Short-term therapy with combination dipeptidyl peptidase-4 inhibitor saxagliptin/metformin extended release (XR) is superior to saxagliptin or metformin XR monotherapy in prediabetic women with polycystic ovary syndrome...

Short-term treatment with combination saxagliptin/ metformin XR is superior to either drug alone in terms of clinical and metabolic benefits in patients with PCOS and prediabetic hyperglycemia.


Volume 107, Issue 1, Pages 253-260

Authors:

Karen E. Elkind-Hirsch, Ph.D., Martha S. Paterson, M.D., Ericka L. Seidemann, M.S., Hanh C. Gutowski, R.N.

Abstract:

Objective

To evaluate efficacy with the dipeptidyl peptidase-4 inhibitor saxagliptin (SAXA), metformin extended release (MET), and combination (SAXA-MET) in patients with polycystic ovary syndrome (PCOS) and impaired glucose regulation.

Design

Prospective, randomized, single-blind drug study.

Setting

Outpatient clinic.

Patient(s)

Patients (n = 38) with PCOS (aged 18–42 years) and prediabetic hyperglycemia determined by a 75-gram oral glucose tolerance test.

Intervention(s)

Patients were randomized to SAXA-MET (5 mg/2,000 mg), SAXA (5 mg), or MET (2,000 mg) for 16 weeks.

Main Outcome Measure(s)

Fasting and mean blood glucose, insulin sensitivity, insulin secretion, and insulin secretion-sensitivity index (IS-SI) by oral glucose tolerance tests. Free androgen index and lipid levels, average menstrual interval, and anthropometric measurements (body mass index, waist circumference, and waist/height ratio).

Result(s)

The study was completed by 34 patients. Nineteen patients had normal glucose tolerance: 3 of 12 (25%) on MET; 6 of 11 (55%) on SAXA; and 10 of 11 (91%) on SAXA-MET (SAXA-MET statistically superior to MET) at study completion. Body mass index, waist circumference, waist/height ratio, free androgen index, insulin sensitivity, IS-SI, and menses improved in all groups; however, IS-SI and menstrual regularity were significantly better with SAXA-MET vs. MET treatment. Triglyceride, triglyceride/high-density lipoprotein cholesterol ratio and mean blood glucose significantly declined in the SAXA-MET and SAXA groups only.

Conclusion(s)

This pilot work provides the first evidence regarding the effects of a dipeptidyl peptidase-4 inhibitor alone and in combination with MET in this patient population. Treatment with SAXA-MET was superior to either drug alone in terms of clinical and metabolic benefits in prediabetic patients with PCOS.

Clinical Trial Registration Number

NCT02022007.


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