Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01762046

Run by

Massachusetts General Hospital

People needed

1033

Starts

2008-01-01

Expected to finish

2025-12-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or non-pregnant female > 18 years of age
• Investigators will target preferentially people at risk of diabetes or requiring diabetes meds
• 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.)
• The second tier of risk will be illustrated by other features that correlate with diabetes risk, such as a history of hypertension or dyslipidemia
• Otherwise healthy subjects may also be candidates for the study.
• Able and willing to give consent relevant to genetic investigation

You may not qualify if…

• Pregnant, nursing or at risk of becoming pregnant
• Currently taking any medications for the treatment of diabetes
• Currently on metformin for any other indication (e.g. PCOS)
• Onset of diabetes in a family member before age 25, with autosomal transmission of diabetes across three generations
• History of liver or kidney disease
• Known severe allergic reactions to sulfonamides
• History of porphyria
• Documented estimated glomerular filtration rate (GFR) < 60 ml/min/1.73 m2, based on the most recent serum creatinine measurement available in the electronic medical record, and calculated by the Modification of Diet in Renal Disease equation (49) available at http://www.nephron.com/cgi-bin/MDRD_GFR.cgi
• Currently taking medications known to affect glycemic parameters, such as glucocorticoids, growth hormone or fluoroquinolones
• Planned radiologic or angiographic study requiring contrast within one week of completion of this study
• Established coronary artery disease (CAD), defined as:
• History of myocardial infarction.
• History of revascularization (coronary artery bypass grafting, percutaneous coronary intervention (e.g. stenting or balloon angioplasty).
• Evidence of ischemia on cardiac stress test.
• Enrolled in any other interventional study at time of screening through completion of study protocol
• History of bariatric surgery
• History of seizures
• History of stroke/CVA

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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