Study Uses Combination Intervention to Prevent Diabetes
June 17, 2011
Study Uses Combination Pharmacological Intervention: Metformin Alone & Metformin with Liraglutide to Prevent Diabetes in Post-Pregnancy, Overweight Women with History of Gestational Diabetes
Our new study focuses on preventing the onset of diabetes in overweight women with a history of gestational diabetes who delivered less than a year ago. In a double-blind placebo trial, for the next two years, Woman’s will monitor 150 women in order to determine the effectiveness of two drug combinations in stabilizing sugar and insulin levels and promoting weight loss. The medications are Metformin and Metformin in combination with Liraglutide, a long-acting glucagon-like peptide 1 (GLP-1) derivative administered once daily.
“This study is another step in Woman’s efforts to help women control metabolic problems discovered during pregnancy and stop the process from accelerating to diabetes,” explains study investigator Dr. Karen Elkind-Hirsch, Woman’s Hospital Scientific Director of Research. A diagnosis of gestational diabetes (GDM) usually disappears after pregnancy, but increases a woman’s subsequent risk of developing diabetes. Other studies have concluded that 35%-75% of women with GDM will progress to Type 2 diabetes in two to 10 years.
“For a woman with a history of GDM who is overweight, weight loss can significantly reduce her chance of developing diabetes. By studying a combination, compared to only one medication, we hope to determine if this combination can better promote insulin stabilization and a reduction in body mass index,” says Elkind-Hirsch.
In a double-blind study, neither the participants nor Woman’s researchers will know which medications are distributed. While all patients will receive Metformin, only half of the patients will receive Liraglutide and the others a second placebo medication.
- Metformin decreases the amount of glucose (sugar) absorbed from food and the amount of glucose made by the liver. Metformin also increases the body's response to insulin, a natural substance that controls the amount of glucose in the blood.
- Liraglutide is a synthetic replica of a naturally occurring, long-acting glucagon-like peptide 1 (GLP-1) that stimulates insulin production only when glucose is ingested orally. It also stimulates satiety, thereby decreasing appetite. In its natural form, this peptide is short lived; however, through a daily injection, the synthetic Liraglutide works all day to stabilize blood sugar levels.
Combined Liraglutide and Metformin Therapy in Women with Previous Gestational Diabetes Mellitus will study overweight women who were diagnosed with GDM in their last pregnancy, have not returned to normal metabolic function, and remain overweight with diagnosed insulin problems. Participants must have delivered infants at Woman’s Hospital and had GDM within the past year, be 18-45 years old, and meet all additional study requirements. Participants will be compensated for their time in addition to receiving free medication, clinic visits with the physician, and testing.
GDM, first diagnosed during pregnancy in 2%-14% of women, is characterized by high levels of glucose (sugar) in the blood. Glucose levels are normally controlled by the release of insulin, however, during pregnancy hormonal changes increase all women’s insulin needs, and if the body cannot keep up with the demand, gestational diabetes develops.