Evaluation of the metformin scavenging mechanism on methylglyoxal in patients with type 2 diabetes mellitus

This study will evaluate the effect of metformin at the usual target dose for patients with prediabetes and patients wirh type 2 diabetic on the plasma methylglyoxal (MG) and urine metformin-MG IMZ cyclized product (IMZ) levels, which will be compared to the MG and IMZ levels of the matched non-diabetic patients

Study phase: N/A

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Inclusion criteria:
- Adult patients (age 18-65 years old),
- Elevated HbA1c > 6.0% (patients with type 2 diabetes mellitus or prediabetes), HbA1C < 9.0%
-For matched non-diabetic patients: HbA1C ? 5.6%
-Serum creatinine (SCr) < 1.5 mg/dL in males or < 1.4 mg/dL in females,
-Calculated glomerular filtration rate (GFR) > 60 ml/min/1.73m2,
-Body mass index (BMI) 25-40 kg/m2,
-Glycosylated hemoglobin A1C (HA1C) < 9%,
-No known intolerance to metformin
-Has not taken metformin previous 3 months

Exclusion criteria:
-Patients on thiazolidinediones (TZD)
-Patients with history of metformin intolerance (gastrointestinal side effects or poor renal function;
Serum Cr > 1.5mg/dL in males or > 1.4 mg/dL in females or calculated GFR < 60 mL/min/1.73m2
-Patients with active (symptomatic or unstable) cardiovascular disease
-Patients requiring home oxygen
-Patients with end-stage liver disease (cirrhosis)
-Patients on oral glucocorticoids within the past 30 days (equivalent to prednisone > 5mg/day)
-Pregnancy

Additional information:

Each subject will be paid $ 40 totally if the study subjects complete all the study visits as a compensation for their time. The metformin capsules which will be provided free of charge for participants who are in the treatment arm, and placebo capsules will be provided free of charge for participants who are in the comparator arm. The matched non-diabetic patients will not receive either metformin or placebo.

Primary disease category: Diabetes & Endocrine System

This study is enrolling healthy volunteers.

Projected enrollment dates: August 2015 to August 2017

Official study title: Evaluation of the metformin scavenging mechanism on methylglyoxal in patients with type 2 diabetes mellitus

External link(s):
College of Pharmacy