CClinicalTrials.gg
Sign In
Not yet recruitingNCT03567824Updated Nov 27, 2023

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

A Phase 2 interventional study of Magnesium L-lactate dihydrate and Placebo Oral Tablet in Hypomagnesemia in Type 2 Diabetic Patients, sponsored by Pharmalyte Solutions LLC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.

Sponsored by Pharmalyte Solutions LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypomagnesemia in Type 2 Diabetic Patients
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 200 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Pharmalyte Solutions LLC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Open label phase

    MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects.

    Drug: Magnesium L-lactate dihydrate

  • Other
    Random off phase

    MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo

    Drug: Magnesium L-lactate dihydrate · Drug: Placebo Oral Tablet

Interventions

  • DrugMagnesium L-lactate dihydrate

    Magnesium L-lactate dihydrate 10 mEq extended release caplets

    Also known as: MLD10

  • DrugPlacebo Oral Tablet

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

06

What researchers measure

Primary outcomes

  1. 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

  1. Change in Serum Magnesium Concentration.

    Change from baseline in serum magnesium concentration.

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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03567824
Lead sponsor
Pharmalyte Solutions LLC
Responsible party
Sponsor
First posted
Jun 26, 2018
Start date
Mar 1, 2026 (estimated)
Primary completion
Apr 30, 2028 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Nov 27, 2023

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus→

Other studies from this sponsor

Pharmalyte Solutions LLC

Start the discussion