Metformin for People With Chronic Kidney Disease

Metformin is the world’s most common diabetes medication and is often referred to as a miracle drug. However, use of metformin in those with chronic kidney disease (CKD) has been controversial due to the potential for a dangerous complication — lactic acidosis. This study investigates a new delivery mechanism for metformin that could make it safer for people with CKD.

Clinical Trials Identifier: NCT04854512

Trial Name: Investigational Study of Delayed Release Metformin (DREAM-T2D)

Diabetes Type: Adults with type 2 diabetes and chronic kidney disease (CKD)

Trial Sponsor: Anji Pharma

What is the trial testing?

This study will evaluate if metformin DR (delayed-release metformin) is safe and effective in participants with type 2 diabetes and varying degrees of kidney function, ranging from normal to stage 3 CKD; the study will enroll about 675 people. The primary endpoint will be the change in A1C over 28 weeks compared with placebo. Additionally, researchers will compare the change in A1C and safety endpoints of metformin DR with metformin IR (immediate-release metformin). 

Why is this trial new and important? 

Metformin is the world’s most common diabetes drug and is used by millions around the world. However, metformin use in those with CKD has been controversial due to concerns about the risk for lactic acidosis, a rare but deadly complication caused by the potential accumulation of metformin in the blood of people with CKD. 

Metformin DR, the drug tested in this study, could provide an innovative solution because of its targeted delivery to the small intestine, which is thought to be the site of much of metformin’s glucose-lowering effects. Without as much metformin entering the bloodstream, there is less systemic exposure and thus hopefully a lower risk for lactic acidosis for those with CKD.

Trial Length: 28 weeks

Trial Locations: This is a multicenter, worldwide study with 87 locations across the United States, Canada, Brazil, and Spain. You can see a list of all participating locations here.

Are you interested?

You may be eligible to participate in this trial if:

• You are 18 years and older with type 2 diabetes

• You have an A1C between 7% and 9.5%

• Have an eGFR value of ≥30 mL/min/1.73 m2 

You can see a full list of inclusion/exclusion criteria here. 

For more information: To learn more, you can contact the Novo Nordisk study team at clinicaltrials@anjipharma.com or call (617) 861-8605.

About the authors

Arvind Sommi

Arvind Sommi joined the diaTribe Foundation in 2021 after graduating with Phi Beta Kappa and honors from the University of Florida where he majored in Biology and minored in Sociology.... Read the full bio »