Type 1 Diabetics: Formoterol
n=7 Participants
Type 1 Diabetics that received Formoterol on the first or second visit.
|
|---|---|---|---|---|
|
Glucagon (pg/mL)
Basal
|
76 pg/mL
Standard Error 13
|
74 pg/mL
Standard Error 11
|
53 pg/mL
Standard Error 8
|
56 pg/mL
Standard Error 10
|
|
Glucagon (pg/mL)
Euglycemia
|
59 pg/mL
Standard Error 11
|
58 pg/mL
Standard Error 13
|
55 pg/mL
Standard Error 10
|
54 pg/mL
Standard Error 9
|
|
Glucagon (pg/mL)
Hypoglycemia
|
66 pg/mL
Standard Error 16
|
73 pg/mL
Standard Error 18
|
43 pg/mL
Standard Error 8
|
46 pg/mL
Standard Error 9
|
PRIMARY outcome
Timeframe: up to 120 minutesPopulation: Results are pooled at the arm level and split by placebo and control regardless of randomization order.
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
Outcome measures
| Measure |
Control: Placebo
n=7 Participants
Healthy volunteers that received Placebo on the first or second visit.
|
Control: Formoterol
n=7 Participants
Healthy volunteers that received Formoterol on the first or second visit.
|
Type 1 Diabetics: Placebo
n=7 Participants
Type 1 Diabetics that received placebo on the first or second visit.
|
Type 1 Diabetics: Formoterol
n=7 Participants
Type 1 Diabetics that received Formoterol on the first or second visit.
|
|---|---|---|---|---|
|
Epinephrine (pg/mL)
Basal
|
15 pg/mL
Standard Error 4
|
16 pg/mL
Standard Error 5
|
18 pg/mL
Standard Error 4
|
17 pg/mL
Standard Error 5
|
|
Epinephrine (pg/mL)
Hypoglycemia
|
46 pg/mL
Standard Error 15
|
55 pg/mL
Standard Error 22
|
44 pg/mL
Standard Error 15
|
19 pg/mL
Standard Error 4
|
|
Epinephrine (pg/mL)
Euglycemia
|
12 pg/mL
Standard Error 3
|
12 pg/mL
Standard Error 4
|
21 pg/mL
Standard Error 5
|
13 pg/mL
Standard Error 2
|
PRIMARY outcome
Timeframe: up to 120 minutesPopulation: Results are pooled at the arm level and split by placebo and control regardless of randomization order.
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
Outcome measures
| Measure |
Control: Placebo
n=7 Participants
Healthy volunteers that received Placebo on the first or second visit.
|
Control: Formoterol
n=7 Participants
Healthy volunteers that received Formoterol on the first or second visit.
|
Type 1 Diabetics: Placebo
n=7 Participants
Type 1 Diabetics that received placebo on the first or second visit.
|
Type 1 Diabetics: Formoterol
n=7 Participants
Type 1 Diabetics that received Formoterol on the first or second visit.
|
|---|---|---|---|---|
|
Norepinephrine (pg/mL)
Euglycemia
|
216 pg/mL
Standard Error 31
|
273 pg/mL
Standard Error 22
|
226 pg/mL
Standard Error 31
|
211 pg/mL
Standard Error 30
|
|
Norepinephrine (pg/mL)
Basal
|
185 pg/mL
Standard Error 37
|
192 pg/mL
Standard Error 24
|
180 pg/mL
Standard Error 28
|
133 pg/mL
Standard Error 13
|
|
Norepinephrine (pg/mL)
Hypoglycemia
|
156 pg/mL
Standard Error 21
|
181 pg/mL
Standard Error 14
|
241 pg/mL
Standard Error 30
|
190 pg/mL
Standard Error 32
|
SECONDARY outcome
Timeframe: Up to 120 minutesPopulation: Subjects are pooled across randomized conditions in their respective study arms and reported overall.
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.
Outcome measures
| Measure |
Control: Placebo
n=7 Participants
Healthy volunteers that received Placebo on the first or second visit.
|
Control: Formoterol
n=7 Participants
Healthy volunteers that received Formoterol on the first or second visit.
|
Type 1 Diabetics: Placebo
n=7 Participants
Type 1 Diabetics that received placebo on the first or second visit.
|
Type 1 Diabetics: Formoterol
n=7 Participants
Type 1 Diabetics that received Formoterol on the first or second visit.
|
|---|---|---|---|---|
|
Blood Glucose Levels (Average)
|
57.38 mg/dL
Standard Deviation 3.45
|
58.39 mg/dL
Standard Deviation 2.40
|
53.21 mg/dL
Standard Deviation 2.57
|
55.43 mg/dL
Standard Deviation 4.40
|
Adverse Events
Control: Placebo
Control: Formoterol
Type 1 Diabetics: Placebo
Type 1 Diabetics: Formoterol
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control: Placebo
n=7 participants at risk
Healthy volunteers that received Placebo on the first visit.
|
Control: Formoterol
n=7 participants at risk
Healthy volunteers that received Formoterol on the first visit.
|
Type 1 Diabetics: Placebo
n=7 participants at risk
Type 1 Diabetics that received placebo on the first visit.
|
Type 1 Diabetics: Formoterol
n=7 participants at risk
Type 1 Diabetics that received Formoterol on the first visit.
|
|---|---|---|---|---|
|
General disorders
Shakiness
|
0.00%
0/7 • Adverse events are reported by the study arm and randomized visit order.
|
42.9%
3/7 • Number of events 3 • Adverse events are reported by the study arm and randomized visit order.
|
0.00%
0/7 • Adverse events are reported by the study arm and randomized visit order.
|
14.3%
1/7 • Number of events 1 • Adverse events are reported by the study arm and randomized visit order.
|
|
General disorders
Hunger
|
14.3%
1/7 • Number of events 1 • Adverse events are reported by the study arm and randomized visit order.
|
14.3%
1/7 • Number of events 1 • Adverse events are reported by the study arm and randomized visit order.
|
0.00%
0/7 • Adverse events are reported by the study arm and randomized visit order.
|
14.3%
1/7 • Number of events 1 • Adverse events are reported by the study arm and randomized visit order.
|
|
General disorders
Tiredness
|
14.3%
1/7 • Number of events 1 • Adverse events are reported by the study arm and randomized visit order.
|
14.3%
1/7 • Number of events 1 • Adverse events are reported by the study arm and randomized visit order.
|
0.00%
0/7 • Adverse events are reported by the study arm and randomized visit order.
|
14.3%
1/7 • Number of events 1 • Adverse events are reported by the study arm and randomized visit order.
|
|
Cardiac disorders
Mild Palpitations
|
0.00%
0/7 • Adverse events are reported by the study arm and randomized visit order.
|
0.00%
0/7 • Adverse events are reported by the study arm and randomized visit order.
|
0.00%
0/7 • Adverse events are reported by the study arm and randomized visit order.
|
14.3%
1/7 • Number of events 1 • Adverse events are reported by the study arm and randomized visit order.
|
|
Nervous system disorders
Light Headedness
|
0.00%
0/7 • Adverse events are reported by the study arm and randomized visit order.
|
14.3%
1/7 • Number of events 1 • Adverse events are reported by the study arm and randomized visit order.
|
0.00%
0/7 • Adverse events are reported by the study arm and randomized visit order.
|
0.00%
0/7 • Adverse events are reported by the study arm and randomized visit order.
|
Additional Information
Robert Sherwin, MD
Department of Internal Medicine and Endocrinology, Yale University School of Medicine, New Haven, CT
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place