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

November 22, 2023 updated by: Pharmalyte Solutions LLC

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open label phase
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects.
Drug: Magnesium L-lactate dihydrate
Magnesium L-lactate dihydrate 10 mEq extended release caplets
Other Names:
  • MLD10
Other: Random off phase
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo
Drug: Magnesium L-lactate dihydrate
Magnesium L-lactate dihydrate 10 mEq extended release caplets
Other Names:
  • MLD10
Drug: Placebo Oral Tablet
Placebo will have the same appearance, taste, odor and mode of administration as MLD10.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Magnesium Concentration
Time Frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Change from baseline in serum magnesium concentration.
Three months after the initiation of treatment and then at 3 months after the start of the random off phase.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Magnesium Concentration.
Time Frame: At 1 and 2 months after the initiation of treatment.
Change from baseline in serum magnesium concentration.
At 1 and 2 months after the initiation of treatment.
Change in Fasting Blood Glucose
Time Frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Change from baseline in fasting blood glucose.
Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Change in Insulin Sensitivity
Time Frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Change from baseline in insulin sensitivity.
Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Change in Insulin Resistance
Time Frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Change from baseline in insulin resistance.
Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Change in HbA1c
Time Frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Change from baseline in HbA1c.
Three months after the initiation of treatment and then at 3 months after the start of the random off phase.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmalyte Solutions LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLD 10-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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