SHORT-TERM SITAGLIPTIN-METFORMIN THERAPY IS MORE EFFECTIVE THAN METFORMIN OR PLACEBO IN PRIOR GESTATIONAL DIABETIC WOMEN WITH IMPAIRED GLUCOSE REGULATION.

OBJECTIVE

Our pilot study examined the effectiveness of sitagliptin-metformin (SITA-MET), metformin (MET), and placebo (P) therapy on fasting and post-glucose challenge glucose levels in postpartum women with prior gestational diabetes mellitus (GDM) and impaired glucose regulation.

METHODS

Prediabetic women (N = 36, age 18 to 42 years) with recent GDM were randomized to P (one pill twice a day), MET (1,000 mg twice a day), or SITA-MET (50 mg SITA, 1,000 mg MET twice a day) for 16 weeks in a single-blind fashion. An individualized diet and exercise plan were provided to all participants. At baseline and 16 weeks, oral glucose tolerance tests were performed to assess glycemia, mean blood glucose (MBG), and calculate insulin sensitivity (IS) and secretion (SI) indexes. Lipid profile, thyroid-stimulating hormone level, and pregnancy test were performed in the baseline sample.

RESULTS

Thirty-three (92%) participants completed the study. At study end, 15 participants had normal glycemia (SITA-MET vs. MET, P; P = .035). MBG, IS, IS-SI index, and waist to height ratio were significantly improved with SITA-MET compared with MET and P treatment. SITAMET therapy was more effective in lowering body mass index and waist circumference compared to P treatment.

CONCLUSION

Our pilot study is the first to evaluate the use of a dipeptidyl peptidase 4 inhibitor combined with MET in glucose-impaired women with a history of GDM. In this investigation, combination SITA-MET was found to be superior to MET and P in improving glycemia and metabolic measures in this prediabetic population.

ABBREVIATIONS: BID = twice a day; BMI = body mass index; BP = blood pressure; BW = body weight; CHOL = cholesterol; DI = disposition index; DM = diabetes mellitus; DPP-4i = dipeptidyl peptidase 4 inhibitor; FBG = fasting blood glucose; GDM = gestational diabetes mellitus; GLP-1 = glucagon-like peptide 1; HDL-C = high-density-lipoprotein cholesterol; HOMA-IR = homeostasis model assessment of insulin resistance; IGI = insulinogenic index; IGR = impaired glucose regulation; IGT = impaired glucose tolerance; IR = insulin resistance; IS = insulin sensitivity; LDL-C = low-density-lipoprotein cholesterol; MBG = mean blood glucose; MET = metformin; OGTT = oral glucose tolerance test; P = placebo; SI = insulin secretion; SIOGTT = Matsuda's insulin sensitivity index; TRG = triglycerides; WC = waist circumference; WHR = waist to hip ratio; WHtR = waist to height ratio.