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| ID | Type | Description | Link |
|---|---|---|---|
| R37-20495 | Other Grant/Funding Number | NIDDK |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 Diabetics | Active Comparator | The active group were participants with type 1 diabetes. |
|
| Healthy Volunteers | Other | The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formoterol | Drug | Formoterol inhaler, 12mcg capsules, 4 capsules for one administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon (pg/mL) | 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. | up to 120 minutes |
| Epinephrine (pg/mL) | 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 | up to 120 minutes |
| Norepinephrine (pg/mL) | 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 | up to 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose Levels (Average) | 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. | Up to 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Sherwin, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26153273 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control: Placebo | Healthy volunteers that received Placebo first, the Formoterol. |
| FG001 | Control: Formoterol | Healthy volunteers that received Formoterol first, then Placebo. |
| FG002 | Type 1 Diabetics: Placebo | Type 1 Diabetics that received Placebo first, then Formoterol. |
| FG003 | Type 1 Diabetics: Formoterol | Type 1 Diabetics that received Formoterol first, then Placebo. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glucagon (pg/mL) | 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. | Results are pooled at the arm level and split by placebo and control regardless of randomization order. | Posted | Mean | Standard Error | pg/mL | up to 120 minutes |
|
Adverse events are reported by the study arm and randomized visit order.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control: Placebo | Healthy volunteers that received Placebo on the first visit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shakiness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Sherwin, MD | Department of Internal Medicine and Endocrinology, Yale University School of Medicine, New Haven, CT | (203) 785-3482 | robert.sherwin@yale.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Other | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI, kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| HbA1c (%) | Mean | Standard Deviation | % |
|
| HbA1c (mmol/mol) | Mean | Standard Deviation | mmol/mol |
|
Healthy volunteers that received Formoterol on the first or second visit.
| OG002 | Type 1 Diabetics: Placebo | Type 1 Diabetics that received placebo on the first or second visit. |
| OG003 | Type 1 Diabetics: Formoterol | Type 1 Diabetics that received Formoterol on the first or second visit. |
|
|
| Secondary | Blood Glucose Levels (Average) | 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. | Subjects are pooled across randomized conditions in their respective study arms and reported overall. | Posted | Mean | Standard Deviation | mg/dL | Up to 120 minutes |
|
|
|
| Primary | Epinephrine (pg/mL) | 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 | Results are pooled at the arm level and split by placebo and control regardless of randomization order. | Posted | Mean | Standard Error | pg/mL | up to 120 minutes |
|
|
|
| Primary | Norepinephrine (pg/mL) | 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 | Results are pooled at the arm level and split by placebo and control regardless of randomization order. | Posted | Mean | Standard Error | pg/mL | up to 120 minutes |
|
|
|
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | Control: Formoterol | Healthy volunteers that received Formoterol on the first visit. | 0 | 7 | 3 | 7 |
| EG002 | Type 1 Diabetics: Placebo | Type 1 Diabetics that received placebo on the first visit. | 0 | 7 | 0 | 7 |
| EG003 | Type 1 Diabetics: Formoterol | Type 1 Diabetics that received Formoterol on the first visit. | 0 | 7 | 2 | 7 |
| Hunger | General disorders | Systematic Assessment |
|
| Tiredness | General disorders | Systematic Assessment |
|
| Mild Palpitations | Cardiac disorders | Systematic Assessment |
|
| Light Headedness | Nervous system disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| Euglycemia |
|
| Hypoglycemia |
|
| Euglycemia |
|
| Hypoglycemia |
|