Trial | NCT03670043  Report issue

Title

Tolerance & Responsiveness Improvement for Metformin (TRIM)
Tolerance & Responsiveness Improvement for Metformin (TRIM): Open-label, Parallel-group Randomized Trial, Phase 4

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    29
The overall goal is to explore the hypothesis that prebiotic fiber Psyllium will ameliorate diarrhea in African American men (AAM) with Type2 Diabetes Mellitus (T2D).
Study Started
Mar 19
2019
Primary Completion
Oct 15
2020
Study Completion
Aug 15
2021
Last Update
Sep 10
2021

Drug Psyllium powder

To evaluate whether Psyllium will alleviate diarrhea

Drug Metformin Extended Release Oral Tablet

Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin

Metformin ER Active Comparator

The subjects developing GI-related symptoms with metformin will be randomized to Metformin Extended Release (ER)

Psyllium Experimental

The subjects developing GI-related symptoms with metformin will be randomized to Psyllium

Criteria 

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.
No Results Posted