Trial Outcomes & Findings for Propranolol in Treating Hypoglycemia Unawareness (NCT NCT03161964)
NCT ID: NCT03161964
Last Updated: 2020-08-24
Results Overview
A subject's self-reported hypoglycemic episode is defined by a hypoglycemic symptom record on the hypoglycemia diary with a confirmatory glucose value (glucometer value \< 70 mg/dL), or an incidental glucometer value \< 70 mg/dL if no hypoglycemia symptom develops. A single CGM hypoglycemic episode is defined by any CGM readings \< 70 mg/dL, followed by at least one reading ≥ 70 mg/dL from the Dexcom Professional Mobile CGM system. Self-reported and CGM assessment of hypoglycemic episodes will be conducted for two weeks before study drug intervention and two weeks after study drug intervention. The average change in the ratio of self-reported hypoglycemic episodes to total (CGM) episodes will be compared between the propranolol and placebo treatment arms
TERMINATED
PHASE2
2 participants
2 weeks
2020-08-24
Participant Flow
Participant milestones
| Measure |
Propranolol
After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Propranolol Arm will be treated with Propranolol 80 Mg Oral Capsule, Extended Release daily for four weeks.
Propranolol 80 Mg Oral Capsule, Extended Release: Propranolol capsule over-encapsulated to match placebo for blinding
|
Placebo
After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Placebo Arm will be treated with matching placebo oral capsule daily for four weeks.
Placebo oral capsule: Placebo capsule over-encapsulated to match propranolol for blinding
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Propranolol in Treating Hypoglycemia Unawareness
Baseline characteristics by cohort
| Measure |
Propranolol
n=1 Participants
After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Propranolol Arm will be treated with Propranolol 80 Mg Oral Capsule, Extended Release daily for four weeks.
Propranolol 80 Mg Oral Capsule, Extended Release: Propranolol capsule over-encapsulated to match placebo for blinding
|
Placebo
n=1 Participants
After enrollment and the initial two-week continuous glucose monitoring assessment, study subjects randomized to the Placebo Arm will be treated with matching placebo oral capsule daily for four weeks.
Placebo oral capsule: Placebo capsule over-encapsulated to match propranolol for blinding
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
A subject's self-reported hypoglycemic episode is defined by a hypoglycemic symptom record on the hypoglycemia diary with a confirmatory glucose value (glucometer value \< 70 mg/dL), or an incidental glucometer value \< 70 mg/dL if no hypoglycemia symptom develops. A single CGM hypoglycemic episode is defined by any CGM readings \< 70 mg/dL, followed by at least one reading ≥ 70 mg/dL from the Dexcom Professional Mobile CGM system. Self-reported and CGM assessment of hypoglycemic episodes will be conducted for two weeks before study drug intervention and two weeks after study drug intervention. The average change in the ratio of self-reported hypoglycemic episodes to total (CGM) episodes will be compared between the propranolol and placebo treatment arms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Subjects will complete the Gold questionnaire for hypoglycemia awareness at the baseline and at the last visit of the intervention period. The Gold questionnaire is comprised of one question to evaluate the hypoglycemia awareness, with scores from 1 to 7, representing from normal to minimal/no hypoglycemia awareness. The average change in Gold questionnaire score from baseline to the last visit will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Subjects will complete the Clarke questionnaire for hypoglycemia awareness at the baseline and at the last visit of the intervention period. The Clarke questionnaire is comprised of eight questions to evaluate the hypoglycemia awareness. The answer for each individual question will represent a score (0 or 1). These scores will be summed together to a final score from 0 to 7, representing from normal to minimal/no hypoglycemia awareness. The average change in Clarke questionnaire score from baseline to the last visit will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Subjects will complete the Pederson-Bjergaard questionnaire for hypoglycemia awareness at the baseline and at the last visit of the intervention period. The Pederson-Bjergaard questionnaire is comprised of one question to evaluate the hypoglycemia awareness, with answers of "Always", "sometimes", "occasionally", "never" or "Do not know". Each answer will represent an awareness status. The change in Pederson-Bjergaard questionnaire status from baseline to the last visit will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Nadir glucose level during each hypoglycemic episode will be detected by CGM during a 2-week interval at baseline and at the end of the treatment period. The average of nadir blood glucose levels will be calculated and the change will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Nadir glucose level during each hypoglycemic episode will be detected by CGM during a 2-week interval at baseline and at the end of the treatment period. The number of hypoglycemic events will be totaled in the severity categories of nadir glucose level: \< 70 mg/dL; \< 60 mg/dL; \< 56 mg/dL; \< 50 mg/dL; and \< 40 mg/dL. The change in the number of hypoglycemic events in these categories will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Duration of hypoglycemia will be detected by CGM during a 2-week interval at baseline and at the end of the treatment period. The total duration of hypoglycemia (in minutes) will be calculated for each duration categories of hypoglycemia: \<15 minutes, ≥ 15 minutes, ≥ 30 minutes, ≥ 45 minutes and ≥ 60 minutes. The change in the total time of hypoglycemia in these categories will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Blood glucose will be detected by CGM during a 2-week interval at baseline and at the end of the treatment period. The AUC of blood glucose will be calculated for each severity categories of nadir glucose level: \< 70 mg/dL; \< 60 mg/dL; \< 56 mg/dL; \< 50 mg/dL; and \< 40 mg/dL. The change in AUC of these categories will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
The time of hypoglycemic symptom and glucometer reading of each hypoglycemic episode will be documented by study subjects in the hypoglycemia diary, and the onset time of hypoglycemia will be detected by CGM during a 2-week interval at baseline and at the end of the treatment period. The duration of hypoglycemia onset-to-diagnosis will be calculated as the time difference between hypoglycemia onset as recorded on CGM, and documented hypoglycemic symptom and glucometer reading, whichever is the earliest. The change in the average duration of hypoglycemia onset-to-diagnosis will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
The time of hypoglycemia treatment of each hypoglycemic episode will be documented by study subjects in the hypoglycemia diary, and the onset time of hypoglycemia will be detected by CGM during a 2-week interval at baseline and at the end of the treatment period. The duration of hypoglycemia onset-to-treatment will be calculated as the time difference between hypoglycemia onset as recorded on CGM, and documented hypoglycemia treatment. The change in the average duration of hypoglycemia onset-to-treatment will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
The time of hypoglycemic symptom and glucometer reading of each hypoglycemic episode will be documented by study subjects in the hypoglycemia diary, and the recovery time of hypoglycemia will be detected by CGM during a 2-week interval at baseline and at the end of the treatment period. The duration of hypoglycemia diagnosis-to-recovery will be calculated as the time difference between the documented hypoglycemic symptom and glucometer reading, whichever is the earliest, and hypoglycemia recovery as recorded on CGM. The change in the average duration of hypoglycemia diagnosis-to-recovery will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
The time of hypoglycemia treatment of each hypoglycemic episode will be documented by study subjects in the hypoglycemia diary, and the recovery time of hypoglycemia will be detected by CGM during a 2-week interval at baseline and at the end of the treatment period. The duration of hypoglycemia treatment-to-recovery will be calculated as the time difference between the documented hypoglycemia treatment and hypoglycemia recovery as recorded on CGM. The change in the average duration of hypoglycemia treatment-to-recovery will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Hypoglycemia will be reported by patients detected by CGM during a 2-week interval at the baseline and at end of the treatment period. The total number of hypoglycemic episodes as defined by CGM readings of \< 70 mg/dL will be counted, and the changes in the number will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weekPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Severe hypoglycemia is a clinical event defined by any hypoglycemic episode requiring outside help in the treatment administration of the particular hypoglycemic episode. Severe hypoglycemia episodes will be recorded by hypoglycemia diary during a 2-week interval at baseline and at the end of the treatment period. The total number of hypoglycemia/severe hypoglycemia episodes as defined by CGM readings of \< 70 mg/dL will be counted and the change will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Subjects will complete the Fear of Hypoglycemia Questionnaire at baseline and the last visit of the intervention period. The average change in Fear of Hypoglycemia Questionnaire score from baseline to 4 weeks will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis conducted due to small sample size; study terminated due to low enrollment.
Blood glucose will be detected by CGM during a 2-week interval at the baseline and at the end of the treatment period. The average change will be compared between the propranolol and placebo treatment arms.
Outcome measures
Outcome data not reported
Adverse Events
Propranolol
Placebo
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