Trial · NCT04432090
GPR119 Agonist for Hypoglycemia in Type 1 Diabetes
NCT04432090, Phase 2, Completed, AdventHealth Translational Research Institute; results first posted 2024-10-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GPR119 Agonist for Hypoglycemia in Type 1 Diabetes. Trials, record NCT04432090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04432090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GPR119 Agonist for Hypoglycemia in Type 1 Diabetes
- NCT number
- NCT04432090
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- AdventHealth Translational Research Institute
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Placebo, Study Medication (MBX-2982), No medication for this group
- First posted
- 2020-06-16
- Last updated
- 2024-10-17
- Results first posted
- 2024-10-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximal Glucagon Concentration During Hypoglycemia | Day 14, Day 42 | Maximal glucagon concentration during insulin induced hypoglycemia. This was measured during the hypoglycemic steady state of the hyper-insulinemic euglycemic-hypoglycemic clamp study. |
| Primary | Total Area Under the Curve (AUC) for Glucagon During Hypoglycemia. | Day 14, Day 42 | This outcome was measured during the hypoglycemic steady state of the hyper-insulinemic euglycemic hypoglycemic clamp study. Total area under the curve (AUC) for glucagon was measured during the time points of 120 minutes to 140 minutes of the clamp. |
| Primary | Incremental AUC for Glucagon During Hypoglycemia (Above Baseline Levels During Euglycemia) | Day 14, Day 42 | This is the difference between the AUC during the hypoglycemic steady state (time points 120 - 140 mins of clamp) and the baseline glucagon levels during euglycemic steady state (timepoints 60 min - 80 mins of the clamp) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximal Glucagon Concentration During Hypoglycemia | Day 14, Day 42 | pg/mL | MEAN | |
| PRIMARY | Total Area Under the Curve (AUC) for Glucagon During Hypoglycemia. | Day 14, Day 42 | pg*min/mL | MEAN | |
| PRIMARY | Incremental AUC for Glucagon During Hypoglycemia (Above Baseline Levels During Euglycemia) | Day 14, Day 42 | pg*min/mL | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximal Glucagon Concentration During Hypoglycemia | T1D on MBX-2982 | 19.9 | Standard Deviation 12.6 | pg/mL | |
| Maximal Glucagon Concentration During Hypoglycemia | T1D on Placebo | 22.5 | Standard Deviation 16.8 | pg/mL | |
| Maximal Glucagon Concentration During Hypoglycemia | Healthy Normal Volunteers | 82.7 | Standard Deviation 39.7 | pg/mL | |
| Total Area Under the Curve (AUC) for Glucagon During Hypoglycemia. | T1D on MBX-2982 | 6624.6 | Standard Deviation 3772.4 | pg*min/mL | |
| Total Area Under the Curve (AUC) for Glucagon During Hypoglycemia. | T1D on Placebo | 6037.5 | Standard Deviation 3545.9 | pg*min/mL | |
| Total Area Under the Curve (AUC) for Glucagon During Hypoglycemia. | Healthy Normal Volunteers | 15923.2 | Standard Deviation 5350.6 | pg*min/mL | |
| Incremental AUC for Glucagon During Hypoglycemia (Above Baseline Levels During Euglycemia) | T1D on MBX-2982 | 327.9 | Standard Deviation 257.9 | pg*min/mL | |
| Incremental AUC for Glucagon During Hypoglycemia (Above Baseline Levels During Euglycemia) | T1D on Placebo | 467.8 | Standard Deviation 435.7 | pg*min/mL | |
| Incremental AUC for Glucagon During Hypoglycemia (Above Baseline Levels During Euglycemia) | Healthy Normal Volunteers | 2445.4 | Standard Deviation 1346.4 | pg*min/mL |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MBX-2982 First Then Placebo- Volunteers With Type 1 Diabetes | 32 | |
| Overall Study | STARTED | Placebo First Then MBX-2982- Volunteers With Type 1 Diabetes | 32 | |
| Overall Study | STARTED | Healthy Volunteers | 46 | |
| Overall Study | Randomized | MBX-2982 First Then Placebo- Volunteers With Type 1 Diabetes | 13 | |
| Overall Study | Randomized | Placebo First Then MBX-2982- Volunteers With Type 1 Diabetes | 14 | |
| Overall Study | Randomized | Healthy Volunteers | 9 | |
| Overall Study | COMPLETED | MBX-2982 First Then Placebo- Volunteers With Type 1 Diabetes | 9 | |
| Overall Study | COMPLETED | Placebo First Then MBX-2982- Volunteers With Type 1 Diabetes | 9 | |
| Overall Study | COMPLETED | Healthy Volunteers | 9 | |
| Overall Study | NOT COMPLETED | MBX-2982 First Then Placebo- Volunteers With Type 1 Diabetes | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | General disorders | T1D on MBX-2982 | 2 | 18 | |
| other | Headache | General disorders | T1D on Placebo | 5 | 18 | |
| other | Headache | General disorders | Healthy Normal Volunteers | 0 | 9 | |
| other | Nausea, vomiting | Gastrointestinal disorders | T1D on MBX-2982 | 2 | 18 | |
| other | Nausea, vomiting | Gastrointestinal disorders | T1D on Placebo | 2 | 18 | |
| other | Nausea, vomiting | Gastrointestinal disorders | Healthy Normal Volunteers | 0 | 9 | |
| other | Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | T1D on MBX-2982 | 1 | 18 | |
| other | Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | T1D on Placebo | 2 | 18 | |
| other | Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Healthy Normal Volunteers | 0 | 9 | |
| other | Dizziness | Nervous system disorders | T1D on MBX-2982 | 0 | 18 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T1D on MBX-2982 | 0 | 18 |
| Total, all-cause mortality | T1D on Placebo | 0 | 18 |
| Total, all-cause mortality | Healthy Normal Volunteers | 0 | 9 |
| Total, other adverse events | T1D on MBX-2982 | 4 | 18 |
| Total, other adverse events | T1D on Placebo | 5 | 18 |
| Total, other adverse events | Healthy Normal Volunteers | 0 | 9 |
| Total, serious adverse events | T1D on MBX-2982 | 0 | 18 |
| Total, serious adverse events | T1D on Placebo | 0 | 18 |
| Total, serious adverse events | Healthy Normal Volunteers | 0 | 9 |
Source ClinicalTrials.gov
Papers18
The papers the trial lists on ClinicalTrials.gov.
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/NCT04432090
GET https://conductscience.org/api/trials/v1/NCT04432090/events?page=2