Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial. Key end points were change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Two estimands addressed efficacy-related questions: treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product without rescue medication) in all randomized patients. RESULTS: Four hundred (97.1%) patients in the oral semaglutide group and 387 (94.4%) in the empagliflozin group completed the trial. Oral semaglutide provided superior reductions in HbA1c versus empagliflozin at week 26 (treatment policy -1.3% vs. -0.9% [-14 vs. -9 mmol/mol], estimated treatment difference [ETD] -0.4% [95% CI -0.6, -0.3] [-5 mmol/mol (-6, -3)]; P < 0.0001). The treatment difference in HbA1c significantly favored oral semaglutide at week 26 for the trial product estimand (-1.4% vs. -0.9% [-15 vs. -9 mmol/mol], ETD -0.5% [95% CI -0.7, -0.4] [-6 mmol/mol (-7, -5)]; P < 0.0001) and at week 52 for both estimands (P < 0.0001). Superior weight loss was not confirmed at week 26 (treatment policy), but oral semaglutide was significantly better than empagliflozin at week 52 (trial product -4.7 vs. -3.8 kg; P = 0.0114). Gastrointestinal adverse events were more common with oral semaglutide. CONCLUSIONS:
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Authors | Helena W Rodbard, Julio Rosenstock, Luis H Canani, Chaicharn Deerochanawong, Janusz Gumprecht, Søren Østergaard Lindberg, Ildiko Lingvay, Anette Luther Søndergaard, Marianne Bach Treppendahl, Eduard Montanya, PIONEER 2 Investigators |
Journal | Diabetes care
(Diabetes Care)
Vol. 42
Issue 12
Pg. 2272-2281
(12 2019)
ISSN: 1935-5548 [Electronic] United States |
PMID | 31530666
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2019 by the American Diabetes Association. |
Chemical References |
- Benzhydryl Compounds
- Glucosides
- Glycated Hemoglobin A
- Hypoglycemic Agents
- hemoglobin A1c protein, human
- semaglutide
- Glucagon-Like Peptides
- Metformin
- empagliflozin
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Topics |
- Administration, Oral
- Adult
- Benzhydryl Compounds
(administration & dosage)
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Glucagon-Like Peptides
(administration & dosage)
- Glucosides
(administration & dosage)
- Glycated Hemoglobin
(drug effects)
- Humans
- Hypoglycemic Agents
(administration & dosage)
- Male
- Metformin
(administration & dosage)
- Middle Aged
- Treatment Outcome
- Weight Loss
(drug effects)
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