Liraglutide treatment for the prevention of glucose tolerance deterioration in women with prior gestational diabetes mellitus: A 52‐week randomized controlled clinical trial

Author:

Foghsgaard Signe123ORCID,Vedtofte Louise13ORCID,Andersen Emilie S.13ORCID,Bahne Emilie13,Andreasen Camilla13,Sørensen Anne L.4,Forman Julie L.4ORCID,Mathiesen Elisabeth R.56ORCID,Svare Jens A.2,Clausen Tine D.7,Damm Peter57,Holst Jens J.89ORCID,Knop Filip K.1359ORCID,Vilsbøll Tina135ORCID

Affiliation:

1. Clinical Research, Steno Diabetes Center Copenhagen University of Copenhagen Herlev Denmark

2. Department of Gynaecology and Obstetrics, Herlev Hospital University of Copenhagen Herlev Denmark

3. Center for Clinical Metabolic Research, Gentofte Hospital University of Copenhagen Hellerup Denmark

4. Department of Public Health, Section of Biostatistics University of Copenhagen Copenhagen Denmark

5. Department of Clinical Medicine, Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

6. Center for Pregnant Women with Diabetes, Department of Endocrinology, Rigshospitalet University of Copenhagen Copenhagen Denmark

7. Center for Pregnant Women with Diabetes, Department of Obstetrics, Rigshospitalet University of Copenhagen Copenhagen Denmark

8. Department of Biomedical Sciences, Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

9. Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

Abstract

AbstractAimWe investigated the effect of 52‐week treatment with liraglutide, a glucagon‐like peptide 1 receptor agonist, on glucose tolerance and incretin effect in women with previous gestational diabetes mellitus (pGDM).Materials and MethodsWomen with overweight/obesity and pGDM were randomized to once daily subcutaneous liraglutide 1.8 mg or placebo for 52 weeks. Participants underwent oral glucose tolerance test (OGTT) and isoglycaemic intravenous glucose infusion at baseline and at 52 weeks, and an additional OGTT after the drug wash‐out.ResultsIn total, 104 women [age: mean ± SD, 38 ± 5 years; fasting plasma glucose (FPG): 5.5 ± 0.4 mmol/L; glycated haemoglobin (HbA1c): 33 ± 4 mmol/mol, bodyweight: 88.2 ± 14.8 kg, body mass index: 31.1 ± 4.3 kg/m2] were assigned to liraglutide (n = 49) or placebo (n = 55). Estimated treatment difference (ETD) for area under curve during OGTT was −173 (95% confidence interval −250 to −97) mmol/L × min, p < .0001, but after wash‐out the difference disappeared [ETD 58 (−30 to 146) mmol/L × min, p = .536]. Liraglutide reduced FPG [ETD −0.2 (−0.4 to −0.1) mmol/L, p = .018], HbA1c [−2.2 (−3.5 to −0.8) mmol/mol, p = .018] and bodyweight [−3.9 (−6.2 to −1.6) kg, p = .012]. No change in the incretin effect was observed. The number of women with prediabetes was reduced from 64% to 10% with liraglutide vs. 50% with placebo [adjusted odds ratio 0.10 (0.03‐0.32), p = .002].ConclusionsTreatment with liraglutide for 52 weeks improved glucose tolerance, FPG, HbA1c and bodyweight in women with overweight/obesity and pGDM. Progression to prediabetes while on drug was markedly reduced, but after a 1‐week drug wash‐out, the effect was lost.

Funder

Aase og Ejnar Danielsens Fond

Danish Diabetes and Endocrine Academy

Fonden til Lægevidenskabens Fremme

Novo Nordisk Fonden

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

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