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NCT03567824Not yet recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 27 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
200 (estimated)
First submitted
18 May 2018
Start date
1 Mar 2026
Primary completion date
30 Apr 2028
Lead sponsor
Pharmalyte Solutions LLC
NCT number
NCT03567824

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 200
  • From 1 Mar 2026 to the primary completion date, 30 Apr 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.