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GPR119 Agonist

GPR119 Agonist for Type 1 Diabetes (PHROG Trial)

Phase 2
Waitlist Available
Led By Richard Pratley, MD
Research Sponsored by Translational Research Institute for Metabolism and Diabetes, Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy subject cohort: Age >20 years
Healthy subject cohort: No history of diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14, day 28, 6 hours
Awards & highlights

PHROG Trial Summary

This trial will test if a medication can increase the response to low blood sugar in people with type 1 diabetes, by measuring the response of the body to low blood sugar in healthy people.

Who is the study for?
This trial is for adults over 20 with Type 1 Diabetes Mellitus (T1DM) who've had the condition for more than 5 years and require insulin. They must not plan to conceive during the study. Healthy adults are also needed as a reference group, without diabetes or significant health issues. Participants should not have a history of substance abuse, psychiatric conditions affecting protocol adherence, or severe medical conditions.Check my eligibility
What is being tested?
The study tests if MBX-2982, a GPR119 agonist, can improve the body's response to low blood sugar in people with T1DM compared to placebo or no medication at all. The effects will be measured against responses from healthy individuals.See study design
What are the potential side effects?
Potential side effects aren't specified but could include reactions typical of diabetes medications such as hypoglycemia (very low blood sugar), digestive disturbances, skin reactions at injection sites, and possible allergic reactions.

PHROG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 20 years old.
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I have never been diagnosed with diabetes.
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My kidneys are functioning well, with a creatinine clearance rate above 80 mL/min.
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I have Type 1 diabetes and need insulin to live.
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I agree not to conceive or donate sperm during and for 2 weeks after the study.
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I am over 20 years old and have Type 1 diabetes.

PHROG Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14, day 28, 6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14, day 28, 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glucagon
Maximal glucagon concentration during hypoglycemia
Total area under the curve (AUC) for glucagon during hypoglycemia.

PHROG Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Placebo first then MBX-2982- Volunteers with Type 1 diabetesExperimental Treatment2 Interventions
Group II: MBX-2982 first then placebo- Volunteers with Type 1 diabetesExperimental Treatment2 Interventions
This will be followed by a second study period in which they will be crossed over to the other treatment.
Group III: Healthy VolunteersActive Control1 Intervention
this group will not receive any medication. It will be studied to establish the norm of the measurement that will be performed to obtain the study outcomes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,530 Total Patients Enrolled
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
20,114 Total Patients Enrolled
Richard Pratley, MDPrincipal InvestigatorStudy Principal Investigator
9 Previous Clinical Trials
902 Total Patients Enrolled

Media Library

Study Medication (MBX-2982) (GPR119 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04432090 — Phase 2
Type 1 Diabetes Research Study Groups: Placebo first then MBX-2982- Volunteers with Type 1 diabetes, Healthy Volunteers, MBX-2982 first then placebo- Volunteers with Type 1 diabetes
Type 1 Diabetes Clinical Trial 2023: Study Medication (MBX-2982) Highlights & Side Effects. Trial Name: NCT04432090 — Phase 2
Study Medication (MBX-2982) (GPR119 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04432090 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the cohort involved in this clinical trial?

"Affirmative. Clinicaltrials.gov data confirms the ongoing recruiting of this medical trial, which was initially posted on April 21st 2021 and updated November 16th 2022. A total of 29 patients must be recruited from 1 clinical site."

Answered by AI

Is enrollment currently open for this research project?

"Clinicaltrials.gov affirms that this medical trial is still accepting patients, with the initial posting being on April 21st 2021 and then a subsequent update occurring November 16th 2022."

Answered by AI

Have prior studies engaged Healthy Volunteers in their research?

"Currently, there is one active trial examining Healthy Volunteers. This study has not yet reached Phase 3 and is being hosted in Orlando, Florida with a single location for the trials."

Answered by AI

What safeguards exist to protect test subjects during Healthy Volunteers studies?

"Risk to Healthy Volunteers is adjudged a 2 on our Power scale, indicating that while there is some data attesting to their safety, no precedent exists for the efficacy of this medication."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Met criteria
~17 spots leftby Mar 2025