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Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.
Frías, Juan P; Davies, Melanie J; Rosenstock, Julio; Pérez Manghi, Federico C; Fernández Landó, Laura; Bergman, Brandon K; Liu, Bing; Cui, Xuewei; Brown, Katelyn.
  • Frías JP; From the National Research Institute, Los Angeles (J.P.F.); the Diabetes Research Centre, University of Leicester, and the National Institute of Health Research Leicester Biomedical Research Centre - both in Leicester, United Kingdom (M.J.D.); the Dallas Diabetes Research Center at Medical City, Dal
  • Davies MJ; From the National Research Institute, Los Angeles (J.P.F.); the Diabetes Research Centre, University of Leicester, and the National Institute of Health Research Leicester Biomedical Research Centre - both in Leicester, United Kingdom (M.J.D.); the Dallas Diabetes Research Center at Medical City, Dal
  • Rosenstock J; From the National Research Institute, Los Angeles (J.P.F.); the Diabetes Research Centre, University of Leicester, and the National Institute of Health Research Leicester Biomedical Research Centre - both in Leicester, United Kingdom (M.J.D.); the Dallas Diabetes Research Center at Medical City, Dal
  • Pérez Manghi FC; From the National Research Institute, Los Angeles (J.P.F.); the Diabetes Research Centre, University of Leicester, and the National Institute of Health Research Leicester Biomedical Research Centre - both in Leicester, United Kingdom (M.J.D.); the Dallas Diabetes Research Center at Medical City, Dal
  • Fernández Landó L; From the National Research Institute, Los Angeles (J.P.F.); the Diabetes Research Centre, University of Leicester, and the National Institute of Health Research Leicester Biomedical Research Centre - both in Leicester, United Kingdom (M.J.D.); the Dallas Diabetes Research Center at Medical City, Dal
  • Bergman BK; From the National Research Institute, Los Angeles (J.P.F.); the Diabetes Research Centre, University of Leicester, and the National Institute of Health Research Leicester Biomedical Research Centre - both in Leicester, United Kingdom (M.J.D.); the Dallas Diabetes Research Center at Medical City, Dal
  • Liu B; From the National Research Institute, Los Angeles (J.P.F.); the Diabetes Research Centre, University of Leicester, and the National Institute of Health Research Leicester Biomedical Research Centre - both in Leicester, United Kingdom (M.J.D.); the Dallas Diabetes Research Center at Medical City, Dal
  • Cui X; From the National Research Institute, Los Angeles (J.P.F.); the Diabetes Research Centre, University of Leicester, and the National Institute of Health Research Leicester Biomedical Research Centre - both in Leicester, United Kingdom (M.J.D.); the Dallas Diabetes Research Center at Medical City, Dal
  • Brown K; From the National Research Institute, Los Angeles (J.P.F.); the Diabetes Research Centre, University of Leicester, and the National Institute of Health Research Leicester Biomedical Research Centre - both in Leicester, United Kingdom (M.J.D.); the Dallas Diabetes Research Center at Medical City, Dal
N Engl J Med ; 385(6): 503-515, 2021 08 05.
Article in English | MEDLINE | ID: covidwho-2160403
ABSTRACT

BACKGROUND:

Tirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 (GLP-1) receptor agonist that is under development for the treatment of type 2 diabetes. The efficacy and safety of once-weekly tirzepatide as compared with semaglutide, a selective GLP-1 receptor agonist, are unknown.

METHODS:

In an open-label, 40-week, phase 3 trial, we randomly assigned 1879 patients, in a 1111 ratio, to receive tirzepatide at a dose of 5 mg, 10 mg, or 15 mg or semaglutide at a dose of 1 mg. At baseline, the mean glycated hemoglobin level was 8.28%, the mean age 56.6 years, and the mean weight 93.7 kg. The primary end point was the change in the glycated hemoglobin level from baseline to 40 weeks.

RESULTS:

The estimated mean change from baseline in the glycated hemoglobin level was -2.01 percentage points, -2.24 percentage points, and -2.30 percentage points with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and -1.86 percentage points with semaglutide; the estimated differences between the 5-mg, 10-mg, and 15-mg tirzepatide groups and the semaglutide group were -0.15 percentage points (95% confidence interval [CI], -0.28 to -0.03; P = 0.02), -0.39 percentage points (95% CI, -0.51 to -0.26; P<0.001), and -0.45 percentage points (95% CI, -0.57 to -0.32; P<0.001), respectively. Tirzepatide at all doses was noninferior and superior to semaglutide. Reductions in body weight were greater with tirzepatide than with semaglutide (least-squares mean estimated treatment difference, -1.9 kg, -3.6 kg, and -5.5 kg, respectively; P<0.001 for all comparisons). The most common adverse events were gastrointestinal and were primarily mild to moderate in severity in the tirzepatide and semaglutide groups (nausea, 17 to 22% and 18%; diarrhea, 13 to 16% and 12%; and vomiting, 6 to 10% and 8%, respectively). Of the patients who received tirzepatide, hypoglycemia (blood glucose level, <54 mg per deciliter) was reported in 0.6% (5-mg group), 0.2% (10-mg group), and 1.7% (15-mg group); hypoglycemia was reported in 0.4% of those who received semaglutide. Serious adverse events were reported in 5 to 7% of the patients who received tirzepatide and in 3% of those who received semaglutide.

CONCLUSIONS:

In patients with type 2 diabetes, tirzepatide was noninferior and superior to semaglutide with respect to the mean change in the glycated hemoglobin level from baseline to 40 weeks. (Funded by Eli Lilly; SURPASS-2 ClinicalTrials.gov number, NCT03987919.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Gastric Inhibitory Polypeptide / Diabetes Mellitus, Type 2 / Glucagon-Like Peptides / Hypoglycemic Agents Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Female / Humans / Male / Middle aged Language: English Journal: N Engl J Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Gastric Inhibitory Polypeptide / Diabetes Mellitus, Type 2 / Glucagon-Like Peptides / Hypoglycemic Agents Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Female / Humans / Male / Middle aged Language: English Journal: N Engl J Med Year: 2021 Document Type: Article