2023-11-21 17:21:35
Metformin as a promising alternative for gestational diabetes
Injecting insulin is never pleasant – especially when you are faced with it for the first time during pregnancy. Could metformin be an injection-free alternative for gestational diabetes?
Metformin – what potential does this classic still have? The oral antidiabetic drug is the longest and most frequently prescribed drug for the treatment of type 2 diabetes that does not require insulin. It would also be desirable as a “therapy without a needle” for the treatment of gestational diabetes. Expectant mothers in Germany and around the world are suffering from this more and more often.
Metformin would have a number of advantages. The drug is cheaper than insulin, the current gold standard for treating gestational diabetes. The fact that it can be taken orally instead of an insulin injection would also speak for this. Metformin is also more available than insulin in many countries outside of Europe. Low-income states often experience the largest increases in the number of patients with gestational diabetes.
Doctors and researchers have been discussing the use of the active ingredient in gestational diabetes for many years, with contradictory results so far. Studies could not prove a significant benefit – or provided evidence of undesirable effects.
Off-label use under “strict indications”
There are numerous references to metformin in the 2018 S3 guidelines for the treatment of gestational diabetes. The authors write that the drug is not approved in Germany for the treatment of gestational diabetes. However, if the indication is “strict” and the pregnant woman is informed accordingly, it can be prescribed as part of a therapeutic trial.
Studies in the past have shown that metformin therapy is not inferior to standard insulin therapy. The MiG (Metformin in Gestational Diabetes) study included 751 women with gestational diabetes mellitus between 20 and 33 weeks of pregnancy. They were randomly assigned to initially receive metformin (with additional insulin if necessary) or insulin. The primary outcome was a composite of neonatal hypoglycemia, respiratory distress, need for phototherapy, birth trauma, 5-minute Apgar score less than 7, or preterm birth.
The authors cited the rate of such events as 32.0% in the metformin group versus 32.2% in the insulin group: no significant difference. More women in the metformin group than in the insulin group reported that they would choose to receive their assigned treatment again (76.6% versus 27.2%). A meta-analysis confirms the safety of the therapy compared to insulin.
But metformin continues to stubbornly elude all attempts to make significant statements about its benefits. Reviews of the literature provide a diffuse picture. What now?
New study design – new insights?
A large randomized study by Prof. Fidelma Dunne from the University of Galway and colleagues provides new impetus. Dunne recently presented key results at the congress of the European Association for the Study of Diabetes (EASD). Unlike many studies, pregnant women with gestational diabetes were given either placebo or metformin (maximum dose 2,500 mg) immediately after diagnosis.
As for the secondary clinical results, Dunne was quite satisfied. Their working group was able to show that significantly fewer women needed insulin with metformin than without (38.4% versus 51.1%). The previously observed lower weight gain among expectant mothers was also evident here. Patients also benefited from better control of blood sugar levels. According to their own statements, they were mostly quite satisfied with the oral therapy.
However, the scientists found lower mean birth weight and lower crown-heel length significantly more often among the children in the metformin group. Significantly fewer children had a birth weight of more than 4.0 kg. The authors believe that this fact needs to be further observed and, above all, examined in long-term studies.
Conclusion: Waiting for more data
Overall, they come to the conclusion that metformin as a therapy for gestational diabetes shows numerous clinically relevant positive results, but that there are still just as many questions unanswered.
Further – quite promising – research on the topic will be necessary before metformin becomes fully accepted as a first-line therapy for gestational diabetes.]
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