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NCT Number: NCT03567824

MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus

To determine the effect of MLD10 (magnesium L-lactate dihydrate extended-release caplets) 10 mEq BID on serum magnesium in Type 2 diabetic patients with hypomagnesemia.

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Key information

Conditions

Hypomagnesemia in Type 2 Diabetic Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Magnesium L-lactate dihydrate

Drug

Magnesium L-lactate dihydrate 10 mEq extended release caplets

Other names: MLD10

Placebo oral tablet

Drug

Placebo will have the same appearance, taste, odor and mode of administration as MLD10.

Primary outcomes

Change in Serum Magnesium Concentration

Time frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.

Change from baseline in serum magnesium concentration.

Secondary outcomes

Change in Serum Magnesium Concentration.

Time frame: At 1 and 2 months after the initiation of treatment.

Change from baseline in serum magnesium concentration.
Change in Fasting Blood Glucose

Time frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.

Change from baseline in fasting blood glucose.
Change in Insulin Sensitivity

Time frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.

Change from baseline in insulin sensitivity.
Change in Insulin Resistance

Time frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.

Change from baseline in insulin resistance.
Change in HbA1c

Time frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.

Change from baseline in HbA1c.

Study contacts

Contact information is provided by the study sponsor or research team.

Steve F Brandon

CONTACT

[email protected]

817.421.2777

Sponsors and collaborators

Lead sponsor

Pharmalyte Solutions LLC

Industry

Registry information

Official study title

A 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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 26, 2018
Registry last updated: Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.