Back to resultsMLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus
Primary Purpose
Hypomagnesemia in Type 2 Diabetic Patients
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Magnesium L-lactate dihydrate
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Hypomagnesemia in Type 2 Diabetic Patients
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Open label phase
Random off phase
Arm Description
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects.
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo
Outcomes
Primary Outcome Measures
Change in Serum Magnesium Concentration
Change from baseline in serum magnesium concentration.
Secondary Outcome Measures
Change in Serum Magnesium Concentration.
Change from baseline in serum magnesium concentration.
Change in Fasting Blood Glucose
Change from baseline in fasting blood glucose.
Change in Insulin Sensitivity
Change from baseline in insulin sensitivity.
Change in Insulin Resistance
Change from baseline in insulin resistance.
Change in HbA1c
Change from baseline in HbA1c.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03567824
Brief Title
MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmalyte Solutions LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypomagnesemia in Type 2 Diabetic Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open label phase
Arm Type
Experimental
Arm Description
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects.
Arm Title
Random off phase
Arm Type
Other
Arm Description
MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo
Intervention Type
Drug
Intervention Name(s)
Magnesium L-lactate dihydrate
Other Intervention Name(s)
MLD10
Intervention Description
Magnesium L-lactate dihydrate 10 mEq extended release caplets
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo will have the same appearance, taste, odor and mode of administration as MLD10.
Primary Outcome Measure Information:
Title
Change in Serum Magnesium Concentration
Description
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 Outcome Measure Information:
Title
Change in Serum Magnesium Concentration.
Description
Change from baseline in serum magnesium concentration.
Time Frame
At 1 and 2 months after the initiation of treatment.
Title
Change in Fasting Blood Glucose
Description
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.
Title
Change in Insulin Sensitivity
Description
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.
Title
Change in Insulin Resistance
Description
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.
Title
Change in HbA1c
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve F Brandon
Phone
817.421.2777
Email
sbrandon@niche-inc.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus
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