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

NCT03567824 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: MLD 10-003
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypomagnesemia in Type 2 Diabetic Patients

Outcome Measures

Primary Outcomes (1)

• Change in Serum Magnesium Concentration

  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 Outcomes (5)

• Change in Serum Magnesium Concentration.

  At 1 and 2 months after the initiation of treatment.

• Change 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

  Three months after the initiation of treatment and then at 3 months after the start of the random off phase.

• Change 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

  Three months after the initiation of treatment and then at 3 months after the start of the random off phase.

Study Arms (2)

Open label phase

EXPERIMENTAL

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

Drug: Magnesium L-lactate dihydrate

Random off phase

OTHER

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

Drug: Magnesium L-lactate dihydrate; Drug: Placebo Oral Tablet

Interventions

Magnesium L-lactate dihydrate DRUG

Magnesium L-lactate dihydrate 10 mEq extended release caplets

Also known as: MLD10

Open label phase; Random off phase

Placebo Oral Tablet DRUG

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

Random off phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pharmalyte Solutions LLC: lead

Central Study Contacts

Steve F Brandon

CONTACT

817.421.2777; sbrandon@niche-inc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The second phase of the study where subjects are randomized to either active or placebo will be blinded to both participant and investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 26, 2018
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: November 27, 2023

Record last verified: 2023-11