TY  - BOOK
AU  - Aroda, Vanita R
TI  - PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes
SN  - 0149-5992
PY  - 2019///
KW  - *Diabetes Mellitus, Type 2/dt [Drug Therapy]
KW  - *Glucagon-Like Peptides/ad [Administration & Dosage]
KW  - *Hypoglycemic Agents/ad [Administration & Dosage]
KW  - Administration, Oral
KW  - Adult
KW  - Diabetes Mellitus, Type 2/bl [Blood]
KW  - Diet
KW  - Double-Blind Method
KW  - Exercise
KW  - Female
KW  - Glycated Hemoglobin A/de [Drug Effects]
KW  - Humans
KW  - Male
KW  - Middle Aged
KW  - Weight Loss/de [Drug Effects]
KW  - MedStar Health Research Institute
KW  - Journal Article
N2  - CONCLUSIONS: In patients with type 2 diabetes, oral semaglutide monotherapy demonstrated superior and clinically relevant improvements in HbA1c (all doses) and body weight loss (14 mg dose) versus placebo, with a safety profile consistent with other GLP-1 receptor agonists. Copyright (c) 2019 by the American Diabetes Association; OBJECTIVE: This trial compared the efficacy and safety of the first oral glucagon-like peptide 1 (GLP-1) receptor agonist, oral semaglutide, as monotherapy with placebo in patients with type 2 diabetes managed by diet and exercise alone. Two estimands addressed two efficacy-related questions: a treatment policy estimand (regardless of trial product discontinuation or rescue medication use) and a trial product estimand (on trial product without rescue medication use) in all randomized patients; RESEARCH DESIGN AND METHODS: This was a 26-week, phase 3a, randomized, double-blind, placebo-controlled, parallel-group trial conducted in 93 sites in nine countries. Adults with type 2 diabetes insufficiently controlled with diet and exercise were randomized (1:1:1:1) to once-daily oral semaglutide 3 mg, 7 mg, 14 mg, or placebo. The primary end point was change from baseline to week 26 in HbA1c. The confirmatory secondary end point was change from baseline to week 26 in body weight; RESULTS: In the 703 patients randomized (mean age 55 years, 50.8% male, and mean baseline HbA1c 8.0% [64 mmol/mol]), oral semaglutide reduced HbA1c (placebo-adjusted treatment differences at week 26: treatment policy estimand, -0.6% [3 mg], -0.9% [7 mg], and -1.1% [14 mg]; trial product estimand, -0.7% [3 mg], -1.2% [7 mg], and -1.4% [14 mg]; P < 0.001 for all) and body weight (treatment policy, -0.1 kg [3 mg], -0.9 kg [7 mg], and -2.3 kg [14 mg, P < 0.001]; trial product, -0.2 kg [3 mg], -1.0 kg [7 mg, P = 0.01], and -2.6 kg [14 mg, P < 0.001]). Mild-to-moderate transient gastrointestinal events were the most common adverse events with oral semaglutide. Trial product discontinuations occurred in 2.3-7.4% with oral semaglutide and 2.2% with placebo
UR  - https://dx.doi.org/10.2337/dc19-0749
ER  -