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MLD10 for Hypomagnesemic Type 2 Diabetes Mellitus Treatment

Study Aim

This phase 2 study aims to evaluate the effectiveness of MLD10 in treating Hypomagnesemic Type 2 Diabetes Mellitus by observing changes in your serum magnesium concentration.

What is being tested

Magnesium L-lactate dihydrate

+ Placebo Oral Tablet

Drug

Who is being recruted

Over 18 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: March 2026

See protocol details

Summary

Principal SponsorPharmalyte Solutions LLC

Study ContactSteve F Brandon

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on Type 2 diabetic patients who have low levels of magnesium in their blood, a condition known as hypomagnesemia. The main goal is to see how well a specific treatment, Magnesium L-Lactate Dihydrate Extended-Release Caplets (MLD10) 10 mEq, taken twice daily, can help manage this condition. This is important because maintaining proper magnesium levels can potentially improve the care and quality of life for people with Type 2 diabetes. During the study, participants will be given MLD10 to take twice a day. The effect of this treatment will be measured by observing changes in the magnesium levels in the blood from the start to the end of the study. The primary outcome of interest is the change in serum magnesium concentration, which will help determine the effectiveness of MLD10 in managing hypomagnesemia in Type 2 diabetic patients.

Official TitleA Phase 2 Open Label Study of Magnesium L-Lactate Dihydrate (MLD10) 10 mEq Extended-Release Caplets Administered BID for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus Followed by a Blinded Random Off Phase

NCT03567824

Principal SponsorPharmalyte Solutions LLC

Study ContactSteve F Brandon

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Females and males with Type 2 diabetes mellitus

Body Mass Index between 18 to 40 kg/m2, inclusive, at Screening

Hypomagnesemia defined as serum magnesium ≤ 1.5 mg/dL at Screening

Females must be non-pregnant, non-lactating, and have a negative serum pregnancy test before enrollment.

1 exclusion criteria prevent from participating

History of clinically significant GI, renal, hepatic, neurologic, hematologic, endocrine other than Type 2 diabetes mellitus, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects.

Group II

MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers