Clinical Trial Results:
Effect of oral magnesium supplementation on insulin sensitivity in people with type 2 diabetes
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Summary
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EudraCT number |
2021-001243-27 |
Trial protocol |
NL |
Global end of trial date |
15 Nov 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Nov 2023
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First version publication date |
23 Nov 2023
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Other versions |
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Summary report(s) |
Magnesium study published manuscript |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
77108
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
U1111-1264-6218 | ||
Other trial identifiers |
PaNaMa: 111728 | ||
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Sponsors
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Sponsor organisation name |
Radboudumc
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Sponsor organisation address |
Geert Grooteplein Zuid 10, Nijmegen, Netherlands, 6525 GA
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Public contact |
Internal Medicine, Radboudumc, +31 243618819, secretariaatstaf.aig@radboudumc.nl
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Scientific contact |
Internal Medicine, Radboudumc, +31 243618819, secretariaatstaf.aig@radboudumc.nl
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Jun 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Nov 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Nov 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To investigate the effect of oral magnesium supplementation on insulin sensitivity in people with insulin-treated type 2 diabetes mellitus (T2DM) and a low serum magnesium concentration.
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Protection of trial subjects |
Magnesium gluconate has a safe profile and the recruited subjects will receive magnesium in the same way as used in daily clinical care. Possible side effects of magnesium gluconate are gastro-intestinal symptoms like diarrhoea. Their was a weekly telephone consultation with the investigator to monitor possible side effects. The use of venous catheters may cause hematomas or phlebitis which are self-limiting. During the clamp there is a potential risk of developing hypoglycemia, yet this risk is very low because plasma glucose levels are frequently monitored and glucose 20% is continuously infused, the rate of which will be increased when glucose levels tend to fall. In ver 1000 clamps performed to date, severe hypoglycemia has never occurred.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Dec 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 14
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Worldwide total number of subjects |
14
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EEA total number of subjects |
14
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
5
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From 65 to 84 years |
9
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects will be recruited from the outpatient clinic of the Radboud University Medical Center. Patients will be asked to participate by their treating physician. Subjects are also recruited via social media and via advertisements on websites of patient associations. | |||||||||
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Pre-assignment
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Screening details |
A total of 30 participants were screened, 14 of whom were included (14 were excluded because their serum magnesium concentration was too high, 1 because of participation in another study, 1 because of a decreased renal function). First inclusion: 22-2-2022. Last inclusion: 3-8-2022. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Blinding implementation details |
Randomisation to the order of treatment regimens will be performed by the pharmacy department to ensure the double blind study design.
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Magnesium | |||||||||
Arm description |
Treatment with magnesium gluconate for 6 weeks, administered orally as a liquid solution of 50 ml three times a day, resulting in a daily dose of 150 ml (15 mmol magnesium, equivalent to 360 mg). | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Magnesium gluconate oral solution 0.1 mmol/ml
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution in bottle
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Routes of administration |
Oral use
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Dosage and administration details |
50 ml three times a day, resulting in a daily dose of 150 ml (15 mmol magnesium, equivalent to 360 mg)
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Arm title
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Placebo | |||||||||
Arm description |
Treatment with placebo, administered orally as a liquid solution of 50 ml three times a day, resulting in a daily dose of 150 ml. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution in bottle
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Routes of administration |
Oral use
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Dosage and administration details |
50 ml three times a day, resulting in a daily dose of 150 ml.
The placebo IMP fot this trial has the same qualitative composition as the "magnesium gluconate oral solution 0.1 mmol/ml", except magnesium gluconate. Furthermore, the placebo contains NaOH to adjust the pH to 5 (same pH as verum).
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Magnesium
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Reporting group description |
Treatment with magnesium gluconate for 6 weeks, administered orally as a liquid solution of 50 ml three times a day, resulting in a daily dose of 150 ml (15 mmol magnesium, equivalent to 360 mg). | ||
Reporting group title |
Placebo
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Reporting group description |
Treatment with placebo, administered orally as a liquid solution of 50 ml three times a day, resulting in a daily dose of 150 ml. | ||
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End point title |
Change in insulin sensitivity after oral magnesium supplementation measured by the difference in mean glucose infusion rates during the final 30 minutes of a hyperinsulinemic euglycemic glucose clamp | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the final 30 minutes of a hyperinsulinemic euglycemic glucose clamp
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Statistical analysis title |
Multilevel mixed-efects linear regression model | ||||||||||||
Comparison groups |
Magnesium v Placebo
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Number of subjects included in analysis |
28
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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| Notes [1] - It was a cross-over study, so 14 participants were included in the analysis because all participants participated in period 1 and period 2 |
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Adverse events information
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Timeframe for reporting adverse events |
22-02-2022 / 15-11-2022
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.1
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Reporting groups
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Reporting group title |
Magnesium
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Reporting group description |
Treatment with magnesium gluconate for 6 weeks, administered orally as a liquid solution of 50 ml three times a day, resulting in a daily dose of 150 ml (15 mmol magnesium, equivalent to 360 mg). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Treatment with placebo, administered orally as a liquid solution of 50 ml three times a day, resulting in a daily dose of 150 ml. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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28 Apr 2022 |
Inclusion criteria "serum magnesium concentration below or equal to 0.75 mmol/l" changed to "serum magnesium concentration below or equal to 0.79 mmol/l" |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/37922013 |
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