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

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.

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.