NCT01762046CompletedPhase 1
Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 1033 (actual)
- First submitted
- 28 Dec 2012
- Start date
- Jan 2008
- Primary completion date
- Dec 2015
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT01762046
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 1033
- From Jan 2008 to the primary completion date, Dec 2015
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking any medications for the treatment of diabetes
- Currently on metformin for any other indication (e.g. PCOS)
- Currently taking medications known to affect glycemic parameters, such as glucocorticoids, growth hormone or fluoroquinolones
Other illness
- History of liver or kidney disease
- Known severe allergic reactions to sulfonamides
- History of porphyria
- 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.
- History of bariatric surgery
- History of seizures
- History of stroke/CVA
Lab values
- 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
Age
- Onset of diabetes in a family member before age 25, with autosomal transmission of diabetes across three generations
Other
- Pregnant, nursing or at risk of becoming pregnant
- Planned radiologic or angiographic study requiring contrast within one week of completion of this study
- Enrolled in any other interventional study at time of screening through completion of study protocol
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Joslin Diabetes Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
Related publications
- TCF7L2 Genetic Variation Augments Incretin Resistance and Influences Response to a Sulfonylurea and Metformin: The Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans (SUGAR-MGH).Diabetes Care · 2018 · PMID 29326107
- The study to understand the genetics of the acute response to metformin and glipizide in humans (SUGAR-MGH): design of a pharmacogenetic resource for type 2 diabetes.PLoS One · 2015 · PMID 25812009
This page is information, not medical advice. Discuss any trial with your doctor.