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

Phase 2Not Yet RecruitingNCT03567824

Pharmalyte Solutions LLC200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Hypomagnesemia in Type 2 Diabetic Patients

Interventions

Magnesium L-lactate dihydrateDRUG

Magnesium L-lactate dihydrate 10 mEq extended release caplets

Placebo Oral TabletDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Serum Magnesium Concentration

Change from baseline 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.

Secondary Outcomes

Change in Serum Magnesium Concentration.

Change from baseline in serum magnesium concentration.

Time frame: At 1 and 2 months after the initiation of treatment.

Change in Fasting Blood Glucose

Change from baseline 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 in Insulin Sensitivity

Change from baseline 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 in Insulin Resistance

Change from baseline 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 in HbA1c

Change from baseline in HbA1c.

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

Central Contacts

Steve F Brandon

CONTACT

817.421.2777 sbrandon@niche-inc.com

Data from ClinicalTrials.gov

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