Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial.

MedStar author(s):
Citation: Diabetes Care. 42(12):2262-2271, 2019 12.PMID: 31530667Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Diabetes Mellitus, Type 2/dt [Drug Therapy] | *Glucagon-Like Peptides/ad [Administration & Dosage] | *Hypoglycemic Agents/ad [Administration & Dosage] | *Insulin/ad [Administration & Dosage] | *Metformin/ad [Administration & Dosage] | Adult | Body Weight/de [Drug Effects] | Diabetes Mellitus, Type 2/bl [Blood] | Double-Blind Method | Drug Therapy, Combination | Female | Glycated Hemoglobin A/de [Drug Effects] | Humans | Male | Middle Aged | Nausea/ci [Chemically Induced] | Treatment Outcome | Weight Loss/de [Drug Effects]Year: 2019Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006ISSN:
  • 0149-5992
Name of journal: Diabetes careAbstract: CONCLUSIONS: Oral semaglutide was superior to placebo in reducing HbA1c and body weight when added to insulin +/- metformin in patients with type 2 diabetes. The safety profile was consistent with other glucagon-like peptide-1 receptor agonists. Copyright (c) 2019 by the American Diabetes Association.OBJECTIVE: To investigate the efficacy, safety and tolerability of oral semaglutide added to insulin +/- metformin.RESEARCH DESIGN AND METHODS: Patients with type 2 diabetes uncontrolled on insulin, +/- metformin, were randomized to oral semaglutide 3 mg (N=184), 7 mg (N=182), or 14 mg (N=181), or placebo (N=184) in a 52-week, double-blind trial (NCT03021187). Endpoints were change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Two estimands were defined: treatment policy (effect regardless of trial product discontinuation or rescue medication) and trial product (effect assuming trial product continuation without rescue medication) in randomized patients.RESULTS: Oral semaglutide was superior to placebo in reducing HbA1c (estimated treatment differences [ETD] [95% CI]: -0.5% [-0.7, -0.3], -0.9% [-1.1, -0.7], -1.2% [-1.4, -1.0] for 3, 7, and 14 mg, respectively; P<0.001) and body weight (ETD [95% CI]: -0.9 kg [-1.8, -0.0], -2.0 kg [-3.0, -1.0], -3.3 kg [-4.2, -2.3]; P=0.0392 for 3 mg, P<=0.0001 for 7 and 14 mg) at week 26 (treatment policy estimand). Significantly greater, dose-dependent HbA1c, and body weight reductions versus placebo were achieved with oral semaglutide at weeks 26 and 52 (both estimands). The most frequent adverse event with oral semaglutide was nausea (11.4-23.2% of patients vs 7.1% with placebo; mostly mild-to-moderate).All authors: Araki E, Aroda VR, Buse JB, Cariou B, Harris SB, Hoff ST, Pedersen KB, PIONEER 8 investigators, Tarp-Johansen MJ, Zinman BOriginally published: Diabetes Care. 2019 Sep 17Fiscal year: FY2020Digital Object Identifier: Date added to catalog: 2019-10-10
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 31530667 Available 31530667

Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006

CONCLUSIONS: Oral semaglutide was superior to placebo in reducing HbA1c and body weight when added to insulin +/- metformin in patients with type 2 diabetes. The safety profile was consistent with other glucagon-like peptide-1 receptor agonists. Copyright (c) 2019 by the American Diabetes Association.

OBJECTIVE: To investigate the efficacy, safety and tolerability of oral semaglutide added to insulin +/- metformin.

RESEARCH DESIGN AND METHODS: Patients with type 2 diabetes uncontrolled on insulin, +/- metformin, were randomized to oral semaglutide 3 mg (N=184), 7 mg (N=182), or 14 mg (N=181), or placebo (N=184) in a 52-week, double-blind trial (NCT03021187). Endpoints were change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Two estimands were defined: treatment policy (effect regardless of trial product discontinuation or rescue medication) and trial product (effect assuming trial product continuation without rescue medication) in randomized patients.

RESULTS: Oral semaglutide was superior to placebo in reducing HbA1c (estimated treatment differences [ETD] [95% CI]: -0.5% [-0.7, -0.3], -0.9% [-1.1, -0.7], -1.2% [-1.4, -1.0] for 3, 7, and 14 mg, respectively; P<0.001) and body weight (ETD [95% CI]: -0.9 kg [-1.8, -0.0], -2.0 kg [-3.0, -1.0], -3.3 kg [-4.2, -2.3]; P=0.0392 for 3 mg, P<=0.0001 for 7 and 14 mg) at week 26 (treatment policy estimand). Significantly greater, dose-dependent HbA1c, and body weight reductions versus placebo were achieved with oral semaglutide at weeks 26 and 52 (both estimands). The most frequent adverse event with oral semaglutide was nausea (11.4-23.2% of patients vs 7.1% with placebo; mostly mild-to-moderate).

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