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Clinical Trial Details

Trial ID: L3394
Source ID: NCT03567824
Associated Drug: Magnesium L-Lactate Dihydrate
Title: MLD10 for the Treatment of Hypomagnesemic Patients With Type 2 Diabetes Mellitus
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Hypomagnesemia in Type 2 Diabetic Patients
Interventions: DRUG: Magnesium L-lactate dihydrate|DRUG: Placebo Oral Tablet
Outcome Measures: Primary: 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. | Secondary: 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., 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.
Sponsor/Collaborators: Sponsor: Pharmalyte Solutions LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2026-03-01
Completion Date: 2028-04-30
Results First Posted:
Last Update Posted: 2023-11-27
Locations:
URL: https://clinicaltrials.gov/show/NCT03567824

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress