Trial Outcomes & Findings for Carvedilol in Treating Hypoglycemia Unawareness (NCT NCT03538015)
NCT ID: NCT03538015
Last Updated: 2020-11-25
Results Overview
Participants will complete the Edinburgh Hypoglycemia Symptom questionnaire at baseline and after the 4-week treatment period. The average change in hypoglycemia symptom score will be compared between the carvedilol and placebo groups.
TERMINATED
PHASE2
1 participants
Baseline and 4 Weeks
2020-11-25
Participant Flow
Participant milestones
| Measure |
Carvedilol 3.125 mg
After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.
Carvedilol 3.125 mg: Participants will receive a 3.125 mg oral dose of carvedilol twice daily during the 4-week treatment period
|
Carvedilol 2.5 mg
After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.
Carvedilol 2.5 mg: Participants will receive a 2.5 mg oral dose of carvedilol twice daily during the 4-week treatment period
|
Placebo Capsule
After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of placebo treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.
Placebo capsule: Participants will receive a matching oral dose of placebo capsule twice daily during the 4-week treatment period
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carvedilol in Treating Hypoglycemia Unawareness
Baseline characteristics by cohort
| Measure |
Carvedilol 3.125 mg
After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.
Carvedilol 3.125 mg: Participants will receive a 3.125 mg oral dose of carvedilol twice daily during the 4-week treatment period
|
Carvedilol 2.5 mg
After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of low-dose carvedilol treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.
Carvedilol 2.5 mg: Participants will receive a 2.5 mg oral dose of carvedilol twice daily during the 4-week treatment period
|
Placebo Capsule
n=1 Participants
After enrollment, participants will be placed on continuous glucose monitoring (CGM). One week after CGM placement, participants will undergo the first hypoglycemic clamp study to obtain baseline measures of hypoglycemia frequency, hypoglycemia awareness scores and hormone responses. Following the initial clamp procedure, participants will receive 4 weeks of placebo treatment. After 4 weeks of treatment, the participants will undergo a second hypoglycemic clamp session.
Placebo capsule: Participants will receive a matching oral dose of placebo capsule twice daily during the 4-week treatment period
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 WeeksPopulation: Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting.
Participants will complete the Edinburgh Hypoglycemia Symptom questionnaire at baseline and after the 4-week treatment period. The average change in hypoglycemia symptom score will be compared between the carvedilol and placebo groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 4 WeeksPopulation: Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting.
Blood samples will be drawn from study participants at baseline and after the 4-week treatment period during the clamp procedure. The average change in blood glucagon level will be compared between the carvedilol and placebo groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 4 WeeksPopulation: Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting.
Blood samples will be drawn from study participants at baseline and after the 4-week treatment period during the clamp procedure. The average change in blood epinephrine level will be compared between the carvedilol and placebo groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 4 WeeksPopulation: Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting.
Blood samples will be drawn from study participants at baseline and after the 4-week treatment period during the clamp procedure. The average change in blood norepinephrine level will be compared between the carvedilol and placebo groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 4 WeeksPopulation: Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting.
Blood samples will be drawn from study participants at baseline and after the 4-week treatment period during the clamp procedure. The average change in blood cortisol level will be compared between the carvedilol and placebo groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 4 WeeksPopulation: Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting.
Blood samples will be drawn from study participants at baseline and after the 4-week treatment period during the clamp procedure. The average change in blood growth hormone level will be compared between the carvedilol and placebo groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 WeeksPopulation: Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting.
The number of hypoglycemic episodes as determined by CGM will be determined during the 4-week treatment period and compared to the 1-week pre-study baseline period.
Outcome measures
Outcome data not reported
Adverse Events
Carvedilol 3.125 mg
Carvedilol 2.5 mg
Placebo Capsule
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place