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Sulfonylurea

Metformin + Glipizide for Diabetes (SUGAR-MGH Trial)

Phase 1
Waitlist Available
Led By Jose C Florez, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Onset of diabetes in a family member before age 25, with autosomal transmission of diabetes across three generations
Planned radiologic or angiographic study requiring contrast within one week of completion of this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Summary

This trial is looking at how our genes might affect how well two diabetes medications, metformin and glipizide, work. They believe that certain gene variations linked to diabetes could impact how these

Who is the study for?
This trial is for adults over 18 who may be at risk of type 2 diabetes or are already managing it with diet alone. This includes those with elevated glucose levels, PCOS, metabolic syndrome, obesity, or a history of gestational diabetes. People with related risks like hypertension or dyslipidemia can also join if they're healthy overall and willing to consent to genetic research.
What is being tested?
The study is examining how gene variants affect responses to metformin and glipizide—two drugs used for treating type 2 diabetes. It involves an oral glucose tolerance test to understand the action mechanism of these medications in relation to specific genetic profiles.
What are the potential side effects?
Metformin may cause stomach upset, diarrhea, muscle pain, or a metallic taste in the mouth. Glipizide can lead to low blood sugar symptoms like dizziness and sweating; both drugs might have other less common side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My family has a history of diabetes starting before age 25 across three generations.
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I am scheduled for a scan or angiogram with contrast within a week after this study ends.
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I have a history of heart issues like a heart attack or procedures to open my heart's arteries.
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I have a history of seizures.
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I have had liver or kidney disease in the past.
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I have had weight loss surgery in the past.
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I have had a stroke in the past.
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I have a history of porphyria.
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I am currently on medication for diabetes.
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I am taking medication that can affect my blood sugar levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 30, 60, 90, 120, 180 and 240 minutes post 5mg oral glipizide dose, day 1 (visit 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 30, 60, 90, 120, 180 and 240 minutes post 5mg oral glipizide dose, day 1 (visit 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glipizide Response as Measured by Area Over the Glucose Curve Between Time 0 and 240 Minutes According to Genotype
Glipizide Response as Measured by Area Under the Insulin Curve Between Time 0 and 240 Minutes According to Genotype
Metformin Response - Change in Fasting Glucose From Visit 1 to Visit 2
+1 more
Secondary outcome measures
Fasting Glucagon at Visit 1 and Visit 2 by Genotype for rs7903146
Incretin Levels
Metabolomics
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Glipizide and MetforminExperimental Treatment3 Interventions
On day 1, subjects will receive a single oral dose of glipizide 5 mg, and will have blood drawn at various time points for up to 240 minutes. During study days 2-7, the participants will fill out a dietary intake food record, including 3 weekdays and one weekend day. During days 6-8, the subject will receive a short-course metformin treatment of four 500-mg doses. On the morning of study day 8, 60 minutes after taking the fourth metformin dose, the subject will do a 75g Oral Glucose Tolerance Test. Blood draws will again be taken at time points for 120 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glipizide
FDA approved
Metformin
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Joslin Diabetes CenterOTHER
96 Previous Clinical Trials
25,574 Total Patients Enrolled
Broad InstituteOTHER
19 Previous Clinical Trials
15,277 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,955 Previous Clinical Trials
13,211,645 Total Patients Enrolled
~58 spots leftby Sep 2025
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