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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03567824
Recruitment Status : Unknown
Verified March 2020 by Pharmalyte Solutions LLC.
Recruitment status was:  Not yet recruiting
First Posted : June 26, 2018
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Pharmalyte Solutions LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypomagnesemia in Type 2 Diabetic Patients Drug: Magnesium L-lactate dihydrate Drug: Placebo Oral Tablet Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: The second phase of the study where subjects are randomized to either active or placebo will be blinded to both participant and investigator.
Primary Purpose: Treatment
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
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : January 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Open label phase
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects.
 Drug: Magnesium L-lactate dihydrate
Magnesium L-lactate dihydrate 10 mEq extended release caplets
Other Name: MLD10
Random off phase
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo
 Drug: Magnesium L-lactate dihydrate
Magnesium L-lactate dihydrate 10 mEq extended release caplets
Other Name: MLD10

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


Outcome Measures
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Primary Outcome Measures :
  1. Change 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. ]
    Change from baseline in serum magnesium concentration.


Secondary Outcome Measures :
  1. Change in Serum Magnesium Concentration. [ Time Frame: At 1 and 2 months after the initiation of treatment. ]
    Change from baseline in serum magnesium concentration.

  2. Change 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 from baseline in fasting blood glucose.

  3. Change 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 from baseline in insulin sensitivity.

  4. Change 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 from baseline in insulin resistance.

  5. Change in HbA1c [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567824


Contacts
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Contact: Steve F Brandon 817.421.2777 sbrandon@niche-inc.com

Sponsors and Collaborators
Pharmalyte Solutions LLC
More Information
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Responsible Party: Pharmalyte Solutions LLC
ClinicalTrials.gov Identifier: NCT03567824    
Other Study ID Numbers: MLD 10-003
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases