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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label phase | Experimental | MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects. |
|
| Random off phase | Other | MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium L-lactate dihydrate | Drug | Magnesium L-lactate dihydrate 10 mEq extended release caplets |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve F Brandon | Contact | 817.421.2777 | sbrandon@niche-inc.com |
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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.
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The second phase of the study where subjects are randomized to either active or placebo will be blinded to both participant and investigator.
| Placebo Oral Tablet | Drug | Placebo will have the same appearance, taste, odor and mode of administration as MLD10. |
|
| 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. |