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Poster Presentations: Clinical Diabetes/Therapeutics

993-P: A 12-Week, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of Three Dose-Escalation Algorithms of Tirzepatide, a Novel Dual GIP and GLP-1 Receptor Agonist, in Patients with Type 2 Diabetes

  1. JUAN P. FRIAS,
  2. MICHAEL A. NAUCK,
  3. JOANNA VAN,
  4. CHARLES BENSON,
  5. ROSS BRAY,
  6. ZVONKO MILICEVIC,
  7. AXEL HAUPT and
  8. DEBORAH A. ROBINS
  1. Los Angeles, CA, Bochum, Germany, Tustin, CA, Indianapolis, IN, Vienna, Austria
Diabetes 2019 Jun; 68(Supplement 1): -. https://doi.org/10.2337/db19-993-P
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Abstract

Initiating incretin hormone receptor agonist therapy at a low dose with gradual dose escalation may improve gastrointestinal (GI) tolerability. This randomized, double-blind, placebo-controlled study assessed the efficacy and tolerability of tirzepatide, using 3 different dose escalation algorithms in patients with type 2 diabetes compared with placebo after 12 weeks. The dose-escalations included 1 algorithm to achieve 12 mg top dose by the scheme of 4 mg and 8 mg, each for 4 weeks. The scheme for the first 15 mg top dose group (15 mg-1) was 2.5 mg for 2 weeks, followed by 5 mg for 2 weeks, and then 10 mg for 4 weeks. The scheme for the second 15 mg top dose group (15 mg-2) was 2.5 mg followed by 7.5 mg, each for 4 weeks. A total of 111 subjects were randomized. Mean age was 57.4 years, HbA1c was 8.4%, and BMI was 31.9 kg/m2. At Week 12, LS mean HbA1c% (SE) was 8.6 (0.21), 6.7 (0.19), 6.3 (0.20), 6.6 (0.19) in the placebo, 12 mg, 15 mg-1 and 15 mg-2 groups, respectively. Change from baseline (SE) in HbA1c was greater in tirzepatide 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]). Weight loss was greater in tirzepatide groups compared with placebo (placebo, -0.5 kg [0.86]; 12 mg, -5.3 kg [0.78]; 15 mg-1, -5.5 kg [0.80] and 15 mg-2, -5.7 kg [0.79]). The total incidence of nausea, vomiting and/or diarrhea was 11.5% with placebo, and 48.3%, 57.1% and 46.4% with tirzepatide 12 mg, 15 mg-1, and 15 mg-2 groups, respectively. GI AEs were mild to moderate in intensity. Tirzepatide resulted in clinically meaningful improvements in glycemic control and weight loss. A lower starting dose and a longer dose-escalation period resulted in lower incidence of GI AEs than in a previously published Phase 2 study.

Disclosure J.P. Frias: Advisory Panel; Self; Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Sanofi. Consultant; Self; Echosens, Genentech, Inc., Johnson & Johnson Diabetes Institute, Novo Nordisk Inc., Zafgen, Inc. Research Support; Self; AbbVie Inc., Akcea Therapeutics, Allergan, Amgen Inc., AstraZeneca, Bayer US, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Cirius Therapeutics, Elcelyx Therapeutics, Inc., Eli Lilly and Company, Enanta Pharmaceuticals, Inc., GENFIT, Intarcia Therapeutics, Inc., Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., NGM Biopharmaceuticals, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Oramed Pharmaceuticals, Pfizer Inc., Sanofi, TaiwanJ Pharmaceuticals Co., Ltd., Theracos, Inc. Speaker's Bureau; Self; Merck & Co., Inc., Sanofi. M.A. Nauck: Advisory Panel; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S. Research Support; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Merck Sharp & Dohme Corp., Novo Nordisk A/S. Speaker's Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sun Pharma. J. Van: Research Support; Self; Eli Lilly and Company, Genentech, Inc., Melior, Merck & Co., Inc., Mylan, Oramed Pharmaceuticals, Sanofi. C. Benson: Employee; Self; Eli Lilly and Company. R. Bray: Employee; Self; Eli Lilly and Company. Z. Milicevic: Employee; Self; Eli Lilly and Company. A. Haupt: Employee; Self; Lilly Diabetes. Stock/Shareholder; Self; Lilly Diabetes. D.A. Robins: Employee; Self; Eli Lilly and Company.

Funding Eli Lilly and Company

  • © 2019 by the American Diabetes Association.
http://www.diabetesjournals.org/content/license

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.

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Diabetes: 68 (Supplement 1)

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June 2019, 68(Supplement 1)
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993-P: A 12-Week, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of Three Dose-Escalation Algorithms of Tirzepatide, a Novel Dual GIP and GLP-1 Receptor Agonist, in Patients with Type 2 Diabetes
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993-P: A 12-Week, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of Three Dose-Escalation Algorithms of Tirzepatide, a Novel Dual GIP and GLP-1 Receptor Agonist, in Patients with Type 2 Diabetes
JUAN P. FRIAS, MICHAEL A. NAUCK, JOANNA VAN, CHARLES BENSON, ROSS BRAY, ZVONKO MILICEVIC, AXEL HAUPT, DEBORAH A. ROBINS
Diabetes Jun 2019, 68 (Supplement 1) 993-P; DOI: 10.2337/db19-993-P

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993-P: A 12-Week, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of Three Dose-Escalation Algorithms of Tirzepatide, a Novel Dual GIP and GLP-1 Receptor Agonist, in Patients with Type 2 Diabetes
JUAN P. FRIAS, MICHAEL A. NAUCK, JOANNA VAN, CHARLES BENSON, ROSS BRAY, ZVONKO MILICEVIC, AXEL HAUPT, DEBORAH A. ROBINS
Diabetes Jun 2019, 68 (Supplement 1) 993-P; DOI: 10.2337/db19-993-P
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