Evaluation of the Metformin Effect on Methylglyoxal in Patients With Type 2 Diabetes

Summary

This study is designed to investigate the effects of metformin, a commonly prescribed first line medication for diabetes and recommended for prediabetes, on the levels of the potentially tissue damaging reactive product (MG) in the blood and its cleared counterpart in the urine (IMZ). The study will involve patients with elevated HbA1c randomized to receive either metformin or a similar inactive placebo pill and a group of sex and age matched volunteers without diabetes. Study participants will be recruited from the University of Arizona Medical Center, South Campus clinics (Endocrine clinic, family medicine clinic and general medicine clinic). Eighty patients with HbA1c \>6.0% will be randomized to receive either metformin or a similar inactive placebo for 6 weeks. The response of these patients will be compared to 40 patients normal HbA1c \<5.6% who will not receive either study medication. Investigators will compare the plasma MG and urine IMZ concentration/content between the 3 groups before and after the 6-week intervention. It is hypothesized that plasma MG level in the metformin treatment group will be less than in the group taking the placebo pills, while there will be no significant difference in MG level between the metformin treatment group and the volunteers without diabetes.

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

Metformin Hydrochloride (500-mg capsule)

Metformin hydrochloride tablets (500-mg) are manufactured by Heritage Pharma INC. Noha Ashy \& David Lee will ground the tablets and put them in capsules to avoid differentiation between treatment and placebo. Using USP 797 compounding standers, Noha Ashy \& David Lee will package the capsules to conceal it from the participants and other investigators. Compounding will take place at the lab, College of Pharmacy (Darchman building, 2nd floor), University of Arizona. New empty capsules (size 0, ½ blue-opaque and ½ white-opaque capsule which will be supplied by Letco Medical) will be provided to the treatment (metformin hydrochloride) arm participants that are similar to the placebo (comparator) capsules in term of color and size to conceal placebo from the investigators and participants.

DRUG

Calcium carbonate (placebo)

Investigators will use powder of calcium carbonate as filler of placebo capsules. Placebo capsules (size 0,½ blue-opaque and ½white-opaque capsule which will be supplied by Letco Medical),will be provided to the comparator arms' participants that are similar to the metformin hydrochloride capsules in term of color and size to conceal placebo from the investigators and participants.Using USP 797 compounding standers, Noha Ashy \& David Lee will package the capsules to conceal it from the participants and other investigators. Compounding will take place at the lab, College of Pharmacy (Darchman building, 2nd floor), University of Arizona.

OTHER

Glucometer (One Touch glucometer), strips and lancets

Investigators will provide glucometer (One Touch glucometer), strips and lancets to the treatment and placebo groups. They will be provided to patients who never had glucometer before enrolling to our study.Also, a logbook will be provided to each participant to record their blood sugar measurements at home.

OTHER

Urine container for 24-hour urine collection

During visit 2 (day 0) and visit 3 (day 42), urine container will be provided to the study participant for 24-hour urine collection. Patient will be instructed to bring the container back to the collaboratory. Investigators will transfer the urine container to Dr.Lau's lab to measure the IMZ concentration/content.

Sponsors & Collaborators

• University of Arizona

  lead OTHER

Principal Investigators

• Serrine S Lau, PhD · University of Arizona

• Craig Stump, MD, PhD · University of Arizona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2017-08-31

Completion

2017-08-31