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

Pharmalyte Solutions

Status and phase: Begins enrollment in 8 months; Phase 2

Conditions: Hypomagnesemia in Type 2 Diabetic Patients

Treatments: Drug: Placebo Oral Tablet; Drug: Magnesium L-lactate dihydrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03567824

MLD 10-003

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Open label phase

Experimental group

Description:

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

Treatment:

Drug: Magnesium L-lactate dihydrate

Random off phase

Other group

Description:

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

Treatment:

Drug: Magnesium L-lactate dihydrate

Drug: Placebo Oral Tablet