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

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03567824

Enrollment

200

Registered

2018-06-26

Start date

2026-03-01

Completion date

2028-04-30

Last updated

2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypomagnesemia in Type 2 Diabetic Patients

Brief summary

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.

Interventions

DRUGMagnesium L-lactate dihydrate

Magnesium L-lactate dihydrate 10 mEq extended release caplets

DRUGPlacebo Oral Tablet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

The second phase of the study where subjects are randomized to either active or placebo will be blinded to both participant and investigator.

Intervention model description

All subjects will be treated open label for the first 3 months on study, then randomized to receive either active or placebo for an additional 3 months.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Serum Magnesium Concentration	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

Measure	Time frame	Description
Change in Serum Magnesium Concentration.	At 1 and 2 months after the initiation of treatment.	Change from baseline in serum magnesium concentration.
Change in Fasting Blood Glucose	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	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	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	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.

Contacts

Primary ContactSteve F Brandon

sbrandon@niche-inc.com817.421.2777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026