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

Phase 2

Not yet recruiting

• Conditions: Hypomagnesemia in Type 2 Diabetic Patients
• Interventions: Drug: Magnesium L-lactate dihydrate; Drug: Placebo Oral Tablet

• Registration Number: NCT03567824
• Lead Sponsor: Pharmalyte Solutions LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-06-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-27
• Study Start: 2026-03-01
• Primary Completion: 2028-04-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open label phase	Magnesium L-lactate dihydrate	MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects.
Random off phase	Magnesium L-lactate dihydrate	MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo
Random off phase	Placebo Oral Tablet	MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo

Primary Outcome Measures

Name	Time	Method
Change in Serum Magnesium Concentration	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.

Secondary Outcome Measures

Name	Time	Method
Change in Serum Magnesium Concentration.	At 1 and 2 months after the initiation of treatment.	Change from baseline in serum magnesium concentration.
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 from baseline in insulin sensitivity.
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 from baseline in insulin resistance.
Change in HbA1c	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.
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 from baseline in fasting blood glucose.