PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes

Jun 13, 2019Diabetes care

Oral Semaglutide Alone Compared to Placebo for Safety and Effectiveness in Type 2 Diabetes

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Abstract

In a trial of 703 patients, oral semaglutide reduced HbA1c by up to 1.4% compared to placebo after 26 weeks.

Oral semaglutide showed a placebo-adjusted reduction in HbA1c of -0.6% for the 3 mg dose, -0.9% for the 7 mg dose, and -1.1% for the 14 mg dose.
Body weight loss was also observed, with reductions of -0.1 kg for the 3 mg dose, -0.9 kg for the 7 mg dose, and -2.3 kg for the 14 mg dose compared to placebo.
The most common adverse events associated with oral semaglutide were mild-to-moderate gastrointestinal issues.
Trial product discontinuations were reported in 2.3-7.4% of patients taking oral semaglutide and 2.2% for those on placebo.
Oral semaglutide monotherapy may offer significant improvements in diabetes management compared to placebo.

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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 HbA. The confirmatory secondary end point was change from baseline to week 26 in body weight. 1c

RESULTS: In the 703 patients randomized (mean age 55 years, 50.8% male, and mean baseline HbA8.0% [64 mmol/mol]), oral semaglutide reduced HbA(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];< 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,< 0.001]; trial product, -0.2 kg [3 mg], -1.0 kg [7 mg,= 0.01], and -2.6 kg [14 mg,< 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. 1c1c P P P P

CONCLUSIONS: In patients with type 2 diabetes, oral semaglutide monotherapy demonstrated superior and clinically relevant improvements in HbA(all doses) and body weight loss (14 mg dose) versus placebo, with a safety profile consistent with other GLP-1 receptor agonists. 1c

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PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes

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