Efficacy and tolerability of tirzepatide, a dual glucose‐dependent insulinotropic peptide and glucagon‐like peptide‐1 receptor agonist in patients with type 2 diabetes: A 12‐week, randomized, double‐blind, placebo‐controlled study to evaluate different dose‐escalation regimens

Autor: Axel Haupt, Xuewei Cui, Michael A. Nauck, Shweta Urva, Joanna Van, Zvonko Milicevic, Deborah A. Robins, Ross Bray, Juan P. Frias, Charles Benson
Rok vydání: 2020
Předmět:
Male
medicine.medical_specialty
Side effect
Nausea
Endocrinology
Diabetes and Metabolism
Glucagon-Like Peptides
Placebo-controlled study
030209 endocrinology & metabolism
Gastric Inhibitory Polypeptide
glucagon‐like peptide‐1 analogue
Type 2 diabetes
glucose‐dependent insulinotropic peptide
030204 cardiovascular system & hematology
Placebo
Gastroenterology
Glucagon-Like Peptide-1 Receptor
03 medical and health sciences
0302 clinical medicine
Endocrinology
Double-Blind Method
Internal medicine
randomized trial
Internal Medicine
medicine
Humans
Hypoglycemic Agents
Adverse effect
Glucagon-like peptide 1 receptor
Aged
Glycated Hemoglobin
antidiabetic drug
business.industry
Original Articles
Middle Aged
medicine.disease
Treatment Outcome
Diabetes Mellitus
Type 2
Tolerability
Original Article
incretin therapy
type 2 diabetes
medicine.symptom
business
Zdroj: Diabetes, Obesity & Metabolism
ISSN: 1463-1326
1462-8902
Popis: Aim To assess the efficacy and tolerability of tirzepatide treatment using three different dose‐escalation regimens in patients with type 2 diabetes. Materials and Methods In this double‐blind, placebo‐controlled study, patients were randomized (1:1:1:1) to receive either once‐weekly subcutaneous tirzepatide or placebo. The tirzepatide dose groups and dose‐escalation regimens were: 12 mg (4 mg weeks 0–3; 8 mg weeks 4–7; 12 mg weeks 8–11), 15 mg‐1 (2.5 mg weeks 0–1; 5 mg weeks 2–3; 10 mg weeks 4–7; 15 mg weeks 8–11) and 15 mg‐2 (2.5 mg weeks 0–3; 7.5 mg weeks 4–7; 15 mg weeks 8–11). The primary objective was to compare tirzepatide with placebo in HbA1c change from baseline at 12 weeks. Results Overall, 111 patients were randomized: placebo, 26; tirzepatide 12 mg, 29; tirzepatide 15 mg‐1, 28; tirzepatide 15 mg‐2, 28. The mean age was 57.4 years, HbA1c 8.4% and body mass index 31.9 kg/m2. At week 12, absolute HbA1c change from baseline (SE) was greater in the tirzepatide treatment groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, −1.7% [0.19]; 15 mg‐1, −2.0% [0.20]; 15 mg‐2, −1.8% [0.19]). The incidence of nausea was: placebo, 7.7%; 12 mg group, 24.1%; 15 mg‐1 group, 39.3%; 15 mg‐2 group, 35.7%. Three patients discontinued the treatment because of adverse events, one from each of the placebo, 12 mg and 15 mg‐1 groups. Conclusions Tirzepatide treatment for 12 weeks resulted in clinically significant reductions in HbA1c. This suggests that lower starting doses and smaller dose increments are associated with a more favourable side effect profile.
Databáze: OpenAIRE
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