Tolerance & Responsiveness Improvement for Metformin (TRIM)

Inclusion criteria

• Male (M)
• African American (AA) race
• Age 20-70 years
• BMI 28-59 kg/m2
• T2D
• A1c 6.5 - 8.9%
• eGFR =/> 30
• Drug-naïve or use Glipizide or newly started on Metformin (within 2 weeks).

Exclusion criteria

• Chronic kidney disease stage 3b, 4 and 5 (eGFR < 30)
• Insulin use
• Oral steroids use (inhalers and creams are allowed)
• Antibiotic use within the last month
• Artificial heart valves
• Hospitalization for chronic condition within 6 months prior to the study
• History, manifestations or medications of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric/ psychological disorders, or social circumstances which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject.
• Use of other antidiabetic drugs (except glipizide and metformin).
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

Additional Exclusion criteria for subjects who previously used Metformin:

• Previous severe allergic reaction to metformin hydrochloride, such as angioedema.
• Previous Metformin intolerance causing significant diarrhea or GI-upset. Would not exclude participants who had history of mild diarrhea with metformin use.
• Previous side effects that the subject feels were related to Metformin and the subject is not interested to re-try metformin.