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- Title
Exenatide, Metformin, or Both for Prediabetes in PCOS: A Randomized, Open-label, Parallel-group Controlled Study.
- Authors
Tao Tao; Yi Zhang; Yu-Chen Zhu; Jia-Rong Fu; Yu-Ying Wang; Jie Cai; Jing-Yu Ma; Yu Xu; Yi-Ning Gao; Yun Sun; WuQiang Fan; Wei Liu; Tao, Tao; Zhang, Yi; Zhu, Yu-Chen; Fu, Jia-Rong; Wang, Yu-Ying; Cai, Jie; Ma, Jing-Yu; Xu, Yu
- Abstract
<bold>Context: </bold>Up to 40% of patients with polycystic ovary syndrome (PCOS) have prediabetes; an optimal pharmacotherapy regimen for diabetes prevention in PCOS is yet to be established.<bold>Objective: </bold>To evaluate clinical efficacy of exenatide (EX), metformin (MET), or combination (COM) for prediabetes in PCOS.<bold>Design: </bold>Randomized, open-label, parallel-group controlled trial.<bold>Setting: </bold>Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine.<bold>Patients: </bold>PCOS with prediabetes (fasting plasma glucose 5.6-6.9 mmol/L and/or 2 hour post glucose 7.8-11.0 mmol/L on oral glucose tolerance test [OGTT]). A total of 150 out of 183 eligible enrollees completed the study.<bold>Intervention: </bold>EX (10-20μg daily), MET (1500-2000 mg daily), or COM (EX plus MET) for 12 weeks.<bold>Main Outcome Measures: </bold>Sustained remission rate of prediabetes (primary endpoint, a normal OGTT after 12 weeks of treatment followed by 12 weeks of washout on no drug treatment) along with anthropometric, hormonal, metabolic, and pancreatic β-cell function parameters (secondary endpoints) and potential mechanisms were assessed.<bold>Results: </bold>Impaired glucose tolerance was found the dominant prediabetes phenotype. Overall sustained prediabetes remission rate was 50.7%. Remission rate of COM group (64%, 32/50) or EX group (56%, 28/50) was significantly higher than that of the MET group (32%, 16/50) (P = .003 and .027, respectively). EX was associated with superior suppression of 2-hour glucose increment in OGTT. A 2-step hyperglycemic clamp study revealed that EX had led to higher postprandial insulin secretion than MET, potentially explaining the higher remission rate.<bold>Conclusions: </bold>Compared with MET monotherapy, EX or COM achieved higher rate of remission of prediabetes among PCOS patients by improving postprandial insulin secretion.
- Subjects
CHINA; PREDIABETIC state; GLUCAGON-like peptide-1 agonists; INSULIN; EXENATIDE; ENDOPLASMIC reticulum; METFORMIN; GLUCAGON-like peptide 1; TYPE 2 diabetes; OBESITY complications; GLUCOSE intolerance; OBESITY; RESEARCH; POLYCYSTIC ovary syndrome; COMBINATION drug therapy; RESEARCH methodology; INGESTION; BLOOD sugar; HYPOGLYCEMIC agents; MEDICAL cooperation; EVALUATION research; TREATMENT effectiveness; COMPARATIVE studies; RANDOMIZED controlled trials; RESEARCH funding; DISEASE complications
- Publication
Journal of Clinical Endocrinology & Metabolism, 2021, Vol 106, Issue 3, pe1420
- ISSN
0021-972X
- Publication type
journal article
- DOI
10.1210/clinem/dgaa692