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

NCT ID: NCT03567824

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypomagnesemia in Type 2 Diabetic Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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Open label phase

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

Group Type EXPERIMENTAL

Magnesium L-lactate dihydrate

Intervention Type DRUG

Magnesium L-lactate dihydrate 10 mEq extended release caplets

Random off phase

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

Group Type OTHER

Magnesium L-lactate dihydrate

Intervention Type DRUG

Magnesium L-lactate dihydrate 10 mEq extended release caplets

Placebo Oral Tablet

Intervention Type DRUG

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

Interventions

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Magnesium L-lactate dihydrate

Magnesium L-lactate dihydrate 10 mEq extended release caplets

Intervention Type DRUG

Placebo Oral Tablet

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

Intervention Type DRUG

Other Intervention Names

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MLD10

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmalyte Solutions LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Steve F Brandon

Role: CONTACT

[email protected]
817.421.2777

Other Identifiers

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MLD 10-003

Identifier Type: -

Identifier Source: org_study_id