Study results show that the combination of metformin and glibenclamide is as effective as insulin in achieving glycemic control in women with gestational diabetes and may be a more acceptable and cost effective therapy.
The results are in from a phase 3 trial that addressed glycemic control in patients with gestational diabetes mellitus (GDM).
In many developing countries, insulin injections are not easily accessible to women for treatment during pregnancy, due to lack of resources and funds. As an alternative, a team of researchers aimed to find any outstanding benefits when compared to oral hypoglycemic agents (OHA). Lead author Aisha Wali, FCPS, MBBS, and her colleagues examined the simultaneous use of metformin and glibenclamide. The findings were presented at the American Diabetes Association 75th Scientific Sessions in Boston, MA.
“The combination of these drugs have never been used before and then compared to insulin,” Wali, of Aga Khan University, told MD Magazine.
The clinical trial, conducted between January 2013 and October 2014, included 154 women with gestational diabetes mellitus (GDM) who were less than 33 weeks along in their pregnancy. The participants were randomly split into groups that consisted of 70 women who received OHA and 71 who received insulin arm injections. The authors noted that from the OHA group, 41 of the participants continued taking metformin until they delivered, 24 had to start taking glibenclamide as well, and 5 did not tolerate the metformin so they were switched to glibenclamide.
“The OHA group felt like they could manage the condition and treatment,” Wali explained. “But the injection group was apprehensive since that’s not the standard everywhere.”
The team compared average sugar levels between the groups that were taken at the start of the study, 15 days before delivery, and post-delivery using dose measurements and glucose meter memory information. Upon evaluation of glycemic control the data revealed that when rated as uncontrolled, satisfactory, or excellent, the majority of patients in both groups scored as satisfactory.
“We concluded that combination of metformin and glibenclamide is as effective as insulin in achieving glycemic control in women with GDM and is a more acceptable and cost effective therapy,” the team wrote.
Wali explained that the OHA group had a slightly higher outcome of hyperglycemic events, but it was not significant. Both the OHA and insulin treatments have their own sets of pros and cons which make future studies consisting of larger participant pools an important next step.