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NCT04432090: PHROG

GPR119 Agonist for Hypoglycemia in Type 1 Diabetes

Completed Phase 2 Results posted Last updated 17 October 2024
What this trial tests

Phase 2 trial testing Placebo in Diabetes Mellitus, Type 1 in 110 participants. Completed in 12 August 2023.

Timeline
21 April 2021
Primary endpoint
12 August 2023
12 August 2023

Quick facts

Lead sponsorAdventHealth Translational Research Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposebasic science
Enrollment110
Start date21 April 2021
Primary completion12 August 2023
Estimated completion12 August 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

AdventHealth Translational Research Institute

Who can join

Adults 20 to 60, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximal Glucagon Concentration During Hypoglycemia Primary · 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.

GroupValue95% CI
T1D on MBX-298219.9± 12.6
T1D on Placebo22.5± 16.8
Healthy Normal Volunteers82.7± 39.7
Total Area Under the Curve (AUC) for Glucagon During Hypoglycemia. Primary · 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.

GroupValue95% CI
T1D on MBX-29826624.6± 3772.4
T1D on Placebo6037.5± 3545.9
Healthy Normal Volunteers15923.2± 5350.6
Incremental AUC for Glucagon During Hypoglycemia (Above Baseline Levels During Euglycemia) Primary · 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)

GroupValue95% CI
T1D on MBX-2982327.9± 257.9
T1D on Placebo467.8± 435.7
Healthy Normal Volunteers2445.4± 1346.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from screening visit till end of study (day 49).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

T1D on MBX-2982
Serious: 0/18 (0%)
Deaths: 0/18
T1D on Placebo
Serious: 0/18 (0%)
Deaths: 0/18
Healthy Normal Volunteers
Serious: 0/9 (0%)
Deaths: 0/9
Other adverse events (8 terms — click to expand)

ReactionSystemT1D on MBX-2982T1D on PlaceboHealthy Normal Volunteers
HeadacheGeneral disorders
Nausea, vomitingGastrointestinal disorders
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders
DizzinessNervous system disorders
PalpitationsGeneral disorders
Exacerbation of capsulitisMusculoskeletal and connective tissue disorders
swelling of handMusculoskeletal and connective tissue disorders
Neck stiffnessMusculoskeletal and connective tissue disorders

Data from ClinicalTrials.gov NCT04432090 adverse events section.

Sponsor's own description

The purpose of this study is to test if a specific research medication could increase the response to low blood glucose in people with type 1 diabetes. The response of the body to low blood sugar will be measured in healthy people as a reference point.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The past, present, and future physiology and pharmacology of glucagon.
    Capozzi ME, D'Alessio DA, Campbell JE. · · 2022 · cited 76× · PMID 36323234 · DOI 10.1016/j.cmet.2022.10.001
  2. GPCRs involved in metabolic diseases: pharmacotherapeutic development updates.
    Jin C, Chen H, Xie L, Zhou Y, et al · · 2024 · cited 25× · PMID 38326623 · DOI 10.1038/s41401-023-01215-2
  3. Targeting the GPR119/incretin axis: a promising new therapy for metabolic-associated fatty liver disease.
    Zhao J, Zhao Y, Hu Y, Peng J. · · 2021 · cited 21× · PMID 34233623 · DOI 10.1186/s11658-021-00276-7
  4. Native mass spectrometry prescreening of G protein-coupled receptor complexes for cryo-EM structure determination.
    Kim D, Liu W, Viner R, Cherezov V. · · 2024 · cited 2× · PMID 39471802 · DOI 10.1016/j.str.2024.10.004

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

Other AdventHealth Translational Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04432090.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing