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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

Approved for 20 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 30, 60, 90, 120, 180 and 240 minutes post 5mg oral glipizide dose, day 1 (visit 1)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Fasting Glucagon at Visit 1 and Visit 2 by Genotype for rs7903146

Incretin Levels

Metabolomics

+2 more

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met