Efficacy and Safety of Ertugliflozin in Patients with Overweight and Obesity with Type 2 Diabetes Mellitus

Heymsfield, Steven B.; Raji, Annaswamy; Gallo, Silvina; Liu, Jie; Pong, Annpey; Hannachi, Hakima; Terra, Steven G.

doi:10.1002/oby.22748

Cited by 21Diabetes Treatment and ManagementPharmacology and Obesity TreatmentDiabetes, Cardiovascular Risks, and Lipoproteins

Efficacy and Safety of Ertugliflozin in Patients with Overweight and Obesity with Type 2 Diabetes Mellitus

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Heymsfield, Steven B., Raji, Annaswamy, Gallo, Silvina, Liu, Jie, Pong, Annpey, Hannachi, Hakima, Terra, Steven G.·2020·Obesity

DOI 10.1002/oby.22748PMC PMC7217180

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Abstract

Objective: This study aimed to evaluate ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus. Methods: Data from three placebo‐controlled, randomized, Phase 3 studies were pooled. Patients with baseline BMI ≥ 25 (1,377/1,544; 89%) were assessed with a stratification by BMI subgroup. Results: At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo. For placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively, least squares mean change was 0.1%, −0.8%, and −0.9% for HbA1c and −1.2 kg, −3.1 kg, and −3.2 kg for BW. HbA1c reductions were consistent across BMI subgroups. For ertugliflozin 5 mg and 15 mg, least squares mean change (placebo adjusted) in absolute BW was −1.4 kg and −1.2 kg for BMI 25 to < 30, −1.8 kg and −1.9 kg for BMI 30 to < 35, and −2.5 kg and −2.9 kg for BMI ≥ 35. Percent BW changes were similar across BMI subgroups. Incidence of adverse events was 52.5%, 44.6%, and 50.1% with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively. Conclusions: Meaningful reductions in HbA1c, fasting plasma glucose, BW, and SBP were observed with ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus. Ertugliflozin improved HbA1c and SBP and reduced BW across BMI subgroups. Ertugliflozin was generally well tolerated.

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Previous RCTs reported that selective SGLT2 inhibitors reduce body weight by 1-3 kg in diabetic patients with and without obesity.
“Previous RCTs reported that selective SGLT2 inhibitors, a new class of anti-diabetes drugs, have been shown to reduce body weight (1–3 kg reduction) in diabetic patients with and without obesity [99–102].”
From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [102]

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Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand?
Tak, Y. J., & Lee, S. Y. (2021) · Current Obesity Reports · doi:10.1007/s13679-020-00422-w · Cited by 343 · see citing works
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Authors: Heymsfield, S. B., Raji, A., Gallo, S., Liu, J., Pong, A., Hannachi, H., & Terra, S. G.
Affiliations: Pennington Biomedical Research Center (US)
Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
Pfizer (Germany) (DE)
Pfizer (United States) (US)
Corresponding author: Terra, Steven G.
ORCID: Heymsfield, Steven B.
Raji, Annaswamy
Liu, Jie
Pong, Annpey
Terra, Steven G.
Venue: Obesity
Publisher: Wiley
Published: 2020-03-23
Volume: 28
Issue: 4
Pages: 724-732
ISSN: 1930-7381 (ISSN-L)
1930-739X
DOI: 10.1002/oby.22748
PMC: PMC7217180
OpenAlex: W3012577282
Cited by: 21
References: 41
Citations by year: 2026: 3 · 2025: 3 · 2024: 5 · 2023: 3 · 2022: 3 · 2021: 3 · 2020: 1
FWCI: 1.89
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Obesity (publishedVersion, cc-by-nc-nd)
PubMed Central (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Funders: Merck Sharp and Dohme
Merck
Pfizer
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords: ertugliflozin, type 2 diabetes, overweight, HbA1c, fasting blood glucose, weight loss, systolic blood pressure, adverse events, drug safety, drug efficacy, SGLT2 inhibitors
MeSH terms: Sodium-Glucose Transporter 2 Inhibitors, Diabetes Mellitus, Type 2, Female, Humans, Male, Middle Aged, Obesity, Bridged Bicyclo Compounds, Heterocyclic, Overweight

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Efficacy and Safety of Ertugliflozin in Patients with Overweight and Obesity with Type 2 Diabetes Mellitus

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