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GPR119 Agonist for Type 1 Diabetes (PHROG Trial)
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.
PHROG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPHROG Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PHROG Trial Design
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Who is running the clinical trial?
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- You have signs of autonomic nerve damage.I have a history of HIV, Hepatitis B or C, or Tuberculosis.You have not had heart problems in the past 6 months or currently have a pacemaker or defibrillator.You have been diagnosed with major depression in the last 5 years.I am over 20 years old.I haven't started or changed any hormone therapy in the last 3 months.I have high cholesterol or triglycerides but have been on stable treatment for the last 3 months.I only use insulin to manage my type 1 diabetes.You have a thyroid condition with abnormal levels of thyroid-stimulating hormone (TSH).My BMI is either above 30 or below 18.5.I am using or willing to use effective birth control during the study.For the group of healthy participants: Your fasting blood sugar level is between 70 mg/dL and 100 mg/dL.If you have type 1 diabetes, your heart's electrical activity should not show a QTcF measurement of over 450 ms for males or 470 ms for females.You have had type 1 diabetes for more than 5 years.I have never been diagnosed with diabetes.I have had two or more severe low blood sugar episodes per month in the last six months.You currently work at night.For the healthy group, you should be in good overall health.I have only been diagnosed with type 1 diabetes, not type 2 or any other form.I have type 1 diabetes without severe eye, kidney, or nerve damage.I have had an organ transplant.My liver enzymes are not more than 2.5 times the normal limit.You have low levels of hemoglobin in your blood.My kidneys are functioning well, with a creatinine clearance rate above 80 mL/min.I have Type 1 diabetes and need insulin to live.You are unaware when your blood sugar gets too low, as determined by the GOLD score.You have had an eating disorder in the past.I use advanced tech for diabetes management but can stop if I join the study.I agree not to conceive or donate sperm during and for 2 weeks after the study.I do not have any mental health conditions that would stop me from following the study's requirements.I am taking medication for high blood sugar.You have a history of regularly drinking more than three alcoholic drinks per day or using drugs in the past five years.I am over 20 years old and have Type 1 diabetes.Your fasting C-peptide levels are very low and your blood sugar levels are high.I haven't taken medications affecting my metabolism in the last 3 months.I have had weight loss surgery in the past.I am not on insulin treatment.My blood pressure is not controlled with 2 or fewer medications.I am currently using beta-blockers or stopped them less than a month ago.I have not had cancer, except for non-melanoma skin cancer, in the last 5 years.My kidney function is impaired.
- Group 1: Placebo first then MBX-2982- Volunteers with Type 1 diabetes
- Group 2: Healthy Volunteers
- Group 3: MBX-2982 first then placebo- Volunteers with Type 1 diabetes
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
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