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MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus
Sponsor: Pharmalyte Solutions LLC
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.
Official 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-03-01
Completion Date
2028-04-30
Last Updated
2023-11-27
Healthy Volunteers
No
Interventions
Magnesium L-lactate dihydrate
Magnesium L-lactate dihydrate 10 mEq extended release caplets
Placebo Oral Tablet
Placebo will have the same appearance, taste, odor and mode of administration as MLD10.