Trial · NCT03538015
Carvedilol in Treating Hypoglycemia Unawareness
NCT03538015, Phase 2, Terminated, Owen Chan, PhD; results first posted 2020-09-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Carvedilol in Treating Hypoglycemia Unawareness. Trials, record NCT03538015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03538015
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Carvedilol in Treating Hypoglycemia Unawareness
- NCT number
- NCT03538015
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Owen Chan, PhD
- Conditions
- Hypoglycemia Unawareness
- Interventions
- Carvedilol 3.125 mg, Carvedilol 2.5 mg, Placebo capsule
- First posted
- 2018-05-25
- Last updated
- 2020-11-25
- Results first posted
- 2020-09-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hypoglycemia Symptom Score | Baseline and 4 Weeks | 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. |
| Secondary | Change in Blood Glucagon | Baseline and 4 Weeks | 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. |
| Secondary | Change in Blood Epinephrine | Baseline and 4 Weeks | 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. |
| Secondary | Change in Blood Norepinephrine | Baseline and 4 Weeks | 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. |
| Secondary | Change in Blood Cortisol | Baseline and 4 Weeks | 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. |
| Secondary | Change in Blood Growth Hormone | Baseline and 4 Weeks | 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. |
| Secondary | Frequency of CGM-Determined Hypoglycemic Episodes | 5 Weeks | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Hypoglycemia Symptom Score | Baseline and 4 Weeks | Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting. | ||
| SECONDARY | Change in Blood Glucagon | Baseline and 4 Weeks | Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting. | ||
| SECONDARY | Change in Blood Epinephrine | Baseline and 4 Weeks | Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting. | ||
| SECONDARY | Change in Blood Norepinephrine | Baseline and 4 Weeks | Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting. | ||
| SECONDARY | Change in Blood Cortisol | Baseline and 4 Weeks | Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting. | ||
| SECONDARY | Change in Blood Growth Hormone | Baseline and 4 Weeks | Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting. | ||
| SECONDARY | Frequency of CGM-Determined Hypoglycemic Episodes | 5 Weeks | Study terminated due to low enrollment. Subject did not complete the study and data were not collected to enable results reporting. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carvedilol 3.125 mg | 0 | |
| Overall Study | STARTED | Carvedilol 2.5 mg | 0 | |
| Overall Study | STARTED | Placebo Capsule | 1 | |
| Overall Study | COMPLETED | Carvedilol 3.125 mg | 0 | |
| Overall Study | COMPLETED | Carvedilol 2.5 mg | 0 | |
| Overall Study | COMPLETED | Placebo Capsule | 0 | |
| Overall Study | NOT COMPLETED | Carvedilol 3.125 mg | 0 | |
| Overall Study | NOT COMPLETED | Carvedilol 2.5 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo Capsule | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carvedilol 3.125 mg | 0 | 0 |
| Total, all-cause mortality | Carvedilol 2.5 mg | 0 | 0 |
| Total, all-cause mortality | Placebo Capsule | 0 | 1 |
| Total, other adverse events | Carvedilol 3.125 mg | 0 | 0 |
| Total, other adverse events | Carvedilol 2.5 mg | 0 | 0 |
| Total, other adverse events | Placebo Capsule | 0 | 1 |
| Total, serious adverse events | Carvedilol 3.125 mg | 0 | 0 |
| Total, serious adverse events | Carvedilol 2.5 mg | 0 | 0 |
| Total, serious adverse events | Placebo Capsule | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03538015
GET https://conductscience.org/api/trials/v1/NCT03538015/registered