Hypomagnesemia in Type 2 Diabetic PatientsPhase 2NCT03567824
MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing Magnesium L-lactate dihydrate in people with Hypomagnesemia in Type 2 Diabetic Patients, run by Pharmalyte Solutions LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypomagnesemia in Type 2 Diabetic Patients
- What is being tested?
- Magnesium L-lactate dihydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of clinically significant GI, renal, hepatic, neurologic, hematologic, endocrine other than Type 2 diabetes mellitus, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Magnesium L-lactate dihydrate, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium L-lactate dihydrateDrug
Also called MLD10
Magnesium L-lactate dihydrate 10 mEq extended release caplets
Placebo Oral TabletDrug
Placebo will have the same appearance, taste, odor and mode of administration as MLD10.
| Study group | Role | What they receive |
|---|---|---|
| Open label phase | Experimental | MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects. Receives: Drug: Magnesium L-lactate dihydrate |
| Random off phase | Other | MLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo Receives: Drug: Magnesium L-lactate dihydrate; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Magnesium Concentration
Change from baseline in serum magnesium concentration.
Measured: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Secondary outcomes (5)
Change in Serum Magnesium Concentration.
Change from baseline in serum magnesium concentration.
Measured: At 1 and 2 months after the initiation of treatment.
Change in Fasting Blood Glucose
Change from baseline in fasting blood glucose.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Mar 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypomagnesemia in Type 2 Diabetic PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmalyte Solutions LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567824
- Sponsor's protocol ID
- MLD 10-003
- Status last verified
- Nov 2023
- First submitted
- 18 May 2018
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03567824
- Acronym / sponsor ID
- MLD 10-003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pharmalyte Solutions LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open label phase | Experimental | Drug: Magnesium L-lactate dihydrateMLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months, all subjects. |
| Random off phase | Other | Drug: Magnesium L-lactate dihydrate, Drug: Placebo Oral TabletMLD10 (magnesium l-lactate dihydrate) 10mEq extended release caplets BID for three months or Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- History of clinically significant GI, renal, hepatic, neurologic, hematologic, endocrine other than Type 2 diabetes mellitus, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium L-lactate dihydrateAlso: MLD10Magnesium L-lactate dihydrate 10 mEq extended release caplets | Drug | Open label phase, Random off phase |
| Placebo Oral TabletPlacebo will have the same appearance, taste, odor and mode of administration as MLD10. | Drug | Random off phase |
Primary outcome
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.
5 secondary outcomes
Change in Serum Magnesium Concentration.
Time frame: At 1 and 2 months after the initiation of treatment.
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 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 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 in HbA1c
Time frame: Three months after the initiation of treatment and then at 3 months after the start of the random off phase.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium L-lactate dihydrate in people with Hypomagnesemia in Type 2 Diabetic Patients, run by Pharmalyte Solutions LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steve F Brandon (817.421.2777, sbrandon@niche-inc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.