Metformin + Glipizide for Diabetes
(SUGAR-MGH Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJose C Florez, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

The SUGAR-MGH investigators are studying the influence of inherited gene variants on the response to two commonly prescribed type 2 diabetes medications, metformin and glipizide. They hypothesize that variants in genes that are associated with type 2 diabetes or related traits may impact the effect of anti-diabetic medications. In addition, physiological responses to an insulin secretagogue or an insulin sensitizer may shed light on the mechanism of action of reported genetic associations.

Research Team

Jose C Florez, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

Otherwise healthy subjects may also be candidates for the study

I am willing to consent to genetic testing.

The first tier of risk will be illustrated by one of the following variables (e.g. established type 2 diabetes on diet therapy alone, elevated random glucose in electronic medical record, PCOS, metabolic syndrome, obesity, history of gestational diabetes, etc.)

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Exclusion Criteria

Known severe allergic reactions to sulfonamides

Enrolled in any other interventional study at time of screening through completion of study protocol

My family has a history of diabetes starting before age 25 across three generations.

See 12 more

Treatment Details

Interventions

Glipizide (Sulfonylurea)
Metformin (Biguanide)

Trial OverviewThe 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.

Participant Groups

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.