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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypomagnesemia in Type 2 Diabetic Patients

Intervention / Treatment
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* Drug: Magnesium L-lactate dihydrate
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Magnesium Concentration. | Change from baseline in serum magnesium concentration. | At 1 and 2 months after the initiation of treatment. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |