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

Hypomagnesemia in Type 2 Diabetic Patients Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03567824
• Other study ID #: MLD 10-003
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2026
• Est. completion date: April 30, 2028

Study information

• Verified date: November 2023
• Source: Pharmalyte Solutions LLC
• Contact: Steve F Brandon
• Phone: 817.421.2777
• Email: sbrandon[@]niche-inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypomagnesemia in Type 2 Diabetic Patients

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pharmalyte Solutions LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Serum Magnesium Concentration.	Change from baseline in serum magnesium concentration.	At 1 and 2 months after the initiation of treatment.
Secondary	Change in Fasting Blood Glucose	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.
Secondary	Change in Insulin Sensitivity	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.
Secondary	Change in Insulin Resistance	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.
Secondary	Change in HbA1c	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.